Tieu Et Al-2017-Cochrane Database of Systematic Reviews

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Cochrane Database of Systematic Reviews
Interconception care for women with a history of gestational

diabetes for improving maternal and infant outcomes (Review)
Tieu J, Shepherd E, Middleton P, Crowther CA
Tieu J, Shepherd E, Middleton P, Crowther CA.

Interconception care for women with a history of gestational diabetes for improving maternal and infant outcomes.
Cochrane Database of Systematic Reviews 2017, Issue 8. Art. No.: CD010211.
DOI: 10.1002/14651858.CD010211.pub3.
www.cochranelibrary.com
Interconception care for women with a history of gestational diabetes for improving maternal and infant
outcomes (Review)
Copyright © 2017 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Cochrane Trusted evidence.
Informed decisions.
Library Better health. Cochrane Database of Systematic Reviews
TABLE OF CONTENTS
HEADER......................................................................................................................................................................................................... 1
ABSTRACT..................................................................................................................................................................................................... 1
PLAIN LANGUAGE SUMMARY....................................................................................................................................................................... 2
BACKGROUND.............................................................................................................................................................................................. 3
OBJECTIVES.................................................................................................................................................................................................. 4
METHODS..................................................................................................................................................................................................... 4
RESULTS........................................................................................................................................................................................................ 6
Figure 1.................................................................................................................................................................................................. 7
DISCUSSION.................................................................................................................................................................................................. 7
AUTHORS' CONCLUSIONS........................................................................................................................................................................... 7
ACKNOWLEDGEMENTS................................................................................................................................................................................ 8
REFERENCES................................................................................................................................................................................................ 9
CHARACTERISTICS OF STUDIES.................................................................................................................................................................. 12
APPENDICES................................................................................................................................................................................................. 14
WHAT'S NEW................................................................................................................................................................................................. 18
CONTRIBUTIONS OF AUTHORS................................................................................................................................................................... 18
DECLARATIONS OF INTEREST..................................................................................................................................................................... 18
SOURCES OF SUPPORT............................................................................................................................................................................... 19
DIFFERENCES BETWEEN PROTOCOL AND REVIEW.................................................................................................................................... 19
INDEX TERMS............................................................................................................................................................................................... 19
Interconception care for women with a history of gestational diabetes for improving maternal and infant outcomes (Review) i
Informed decisions.
[Intervention Review]
Interconception care for women with a history of gestational diabetes

for improving maternal and infant outcomes
Joanna Tieu1, Emily Shepherd1, Philippa Middleton2, Caroline A Crowther3
1ARCH: Australian Research Centre for Health of Women and Babies, Robinson Research Institute, Discipline of Obstetrics and
Gynaecology, The University of Adelaide, Adelaide, Australia. 2Healthy Mothers, Babies and Children, South Australian Health and
Medical Research Institute, Adelaide, Australia. 3Liggins Institute, The University of Auckland, Auckland, New Zealand
Contact address: Joanna Tieu, ARCH: Australian Research Centre for Health of Women and Babies, Robinson Research Institute,
Discipline of Obstetrics and Gynaecology, The University of Adelaide, Women's and Children's Hospital, 1st floor, Queen Victoria
Building, 72 King William Road, Adelaide, South Australia, 5006, Australia. [email protected], [email protected].
Editorial group: Cochrane Pregnancy and Childbirth Group.

Publication status and date: New search for studies and content updated (no change to conclusions), published in Issue 8, 2017.
Citation: Tieu J, Shepherd E, Middleton P, Crowther CA. Interconception care for women with a history of gestational diabetes
for improving maternal and infant outcomes. Cochrane Database of Systematic Reviews 2017, Issue 8. Art. No.: CD010211. DOI:
10.1002/14651858.CD010211.pub3.
ABSTRACT
Background
Gestational diabetes mellitus (GDM) is associated with adverse health outcomes for mothers and their infants both perinatally and
long term. Women with a history of GDM are at risk of recurrence in subsequent pregnancies and may benefit from intervention in the
interconception period to improve maternal and infant health outcomes.
Objectives
To assess the effects of interconception care for women with a history of GDM on maternal and infant health outcomes.
Search methods
We searched Cochrane Pregnancy and Childbirth's Trials Register (7 April 2017) and reference lists of retrieved studies.
Selection criteria
Randomised controlled trials, including quasi-randomised controlled trials and cluster-randomised trials evaluating any protocol of
interconception care with standard care or other forms of interconception care for women with a history of GDM on maternal and infant
health outcomes.
Data collection and analysis

Two review authors independently assessed study eligibility. In future updates of this review, at least two review authors will extract data
and assess the risk of bias of included studies; the quality of the evidence will be assessed using the GRADE approach.
Main results
No eligible published trials were identified. We identified a completed randomised controlled trial that was designed to evaluate the effects
of a diet and exercise intervention compared with standard care in women with a history of GDM, however to date, it has only published
results on women who were pregnant at randomisation (and not women in the interconception period). We also identified an ongoing trial,
in obese women with a history of GDM planning a subsequent pregnancy, which is assessing the effects of an intensive lifestyle intervention,
supported with liraglutide treatment, compared with usual care. We also identified a trial that was designed to evaluate the effects of a
Interconception care for women with a history of gestational diabetes for improving maternal and infant outcomes (Review) 1
Informed decisions.
weight loss and exercise intervention compared with lifestyle education also in obese women with a history of GDM planning a subsequent
pregnancy, however it has not yet been published. These trials will be re-considered for inclusion in the next review update.
Authors' conclusions
The role of interconception care for women with a history of GDM remains unclear. Randomised controlled trials are required evaluating
different forms and protocols of interconception care for these women on perinatal and long-term maternal and infant health outcomes,
acceptability of such interventions and cost-effectiveness.
PLAIN LANGUAGE SUMMARY
Care prior to the next pregnancy for women diagnosed with gestational diabetes
What is the issue?
The aim of this Cochrane review was to look at the effects of specialised, targeted care given to mothers who have had a least one pregnancy
affected by gestational diabetes. Does this sort of care improve the health of the mother and her baby, during and after her next pregnancy?
We collected and analysed all relevant studies to answer this question (date of search: April 2017).
Why is this important?
Gestational diabetes (GD), also called gestational diabetes mellitus (GDM), is glucose intolerance arising during pregnancy. GDM can lead
to health complications for the mother. These complications might include high blood pressure during pregnancy and at the birth, pre-
eclampsia (high blood pressure plus protein in the urine), and the development of type 2 diabetes in the future. The birth is more likely to
be induced. The babies of mothers with GDM are more likely to be born by caesarean section, and to develop diabetes as children or young
adults. Women who experience GDM are at risk of developing it again in a subsequent pregnancy.
If targeted care between the birth of one child and the next pregnancy – known as interconception care – reduces the incidence of GDM,
then perhaps these health risks can be reduced, too.
Interconception care may include education, dietary and lifestyle advice, intervention with medication and careful monitoring of the
mother’s health, focusing on testing for glucose tolerance.
What evidence did we find?
We searched for trials which looked at the health outcomes for women and babies after specific interconception care, and compared the
outcomes for standard care (with no interconception care of this type). Our search identified one trial which has yet to issue a full set of
results, plus two further trials; one of these is still underway and the other has yet to be published.
What does this mean?
Because there are no studies currently available, there is not enough evidence at present to say if interconception care for women with a
history of GDM can help to improve the health of mothers and their infants. More high-quality studies are needed, which assess both short-
and long-term health outcomes for women and their babies, as well as evaluating the impact on the health services.
Informed decisions.
BACKGROUND oral glucose challenge test. Diagnostic testing commonly involves

