The American College of

Obstetricians and Gynecologists

WOMENS HEALTH CARE PHYSICIANS

P R AC T I C E
BUL L E T I N

clinical management guidelines for obstetrician gynecologists

Number 130, October 2012

(Replaces Practice Bulletin Number 31, October 2001

and Committee Opinion No. 419, October 2008)

Prediction and Prevention of

Preterm Birth
Preterm birth is the leading cause of neonatal mortality in the United States, and preterm labor precedes approximately 50% of preterm births (1, 2). Neonatal intensive care has improved the survival rate for neonates at the cusp
of viability, but it also has increased the proportion of survivors with disabilities (3). The incidence of multiple births
also has increased along with the associated risk of preterm delivery (4). The purpose of this document is to describe
the various methods proposed for identifying and treating asymptomatic women at increased risk of preterm birth and
the evidence for their roles in clinical practice.

Background
Spontaneous preterm birth includes birth that follows preterm labor, preterm spontaneous rupture of membranes,
and cervical insufficiency, but does not include indicated
preterm delivery for maternal or fetal conditions (5).
The preterm birth rate (birth at less than 37 completed
weeks of gestation per 100 total births) increased more
than 20% from 1990 to 2006. However, decreases in
birth rates for both early preterm birth (earlier than 34
weeks of gestation) and late preterm birth (34 0/736 6/7
weeks of gestation) contributed to a decrease in the overall preterm birth rate between 2008 (12.3%) and 2009
(12.18%) (1). The risk of poor birth outcome generally
decreases with advancing gestational age. Although risks
are greatest for neonates born before 34 weeks of gestation, infants born after 34 weeks of gestation but before
37 weeks of gestation are still more likely to experience
delivery complications, long-term impairment, and early
death than those born later in pregnancy (6).
Infants born prematurely have increased risks of
mortality and morbidity throughout childhood, especially

during the first year of life. In the absence of more comprehensive tests of fetal and neonatal status, gestational
age is a common surrogate for presumed functional maturity. Although age is related to maturity, no easily identified gestational age boundary exists between a premature
neonate and a mature neonate. The risks of perinatal,
neonatal, and infant morbidity and mortality are lowest
for infants born between 39 0/7 weeks of gestation and
40 6/7 weeks of gestation. These risks increase as gestational age at birth decreases, with morbidity reported at
37 weeks of gestation and even 38 weeks of gestation in
some series (7, 8).

Risk Factors
One of the strongest clinical risk factors for preterm birth
is a prior preterm birth (9). Maternal history of preterm
birth is commonly reported to confer a 1.5-fold to 2-fold
increased risk in a subsequent pregnancy. Importantly,
the number of prior preterm births and the gestational
age at the prior delivery significantly affect the recurrence risk of preterm birth (10). A preterm birth followed
by delivery at term confers lower risk than the opposite

Committee on Practice BulletinsObstetrics. This Practice Bulletin was developed by the Committee on Practice BulletinsObstetrics with the assistance of Jay Iams, MD, Gary Dildy, MD, George Macones, MD, and Neil Silverman, MD. The information is designed to aid practitioners in making decisions about appropriate obstetric and gynecologic care. These guidelines should not be construed as dictating an exclusive course of treatment or procedure.
Variations in practice may be warranted based on the needs of the individual patient, resources, and limitations unique to the institution or type of practice.

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OBSTETRICS & GYNECOLOGY

sequence (10, 11). For women with a prior preterm twin

birth, the risk of preterm birth in a subsequent singleton
gestation varies according to the gestational age at twin
delivery, with a recurrence risk as high as 40% when a
prior twin birth was before 30 weeks of gestation (12, 13).
Short cervical length measured by transvaginal ultrasonography also has been associated with an increased
risk of preterm birth (1416). Short cervical length is
most commonly defined as less than 25 mm, usually
before 24 weeks of gestation, but up to 28 weeks of gestation in some series. It is a cutoff that has been associated
with an increased risk of preterm birth in screened populations (15, 17). Clinically, the shorter the cervical length,
the greater the risk of preterm birth.
Additional proposed risk factors for preterm birth
include aspects of obstetric and gynecologic history,
demographic characteristics, current pregnancy complications, and behavioral factors. However, data are inconsistent about whether these factors are actually causative for
preterm birth. Preconception care allows an opportunity
to assess risk factors and provide counseling for women
with risk factors that can be modified, such as smoking
and optimal control of underlying chronic diseases (18).
A history of cervical surgery, including conization
and loop electrosurgical excision procedure, traditionally has been thought to be a risk factor for preterm
birth because of associated cervical injury, but this relationship also may be related to environmental, factors,
behavioral factors, or both (such as smoking) that underlie the progression of cervical dysplasia (19, 20). Uterine
instrumentation (eg, dilation and curettage) also has been
associated with an increased risk of preterm birth in
some, but not all, studies; the mechanism is unclear, but
intrauterine microbial colonization, injury to the endometrium, or both, together with host and environmental
factors, has been suggested (21).
Other factors during a current pregnancy that have
been associated with an increased risk of preterm
birth include vaginal bleeding, urinary tract infections
(UTIs), genital tract infections, and periodontal disease.
However, treatments for any of these potential risk factors have not been definitively demonstrated to result in
a decreased risk of preterm birth. Early studies of the
role of UTIs in preterm birth have demonstrated an association between untreated asymptomatic bacteriuria in
early pregnancy and increased rates of preterm birth (22,
23). However, subsequent meta-analyses have reported
conflicting results. One early report showed that untreated asymptomatic bacteriuria significantly increased rates
of low birth weight and preterm delivery (24). However,
later analyses, including one study of more than 25,000
births, and a Cochrane review, have failed to confirm
this finding (25, 26). Therefore, the association reported

VOL. 120, NO. 4, OCTOBER 2012

between treating UTIs in pregnancy and preventing preterm birth may be related to preventing progression of
subclinical infections to pyelonephritis (25, 27). In addition, women with periodontal disease have an increased
risk of preterm birth that is not affected by periodontal
care. This suggests that the increased risk is caused by
associated traits rather than a causal linkage (2831). In
fact, active treatment of periodontitis in pregnancy has
been shown in one study to potentially increase the risk
of spontaneous preterm birth (30).
Behavioral risk factors