either a 75 g or 100 g oral glucose tolerance test, with various
Description of the condition diagnostic cut-offs used. These are addressed in the Cochrane
reviews 'Screening and subsequent management for gestational
Gestational diabetes mellitus (GDM) is defined as 'carbohydrate
diabetes for improving maternal and infant health' (Tieu 2014) and
intolerance resulting in hyperglycaemia of variable severity with
'Different strategies for diagnosing gestational diabetes to improve
onset or first recognition during pregnancy' (WHO 1999). This
maternal and infant health' (Farrar 2015).
definition includes women who first present with type 1 or type
2 diabetes during pregnancy, or where diabetes was previously Women with a history of GDM are acknowledged as being at
undetected. Although GDM typically resolves following birth, it is high risk for both GDM recurrence and type 2 diabetes, and it is
associated with adverse outcomes for both mother and infant, both suggested that women with a history of GDM may require greater
in the perinatal period and in the long term. monitoring for glucose intolerance during subsequent pregnancies,
as such through early self-monitoring of blood glucose, or an early
In subsequent pregnancies of women with a history of GDM,
oral glucose tolerance test (NICE 2015).
one of the main issues is recurrence of GDM and the associated
outcomes. Irrespective of subsequent pregnancies, other long- Clinical features
term considerations for these women include the development of
type 2 diabetes, metabolic syndrome and the risk of cardiovascular Maternal
disease. GDM is usually diagnosed before women experience symptoms,
such as polyuria, polydipsia or fatigue. GDM is associated with
Epidemiology
increased rates of caesarean birth and pre-eclampsia (Dodd 2007).
The reported incidence of GDM varies between different As mentioned above, women who develop GDM represent a subset
populations and the method and criteria by which the diagnosis of the population prone to developing subsequent type 2 diabetes,
is made, with some studies estimating that between 1% and in addition to recurrent GDM in future pregnancies. Within 10 years
28% of pregnancies are affected by GDM (Jiwani 2012). Despite of women developing GDM, approximately half develop type 2
variation in diagnostic criteria, there is widespread agreement that diabetes (Kim 2002). Furthermore, there is increasing evidence
the prevalence of diabetes, including GDM, is increasing across that women with a history of GDM may also be at increased risk
the world, in line with the escalating prevalence of obesity. In of cardiovascular disease and metabolic syndrome (Reece 2009;
women with a history of GDM, recurrence occurs in 30% to 84% of Reece 2010; Vohr 2008).
subsequent pregnancies (Kim 2007).
Infant
A number of risk factors have been linked to GDM, including a
Excess insulin due to maternal hyperglycaemia acts in two ways
history of GDM or glucose intolerance (Kim 2007), family history
on the fetus. Firstly, insulin promotes fat deposition due to the
of first-degree relatives with GDM or type 2 diabetes, ethnicity
state of nutrient excess (Pedersen 1954; Whitelaw 1977). Insulin
(e.g. African, Hispanic, South or East Asian, Native American and
also acts as a growth factor, stimulating further growth of the
Pacific Islander), advanced maternal age, maternal high or low
infant in utero (Hunt 2007). Thus, fetal hyperinsulinaemia results
birthweight, high parity, a past history of a macrosomic (large)
in excessive growth of the fetus, leading to one of the major
baby or a stillbirth (Petry 2010), polycystic ovarian syndrome (Toulis
perinatal concerns in GDM, macrosomia (birthweight greater than
2009), and maternal overweight or obesity (body mass index (BMI)
4000 g). Macrosomia may lead to birth trauma including shoulder
equal to or greater than 25 kg/m2 or 30 kg/m2, respectively) (Torloni
dystocia, nerve palsies and fractures (Reece 2009; Reece 2010).
2009).
GDM is associated with respiratory distress syndrome, neonatal
Many of these risk factors are unmodifiable background hypoglycaemia (low blood glucose), hyperbilirubinaemia (high
characteristics of the women. It is therefore unsurprising that bilirubin levels), polycythaemia (excess red blood cells), and
women with a history of GDM are at an increased risk of recurrent hypocalcaemia (low calcium) (Reece 2009; Reece 2010). In utero
GDM. In addition to a history of GDM in a previous pregnancy, exposure to hyperglycaemia has long-lasting effects on the infant,
other risk factors for recurrence include ethnicity, maternal age, increasing their risk of future obesity and type 2 diabetes (Reece
prepregnancy obesity, weight gain between pregnancies, a short 2009; Reece 2010).
interpregnancy interval and the number of previous pregnancies
While there is relatively little reported on the effects of recurrent
affected by GDM (Gaudier 1992; Getahun 2010; Kwak 2008; Major
GDM on infants, infants born to mothers with recurrent GDM are
1998). Certain characteristics of the pregnancy affected by GDM
likely to be larger, as measured by birthweight, incidence of large-
have also been reported to increase the risk of recurrence,
for-gestational age, or macrosomia compared with infants born to
specifically, earlier diagnosis of GDM, insulin requirement for blood
mothers without recurrent GDM in a subsequent pregnancy (Spong
glucose control and higher infant birthweight (Gaudier 1992 ; Kwak
1998).
2008; MacNeill 2001; Major 1998).
Management of GDM
Screening and diagnosis of gestational diabetes
The importance of management for women with GDM has been
There is little consensus on the most appropriate methods by
recognised (Crowther 2005; Landon 2009), and several Cochrane
which to screen and diagnose GDM. Screening methods include
reviews have (or plan to) assess alternative management strategies
selective- (risk factor-) based screening, or universal screening,
for GDM (Alwan 2009), including lifestyle interventions (Brown
commonly performed between 24 and 28 weeks' gestation, with the
2017a), insulin (Brown 2016a), oral anti-diabetic pharmacological
use of random or fasting blood glucose concentrations and a 50 g
therapies (Brown 2017b), exercise (Brown 2017c), dietary
Informed decisions.
supplementation with myo-inositol (Brown 2016b), and different and potentially benefit women with a history of GDM. Reducing
intensities of glycaemic control (Martis 2016). maternal obesity itself may also lead to better maternal and infant
health outcomes outside of its potential effect in the prevention
Description of the intervention of GDM. Regardless of whether women subsequently become
pregnant, such interventions may improve the health of these
Interconception care may encompass a variety of interventions,
women.
including education, dietary and lifestyle advice, pharmacological
intervention and active surveillance for illness and complications. It There is little information on the value of pharmacological agents
includes care between the birth of one child to the next pregnancy. such as oral anti-diabetics for women with a history of GDM
in the preconceptual period; assessed in the Cochrane review,
Internationally, clinical practice guidelines and consensus
'Oral anti-diabetic agents for women with pre-existing diabetes
statements generally recommend postpartum assessment for
mellitus/impaired glucose tolerance or previous gestational diabetes
continuing glucose intolerance after six to 12 weeks, by oral glucose
mellitus' (Tieu 2010b). The use of oral anti-diabetic agents has
tolerance testing to detect type 2 diabetes, and on a regular basis
been predominantly in the setting of polycystic ovarian syndrome
thereafter (i.e. every one to three years thereafter depending on
or for prevention of type 2 diabetes in women with a history of
other risk factors) (ACOG 2013; ADA 2017; CDA 2013; Metzger 2007;
GDM. 'Interventions for the prevention of type 2 diabetes in women
Nankervis 2014; NICE 2015). Despite such recommendations, a
with previous gestational diabetes' will be the focus of a planned
high proportion of women with previous GDM do not have testing
Cochrane review (Li 2017).
for diabetes in the postpartum period (Blatt 2011). A Cochrane
review evaluating 'Reminder systems for women with previous GDM
Why it is important to do this review
to increase uptake of testing for type 2 diabetes or impaired glucose
tolerance', showed low-quality evidence supporting an increase in Women with a history of GDM are recognised to be at high risk
the uptake of testing for type 2 diabetes in women with previous for recurrence in subsequent pregnancies, type 2 diabetes and
GDM following the issue of postal reminders (Middleton 2014). cardiovascular disease, and therefore, for adverse maternal and
infant health outcomes. While management of GDM is worthwhile,
While often recommended, there is little evidence on what interconception care for these women also has the potential to
care women with a history of GDM should receive prior to improve maternal and infant health. Interconception care may also
a subsequent pregnancy. Clinical guidelines recommend that allow for detection and appropriate management of asymptomatic
women be assessed preconceptually for a medical review and/ pre-existing diabetes and provide an opportunity for risk factor
or an oral glucose tolerance test, with early evaluation for reduction and, potentially, prevention of recurrent GDM and its
glucose intolerance during pregnancy (ACOG 2013; NICE 2015). In sequelae.
addition to earlier identification and management of diabetes,
interconception care after the postpartum period would ideally Routine pre-pregnancy care and preconception care for women
aim to target the modifiable risk factors for GDM, thus improving with known diabetes mellitus are reviewed by the Cochrane
women's metabolic profiles. reviews 'Routine pre-pregnancy health promotion for improving
pregnancy outcomes' (Whitworth 2009) and 'Preconception care for
How the intervention might work diabetic women for improving maternal and infant health' (Tieu
2010).
In a survey of women with a history of GDM within the last five years,
while 90% understood that previous GDM placed women at high
OBJECTIVES
risk of type 2 diabetes, only 16% believed that they themselves were
at high risk of developing diabetes (Kim 2007b). This was partially To assess the effects of interconception care for women with a
explained by women planning to improve their behaviour in the history of gestational diabetes mellitus on maternal and infant
future. When women considered the risks if they continued their health outcomes.
current lifestyle, this risk perception rose to 39%. Importantly 85%
of these women had plans for risk-reducing behaviour (Kim 2007b). METHODS
Another survey comparing women with children and a history of
GDM with women with children without a history of GDM, found Criteria for considering studies for this review
that those with a history of GDM were more likely to smoke and less
likely to meet fruit and vegetable consumption recommendations Types of studies
(Kieffer 2006). Randomised controlled trials (RCTs), including quasi-RCTs and
cluster-RCTs. We plan to exclude cross-over trials. We plan to
The interconception period provides an opportunity to provide exclude trials presented only as abstracts where information on risk
advice on potential risks and possible interventions to improve of bias and primary or secondary outcomes cannot be obtained; we
health. Moreover, it provides the opportunity to identify plan to reconsider these trials for inclusion once the full publication
undiagnosed pre-existing diabetes. Since women with a history of is available.
GDM are at increased risk of diabetes, and pre-existing diabetes
in pregnancy is linked to poor maternal and infant health Types of participants
outcomes, it is important to identify and manage accordingly in the
interconception period. Women who have been diagnosed with gestational diabetes
mellitus (GDM) in a previous pregnancy. Diagnosis of GDM made
Risk factor reduction is a potential area of focus for these according to individual study criteria.
women, targeting modifiable risk factors such as maternal obesity
where dietary and lifestyle interventions could be implemented
Informed decisions.
Types of interventions Longer term
Any protocol of care compared with no care and other forms • GDM in a subsequent pregnancy
of interconception care. Interventions may continue during • Type 1 diabetes mellitus
pregnancy. • Type 2 diabetes mellitus
Types of outcome measures • Impaired glucose tolerance
• Cardiovascular health (e.g. blood pressure, hypertension,
For this update, we used the core outcome set agreed by consensus cardiovascular disease, metabolic syndrome)
between review authors of Cochrane Pregnancy and Childbirth
systematic reviews for prevention and treatment of gestational For children
diabetes mellitus (GDM) and pre-existing diabetes, which we
Fetuses/neonates
adapted, as appropriate for this review question.
• Stillbirth
Primary outcomes • Neonatal death
For women • Gestational age at birth
• GDM (diagnostic criteria as defined in individual trials) • Preterm birth (before 37 weeks' gestation; before 34 weeks'
gestation)
• Hypertensive disorders of pregnancy (including pre-eclampsia,
pregnancy-induced hypertension, eclampsia) • Apgar score less than seven at five minutes
• Caesarean section • Macrosomia
• Small-for-gestational age
For children
• Birthweight and z score
• Large-for-gestational age • Head circumference and z score
• Perinatal mortality (stillbirth or neonatal death) • Length and z score
• Mortality or morbidity composite (e.g. death, shoulder dystocia, • Ponderal index
bone fracture or nerve palsy) • Adiposity
Secondary outcomes • Shoulder dystocia
• Bone fracture
For women
• Nerve palsy
All women (interconception, and if pregnant, antenatal and postnatal)
• Respiratory distress syndrome
• Adherence to the intervention • Hypoglycaemia
• Behaviour changes associated with the intervention • Hyperbilirubinaemia
• Sense of well-being and quality of life
Children/adults
• Views of the intervention
• Glycaemic control during/at the end of the intervention (e.g. • Weight and z scores
HbA1c, blood glucose) • Height and z scores
• Pregnancy • Head circumference and z scores
• Weight gain • Adiposity (e.g. as measured by BMI, skinfold thickness)
• Body mass index (BMI) • Cardiovascular health (e.g. blood pressure, hypertension,
cardiovascular disease, metabolic syndrome)
Pregnant women
• Education, employment and social status/achievement
• Spontaneous abortion/miscarriage/therapeutic abortion • Type 1 diabetes mellitus
• Induction of labour • Type 2 diabetes mellitus
• Perineal trauma • Impaired glucose tolerance
• Placental abruption • Neurosensory disability
• Postpartum haemorrhage • Employment, education and social status/achievement
• Postpartum infection
For the use of health services
• Breastfeeding
• Postnatal depression • Number of hospital or health professional visits
• Number of antenatal visits or admissions
Pregnant women with GDM
• Length of antenatal stay
• Use of additional pharmacotherapy • Neonatal intensive care unit admission
• Hypoglycaemia • Length of postnatal stay (mother)
• Mortality • Length of postnatal stay (baby)
• Costs to families associated with the intervention
• Costs associated with the intervention
Informed decisions.
• Cost of maternal care Searching other resources

• Cost of infant care We searched the reference lists of retrieved studies.
Search methods for identification of studies We did not apply any language or date restrictions.
The following methods section of this review is based on a standard
template used by Cochrane Pregnancy and Childbirth.
For methods used in the previous version of this review, see Tieu
Electronic searches 2013.
We searched Cochrane Pregnancy and Childbirth’s Trials Register
by contacting their Information Specialist (7 April 2017). Two review authors independently assessed for inclusion the
reports identified as a result of the search strategy. No studies were
The Register is a database containing over 22,000 reports of eligible for inclusion. We would have resolved any disagreement
controlled trials in the field of pregnancy and childbirth. For full through discussion with a third person.
search methods used to populate Pregnancy and Childbirth’s Trials
Register including the detailed search strategies for CENTRAL, Full methods of data collection and analysis to be used in future
MEDLINE, Embase and CINAHL; the list of handsearched journals updates of this review, if eligible studies are identified, are given in
and conference proceedings, and the list of journals reviewed Appendix 1.
via the current awareness service, please follow this link to the
RESULTS
editorial information about Cochrane Pregnancy and Childbirth in
the Cochrane Library and select the ‘Specialized Register ’ section Description of studies
from the options on the left side of the screen.
The updated search of Cochrane Pregnancy and Childbirth's
Briefly, Cochrane Pregnancy and Childbirth’s Trials Register is register identified nine reports, relating to one trial (Koivusalo
maintained by their Information Specialist and contains trials 2016), which we have listed as awaiting further classification, and
identified from: one report relating to one trial (ISRCTN76189107) which we have
listed as ongoing.
1. monthly searches of the Cochrane Central Register of Controlled
Trials (CENTRAL); Koivusalo 2016 recruited 788 women including 235 women who
2. weekly searches of MEDLINE (Ovid); were not pregnant during their first study visit (women with
3. weekly searches of Embase (Ovid); a previous history of gestational diabetes mellitus (GDM) (187)
or a pre-pregnancy BMI ≥ 30 kg/m2 (48)), and assessed a diet
4. monthly searches of CINAHL (EBSCO);
and exercise intervention compared with standard care. To date,
5. handsearches of 30 journals and the proceedings of major however, results have only been reported for the subset of women
conferences; who were pregnant during the first study visit. See Characteristics
6. weekly current awareness alerts for a further 44 journals plus of studies awaiting classification.
monthly BioMed Central email alerts;
7. scoping search of clinical trials registries (ClinicalTrials.gov and We identified one new ongoing trial (ISRCTN76189107), which
the WHO International Clinical Trials Registry Platform (ICTRP)). plans to include 50 obese women with a previous history of GDM
pre-pregnancy, and assess the effects of an intensive lifestyle
Search results are screened by two people and the full text of intervention supported with liraglutide treatment compared with
all relevant trial reports identified through the searching activities standard care. In the previous version of this review we identified
described above is reviewed. Based on the intervention described, one additional trial (NCT00924599), which to date, has not been
each trial report is assigned a number that corresponds to a published (and is thus listed as ongoing). This trial planned to
specific Pregnancy and Childbirth review topic (or topics), and is include 12 obese women with a history of GDM and to assess the
then added to the Register. The Information Specialist searches effects of a pre-pregnancy weight loss and exercise intervention
the Register for each review using this topic number rather than compared with lifestyle education. See Characteristics of ongoing
keywords. This results in a more specific search set which has been studies.
fully accounted for in the relevant review sections (Studies awaiting
classification; Ongoing studies). See: Figure 1.
Informed decisions.
Figure 1. Study flow diagram.
Risk of bias in included studies in women with a history of GDM after birth, most notably
to increase follow-up testing for impaired glucose tolerance or
No randomised controlled trials were included in the review. diabetes (Clark 2009), and interventions such as metformin and
lifestyle modification to prevent type 2 diabetes (Ratner 2008) have
Effects of interventions
demonstrated benefit. It remains uncertain how this may translate
No randomised controlled trials were included in the review. to interventions in the interconception period for the prevention of
GDM recurrence.
DISCUSSION
In theory, the interconception period in these women represents a
Summary of main results time in a high-risk person's life for: identification and management
of undiagnosed impaired glucose tolerance and type 2 diabetes;
One randomised controlled trial (Koivusalo 2016) was identified to initiate lifestyle interventions to potentially improve maternal
that was designed to assess the effects of interconception and infant health outcomes; and to reinforce dietary and lifestyle
care on maternal and infant outcomes in women with a behaviours for prevention of long-term adverse health outcomes.
history of gestational diabetes mellitus (GDM), however to date, No results from randomised controlled trials have been published
has only published results on women who were pregnant at relating to the effects of interventions in this interconception period
randomisation, and not non-pregnant women. A further two trials for women with a history of GDM for improving health outcomes for
(ISRCTN76189107; NCT00924599), have been designed to assess women and their children. Given the potential benefits, it remains
the effects of lifestyle interventions for obese women with a history important to evaluate the effects of such interventions and identify
of GDM planning a subsequent pregnancy, however to date have the ideal form of intervention for these women.
not been published, or are ongoing.
AUTHORS' CONCLUSIONS
Women with a history of GDM are at increased risk of recurrence of
GDM in subsequent pregnancies, future impaired glucose tolerance Implications for practice
and diabetes, cardiovascular disease and their sequelae. Given the
potential poor outcomes identified in these women, they represent The role of interconception care for women with a history of
a group who could potentially benefit from intervention(s) aiming gestational diabetes mellitus (GDM) on maternal and infant health
to prevent these outcomes. A number of interventions studied outcomes remains unclear.
Informed decisions.
Implications for research ACKNOWLEDGEMENTS

Research should be conducted to investigate the effects of We acknowledge the support from the Cochrane Pregnancy and
interconception care for women with a history of GDM on health Childbirth editorial team in Liverpool, and the Australia and New
outcomes for mothers and their infants. Although such trials are Zealand Satellite of Cochrane Pregnancy and Childbirth (funded
faced with difficulties in identifying women in this time period by the Australian National Health and Medical Research Council
between pregnancies, women with a history of GDM do represent a (NHMRC)).
population at risk for potentially reversible poor health outcomes.
We thank Therese Dowswell from Cochrane Pregnancy and
Trials should consider the role of different forms of intervention Childbirth who provided support for this update. Therese
including dietary, lifestyle and pharmacological therapies, in Dowswell's contribution to this project was supported by the
addition to the duration of such interventions. Such trials should National Institute for Health Research (NIHR), via Cochrane
not only evaluate the effects on maternal and infant health programme grant funding to Cochrane Pregnancy and Childbirth.
outcomes, but also the acceptability and cost-effectiveness, to The views and opinions expressed therein are those of the authors
enable translation to clinical practice. Furthermore, future research and do not necessarily reflect those of the Systematic Reviews
should focus on long-term follow-up, evaluating the effects of such Programme, NIHR, National Health Service or the Department of
interventions on the long-term health outcomes associated with Health.
GDM for both mothers and their infants.
Informed decisions.
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Alho M, Eriksson JG, et al. Prevention of gestational diabetes Brown J, Crawford TJ, Alsweiler J, Crowther CA. Dietary
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produced in the stomach, in obese women with previous outcomes. Cochrane Database of Systematic Reviews 2017, Issue
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Informed decisions.
CHARACTERISTICS OF STUDIES
Characteristics of studies awaiting assessment [ordered by study ID]
Koivusalo 2016
Methods Randomised controlled trial.
Participants Inclusion criteria: women with a previous history of GDM or a pre-pregnancy BMI ≥ 30 kg/m2, ei-
ther planning pregnancy or pregnant at < 20 + 0 weeks’ gestation.
Exclusion criteria: age < 18 years; diabetes diagnosed before pregnancy; medications that influ-
ence glucose metabolism (e.g. oral corticosteroids and metformin); multiple pregnancies; physical
disability; current substance abuse; severe psychiatric disorders and significant difficulties to co-
operate (e.g. inadequate Finnish language skills).
Interventions Women randomised to structured counselling on diet and exercise or standard care.
Diet and exercise intervention
Women visited the study nurse every 3 months before and during pregnancy, and at 6 weeks, 6 and
12 months postpartum. Trained study nurses and nutritionists provided counselling, as below, and
weight targets were set: 5% to 10% weight loss before pregnancy for women with pre-pregnancy
BMI ≥ 25 kg/m2; no weight gain during the first 2 trimesters for women with pre-pregnancy BMI ≥ 30
kg/m2.
Dietary counselling was based on national Finnish nutritional guidelines. The 'plate model' was
used during the counselling sessions (filling half a plate with raw/cooked vegetables, one quarter
with starchy carbohydrates, and one quarter with meat, fish, beans, eggs or other proteins). The
aim was to achieve a total energy intake of 1600-1800 kcal/day; 40% to 50% from carbohydrates,
30% to 40% from fats, and 20% to 25% from protein. Women were encouraged to increase intake
of vegetables, legumes, fruits and berries; wholegrain and fibre; low-fat dairy and vegetable fats. In
the postpartum period, women received breastfeeding and infant nutrition counselling based on
national recommendations. Every 3 months women filled in 3-day food diaries. In addition to reg-
ular visits to the study nurse, women took part in structured group visits to a nutritionist, at enrol-
ment, during the first trimester and at 6 and 12 month postpartum; with additional visits arranged
if needed.
The aim of the physical activity counselling was to achieve a minimum of 30 minutes of moderate
intensity exercise (exercise during which the woman becomes at least slightly out of breath and
perspires but is still able to talk) 5 times/week or 50 minutes 3 times/week, and to adopt an overall
active lifestyle. An individual exercise program was planned for each woman during the counselling
visits, and modified as needed. Women also received pedometers, with a recommendation of at
least 10,000 steps/day. Women had the option of attending guided exercise groups, or got tickets
(e.g. to public swimming pooled once a week. Physical activity logbooks were used.
Standard care
Women received basic dietary and exercise information leaflets similar to those provided at prima-
ry health care centres at the time of enrolment. During pregnancy, they received usual health edu-
cation provided at their local antenatal clinic.
Outcomes Primary outcome: GDM.
Notes Funding: "This study was funded by the Ahokas Foundation, the Finnish Foundation for Cardiovas-
cular Disease, Special State Subsidy for Health Science Research of Helsinki University Central Hos-
pital, Samfundet Folkhälsan, The Finnish Diabetes Research Foundation, the State Provincial Of-
fice of Southern Finland, and The Social Insurance Institution of Finland. The funders have not had
any role in designing or conducting the study; in the collection, management, analysis, or interpre-
tation of the data; in the preparation, review, or approval of the manuscript; and in the decision to
submit the manuscript for publication".
Informed decisions.
Koivusalo 2016 (Continued)

Declarations of interest: "No potential conflicts of interest relevant to this article were reported".
Between February 2008 and November 2011, 788 women were recruited into the study. 235 were
non-pregnant and 493 pregnant during the first study visit. In the non-pregnant and pregnant
groups, 79.6% (women = 187) and 40.4% (women = 199), respectively, had a history of previous
GDM.
To date, results have only been published for the women who were pregnant during the first study
visit.
Last correspondence with Saila Koivusalo 01/12/2016 indicated manuscript relating specifically to
non-pregnant women with a history of GDM has not yet been published.
BMI: body mass index

GDM: gestational diabetes mellitus
Characteristics of ongoing studies [ordered by study ID]
ISRCTN76189107
Trial name or title An open-label randomized trial of an intensive lifestyle package supported with Liraglutide treat-
ment in obese, non-pregnant women with previous history of Gestational Diabetes Mellitus.
Participants Inclusion criteria: severe obesity (BMI ≥ 35 kg/m2) without type 2 and with previous GDM (with or
without insulin); willing to give written informed consent and to comply with the requirements of
this study protocol; aged ≥ 18 years at baseline; planning a pregnancy within the next 1 to 2 years;
negative pregnancy test; contraception during the study period.
Exclusion criteria: allergy/sensitivity to study medication; pregnant or breast feeding or consider-

ing becoming pregnant during the study period; medical disorder requiring medication other than
stable hypertension, hypothyroidism, polycystic ovarian syndrome; ongoing abuse of alcohol or
narcotics; family or personal history of multiple endocrine neoplasia type 2 or familial medullary
thyroid carcinoma; personal history of non-familial medullary thyroid carcinoma; history of acute
or chronic pancreatitis; obesity induced by drug treatment; use of approved weight lowering phar-
macotherapy; previous surgical treatment of obesity; history of major depressive disorder or sui-
cide attempt; uncontrolled hypertension; unable to provide written informed consent.
Interventions Intervention: a treatment package of an intensive lifestyle approach (including diet and physical
activity advice) supported by a daily treatment of liraglutide for a period of 6 months.
Control: usual care.
Outcomes Primary outcomes: proportion of eligible women who would agree to participate in the study; ac-
ceptability of women of taking daily liraglutide injections; proportion of women that complied with
the study protocol and completed the study intervention.
Secondary outcomes: fasting glucose; glucose homeostasis (OGTT, HbA1c, HOMA-IR); inflamma-
tory markers (C-reactive protein); weight loss; GDM and/or impaired glucose tolerance in a subse-
quent pregnancy.
Starting date Overall: September 2016; recruitment: April 2017; planned end date: December 2020.
Contact information Professor Fionnuala McAuliffe, UCD Perinatal Research Centre, Obstetrics and Gynaecology, School
of Medicine, University College Dublin, National Maternity Hospital, Dublin, Ireland
Phone: +353 1 6373216
Email: [email protected]
Informed decisions.
ISRCTN76189107 (Continued)
Notes Target recruitment: 50.
Sponsor: Clinical Research Centre, University College Dublin.
NCT00924599
Trial name or title A pilot study using weight loss and exercise to prevent recurring gestational diabetes in obese
women.
Participants Inclusion criteria: 18 to 40 year old women; English or Spanish speaking; GDM in last pregnancy;
BMI 30 to 40 kg/m2; 1 to 5 years since last pregnancy; non-smoking; planning to have a baby but
willing to use birth control during a 3-month weight loss program.
Exclusion criteria: 3 or more miscarriages; history of infertility; type 1 or type 2 diabetes; any
weight loss since last pregnancy (based on last pre-pregnancy weight); history of major psychiatric
illness, drug abuse, or unsafe dieting practices; history of bariatric surgery, major medical condi-
tions that prohibit physical activity or dietary intervention.
Interventions Weight loss and exercise: women attended sessions focused on healthy weight loss, healthy eat-
ing and exercise; weekly sessions for 12 weeks followed by monthly group meetings until concep-
tion; aimed for loss of 7% of body weight and increased physical activity to 2.5 hours per week.
Lifestyle education: women received education focusing on learning about healthy eating and
healthy activity, stress reduction techniques, ways of increasing activity; once a month for 3
months, then once a month until conception.
Outcomes Primary outcome: GDM not present in pregnancy.
Starting date Start date: June 2009; study completion: June 2014. No manuscript identified as yet.
Contact information Associate Professor, Suzanne Phelan, California Polytechnic State University-San Luis Obispo.
Notes Enrolment: 12 women.
Sponsor: California Polytechnic State University-San Luis Obispo.
BMI: body mass index

GDM: gestational diabetes mellitus
HbA1c: glycated haemoglobin
HOMA-IR: homeostatic model assessment - insulin resistance
OGTT: oral glucose tolerance test
APPENDICES
Appendix 1. Methods of data collection and analysis to be used in future updates of this review
The following methods of data collection and analysis are based on Cochrane Pregnancy and Childbirth standard methods text template.
Selection of studies
Two review authors will independently assess for inclusion all the potential studies we identify as a result of the search strategy. We will
resolve any disagreement through discussion or, if required, we will consult a third author.
Informed decisions.
Data extraction and management

We will design a form to extract data. For eligible studies, two review authors will extract the data using the agreed form. We will resolve
discrepancies through discussion or, if required, we will consult the third author. We will enter data into Review Manager software (RevMan
2014) and check the data for accuracy.
When information regarding any of the above is unclear, we will attempt to contact authors of the original reports to provide further details.
Assessment of risk of bias in included studies

Two review authors will independently assess risk of bias for each study using the criteria outlined in the Cochrane Handbook for Systematic
Reviews of Interventions (Higgins 2011). We will resolve any disagreement by discussion or by involving a third assessor.
(1) Random sequence generation (checking for possible selection bias)

We will describe for each included study the method used to generate the allocation sequence in sufficient detail to allow an assessment
of whether it should produce comparable groups.
We will assess the method as:
• low risk of bias (any truly random process, e.g. random number table; computer random number generator);
• high risk of bias (any non-random process, e.g. odd or even date of birth; hospital or clinic record number); or
• unclear risk of bias.
(2) Allocation concealment (checking for possible selection bias)

We will describe for each included study the method used to conceal allocation to interventions prior to assignment and will assess whether
intervention allocation could have been foreseen in advance of, or during recruitment, or changed after assignment.
We will assess the methods as:
• low risk of bias (e.g. telephone or central randomisation; consecutively numbered sealed opaque envelopes);
• high risk of bias (open random allocation; unsealed or non-opaque envelopes, alternation; date of birth); or
(3.1) Blinding of participants and personnel (checking for possible performance bias)
We will describe for each included study the methods used, if any, to blind study participants and personnel from knowledge of which
intervention a participant received. We will consider that studies are at low risk of bias if they were blinded, or if we judge that the lack of
blinding would be unlikely to affect results. We will assess blinding separately for different outcomes or classes of outcomes.
• low, high or unclear risk of bias for participants; and

• low, high or unclear risk of bias for personnel.
(3.2) Blinding of outcome assessment (checking for possible detection bias)

We will describe for each included study the methods used, if any, to blind outcome assessors from knowledge of which intervention a
participant received. We will assess blinding separately for different outcomes or classes of outcomes.
We will assess methods used to blind outcome assessment as:
• low, high or unclear risk of bias.
(4) Incomplete outcome data (checking for possible attrition bias due to the amount, nature and handling of incomplete outcome
data)
We will describe for each included study, and for each outcome or class of outcomes, the completeness of data including attrition and
exclusions from the analysis. We will state whether attrition and exclusions were reported and the numbers included in the analysis at
each stage (compared with the total randomised participants), reasons for attrition or exclusion where reported, and whether missing data
were balanced across groups or were related to outcomes. Where sufficient information is reported, or can be supplied by the trial authors,
we will re-include missing data in the analyses which we undertake.
We will assess methods as:
• low risk of bias (e.g. no missing outcome data; missing outcome data balanced across groups);
Informed decisions.
• high risk of bias (e.g. numbers or reasons for missing data imbalanced across groups; ‘as treated’ analysis done with substantial
departure of intervention received from that assigned at randomisation); or
(5) Selective reporting (checking for reporting bias)

We will describe for each included study how we investigated the possibility of selective outcome reporting bias and what we found.
• low risk of bias (where it is clear that all of the study’s prespecified outcomes and all expected outcomes of interest to the review have
been reported);
• high risk of bias (where not all the study’s prespecified outcomes have been reported; one or more reported primary outcomes were
not prespecified; outcomes of interest are reported incompletely and so cannot be used; study fails to include results of a key outcome
that would have been expected to have been reported); or
(6) Other bias (checking for bias due to problems not covered by (1) to (5) above)
We will describe for each included study any important concerns we have about other possible sources of bias.
(7) Overall risk of bias

We will make explicit judgements about whether studies are at high risk of bias, according to the criteria given in the Cochrane Handbook
(Higgins 2011). With reference to (1) to (6) above, we will assess the likely magnitude and direction of the bias and whether we consider it
is likely to impact on the findings. We will explore the impact of the level of bias through undertaking sensitivity analyses - see Sensitivity
analysis.
Assessment of the quality of the evidence using the GRADE approach

We will assess the quality of the evidence using the GRADE approach as outlined in the GRADE handbook in order to assess the quality of the
body of evidence relating to the following outcomes for the main comparison. We will use the Cochrane Pregnancy and Childbirth GRADE
core outcome set for reviews of prevention and treatment of gestational diabetes mellitus (GDM) and pre-existing diabetes in pregnancy,
adapted for this review question.
For women
• Gestational diabetes mellitus (GDM) (diagnostic criteria as defined in individual trials)

• Hypertensive disorders of pregnancy (including pre-eclampsia, pregnancy-induced hypertension, eclampsia)
• Caesarean section
• Perineal trauma
• Weight gain
• Postnatal depression
• Type 2 diabetes mellitus
For children
Fetuses/neonates
• Large-for-gestational age
• Perinatal mortality (stillbirth or neonatal death)
• Mortality or morbidity composite (e.g. death, shoulder dystocia, bone fracture or nerve palsy)
• Hypoglycaemia
Children/adults
• Adiposity (e.g. as measured by body mass index (BMI), skinfold thickness)

• Type 2 diabetes mellitus
• Neurosensory disability
We will use the GRADEpro Guideline Development Tool to import data from Review Manager 5.3 (RevMan 2014) in order to create ’Summary
of findings’ tables. A summary of the intervention effect and a measure of quality for each of the above outcomes will be produced using
the GRADE approach. The GRADE approach uses five considerations (study limitations, consistency of effect, imprecision, indirectness and
publication bias) to assess the quality of the body of evidence for each outcome. The evidence can be downgraded from 'high quality' by
Informed decisions.
one level for serious (or by two levels for very serious) limitations, depending on assessments for risk of bias, indirectness of evidence,
serious inconsistency, imprecision of effect estimates or potential publication bias.
Measures of treatment effect

Dichotomous data
For dichotomous data, we will present results as summary risk ratios (RRs) with 95% confidence intervals (CIs).
Continuous data
For continuous data, we will use the mean difference (MD) if outcomes are measured in the same way between trials. We will use the
standardised mean difference (SMD) to combine trials that measure the same outcome, but use different methods.
Unit of analysis issues

Cluster-randomised trials
We will include cluster-randomised trials in the analyses along with individually-randomised trials. We will adjust their sample sizes or
standard errors using the methods described in the Cochrane Handbook using an estimate of the intracluster correlation coefficient (ICC)
derived from the trial (if possible), or from another source (Higgins 2011). If ICCs from other sources are used, we will report this and
conduct sensitivity analyses to investigate the effect of variation in the ICC. If we identify both cluster-randomised trials and individually-
randomised trials, we plan to synthesise the relevant information. We will consider it reasonable to combine the results from both if there
is little heterogeneity between the study designs and the interaction between the effect of intervention and the choice of randomisation
unit is considered to be unlikely.
We will also acknowledge heterogeneity in the randomisation unit and perform a separate meta-analysis.
Cross-over trials
We will exclude cross-over trials from this review.
Multi-armed trials
Where a multi-armed trial is included, we will record and include all outcome data in the review as two-arm comparisons. We will include
the data for the different arms in independent two-arm comparisons in separate meta-analyses. In instances where we cannot include the
data in separate comparisons, we will combine it to create a single pair-wise comparison (Higgins 2011). If the control group is shared by
two or more study arms, we will divide the control group between relevant subgroup categories to avoid double-counting the participants
(for dichotomous data we will divide the events and the total population, while for continuous data we will assume the same mean and
standard deviation (SD) but will divide the total population). We will describe the details in the 'Characteristics of included studies' tables.
Dealing with missing data

For included studies, we will note levels of attrition. We will explore the impact of including studies with high levels of missing data in the
overall assessment of treatment effect by using sensitivity analysis.
We will carry out all outcome analyses, as far as possible, on an intention-to-treat basis i.e. we will attempt to include all participants
randomised to each group in the analyses. The denominator for each outcome in each trial will be the number randomised minus any
participants whose outcomes are known to be missing.
Assessment of heterogeneity
We will assess statistical heterogeneity in each meta-analysis using the Tau2, I2 and Chi2 statistics. We will regard heterogeneity as
substantial if an I2 is greater than 30% and either a Tau2 is greater than zero, or there is a low P value (less than 0.10) in the Chi2 test for
heterogeneity.
Assessment of reporting biases

If there are 10 or more studies in the meta-analysis, we will investigate reporting biases (such as publication bias) using funnel plots. We
will assess funnel plot asymmetry visually. If asymmetry is suggested by a visual assessment, we will perform exploratory analyses to
investigate it.
Data synthesis
We will carry out statistical analysis using the Review Manager software (RevMan 2014). We will use fixed-effect meta-analysis for combining
data where it is reasonable to assume that studies are estimating the same underlying treatment effect, i.e. where trials are examining the
same intervention, and the trials’ populations and methods are judged sufficiently similar. If there is clinical heterogeneity sufficient to
expect that the underlying treatment effects differ between trials, or if substantial statistical heterogeneity is detected, we will use random-
effects meta-analysis to produce an overall summary if an average treatment effect across trials is considered clinically meaningful.
Informed decisions.
The random-effects summary will be treated as the average of the range of possible treatment effects and we will discuss the clinical
implications of treatment effects differing between trials. If the average treatment effect is not clinically meaningful, we will not combine
trials. If we use random-effects analyses, we will present the results as the average treatment effect with 95% CIs, and the estimates of
Tau2 and I2.
Subgroup analysis and investigation of heterogeneity

If we identify substantial heterogeneity, we will investigate it using subgroup analyses and sensitivity analyses. We will consider whether
an overall summary is meaningful, and if it is, use random-effects analysis to produce it.
We plan to carry out the following subgroup analyses.
• Periconceptual BMI (e.g. underweight versus normal range versus overweight versus obese versus morbidly obese).
• Polycystic ovarian syndrome (yes versus no).
• Diagnostic criteria for GDM in previous pregnancy (e.g. International Association of Diabetes and Pregnancy Study Groups criteria
(IADPSG 2010) versus other).
• Management of GDM in previous pregnancy (e.g. non-pharmacological measures (dietary and lifestyle advice) versus oral anti-diabetic
agents versus insulin).
• Ethnicity (e.g. high risk versus low risk).
• Pregnancy interval (e.g. estimated date of delivery less than one year from last birth versus one year to five years from last birth versus
more than five years from last birth).
We will restrict subgroup analyses to the review's primary outcomes.
We will assess differences between subgroups by interaction tests available within RevMan (RevMan 2014). We will report the results of
subgroup analyses quoting the Chi2 statistic and P value, and the interaction test I2 value.
Sensitivity analysis
We plan to carry out sensitivity analysis on primary outcomes to explore the effect of trial quality where there is an overall high risk of bias
associated with included trials or where quasi-randomised or cluster-randomised trials are included in the review. We will consider a study
to be at overall high risk of bias if both concealment of allocation and attrition rates are assessed as being at high risk of bias. We plan
to exclude studies of poor quality from the analysis (those rating as high risk in total overall risk of bias) or quasi-randomised or cluster-
randomised trials in order to assess for any substantive difference in the overall result.
WHAT'S NEW
Date Event Description
7 April 2017 New search has been performed Search updated and one new trial listed as 'awaiting classifica-
tion', and one new trial listed as 'ongoing'. Planned methods up-
dated.
7 April 2017 New citation required but conclusions No change to conclusions.

have not changed
CONTRIBUTIONS OF AUTHORS
Emily Shepherd wrote the update of this review with regular input and feedback from Joanna Tieu, Philippa Middleton and Caroline
Crowther.
DECLARATIONS OF INTEREST
Joanna Tieu: is supported by an NHMRC postgraduate scholarship and Arthritis Australia Ken Muirden fellowship (jointly funded by the
Australian Rheumatology Association and Roche).
Emily Shepherd: none known.
Philippa Middleton: none known.
Caroline A Crowther: none known.

Informed decisions.
SOURCES OF SUPPORT
Internal sources
• ARCH: Australian Research Centre for Health of Women and Babies, Robinson Research Institute, The University of Adelaide, Australia.
External sources
• Department of Health and Ageing, Australia.
• NHMRC: National Health and Medical Research Council, Australia.
Funding for the Pregnancy and Childbirth Australian and New Zealand Satellite
• NIHR: National Institute for Health Research, UK.
NIHR Cochrane Programme Grant Project: 13/89/05 – Pregnancy and childbirth systematic reviews to support clinical guidelines
DIFFERENCES BETWEEN PROTOCOL AND REVIEW

In this update of the review:
• we updated the outcomes, using the standard outcome set agreed by consensus between review authors of Cochrane Pregnancy
and Childbirth systematic reviews for prevention and treatment of gestational diabetes mellitus and pre-existing diabetes (which we
adapted, as appropriate for this review question);
• we updated the planned methods to be in line with those in the standard template used by Cochrane Pregnancy and Childbirth
(including use of the GRADE approach to assess the quality of the body of evidence and the use of ’Summary of findings’ tables).
INDEX TERMS
Medical Subject Headings (MeSH)

Diabetes, Gestational [*prevention & control]; Preconception Care [*methods]; Secondary Prevention
MeSH check words

Female; Humans; Infant; Pregnancy

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Cochrane

Interconception care for women with a history of gestational

Tieu J, Shepherd E, Middleton P, Crowther CA

Tieu J, Shepherd E, Middleton P, Crowther CA.

Interconception care for women with a history of gestational diabetes

Joanna Tieu1, Emily Shepherd1, Philippa Middleton2, Caroline A Crowther3

Editorial group: Cochrane Pregnancy and Childbirth Group.

Data collection and analysis

PLAIN LANGUAGE SUMMARY

What is the issue?

Why is this important?

What evidence did we find?

What does this mean?

BACKGROUND oral glucose challenge test. Diagnostic testing commonly involves

Types of interventions Longer term

• Cost of maternal care Searching other resources

Figure 1. Study flow diagram.

Implications for research ACKNOWLEDGEMENTS

References to studies awaiting assessment NCT00924599 {published data only}

CDA 2013 Jiwani 2012

Clark 2009 Kieffer 2006

Farrar 2015 Kwak 2008

Gaudier 1992 Landon 2009

Hunt 2007 Major 1998

IADPSG 2010 Martis 2016

RevMan 2014 [Computer program]

Characteristics of studies awaiting assessment [ordered by study ID]

Diet and exercise intervention

Outcomes Primary outcome: GDM.

Koivusalo 2016 (Continued)

BMI: body mass index

Characteristics of ongoing studies [ordered by study ID]

Methods Randomised controlled trial.

Exclusion criteria: allergy/sensitivity to study medication; pregnant or breast feeding or consider-

Control: usual care.

Phone: +353 1 6373216

Notes Target recruitment: 50.

Sponsor: Clinical Research Centre, University College Dublin.

Methods Randomised controlled trial.

Outcomes Primary outcome: GDM not present in pregnancy.

Notes Enrolment: 12 women.

Sponsor: California Polytechnic State University-San Luis Obispo.

BMI: body mass index

Data extraction and management

Assessment of risk of bias in included studies

(1) Random sequence generation (checking for possible selection bias)

We will assess the method as:

(2) Allocation concealment (checking for possible selection bias)

We will assess the methods as:

We will assess the methods as:

• low, high or unclear risk of bias for participants; and

(3.2) Blinding of outcome assessment (checking for possible detection bias)

We will assess methods used to blind outcome assessment as:

• low, high or unclear risk of bias.

We will assess methods as:

(5) Selective reporting (checking for reporting bias)

We will assess the methods as:

(7) Overall risk of bias

Assessment of the quality of the evidence using the GRADE approach

• Gestational diabetes mellitus (GDM) (diagnostic criteria as defined in individual trials)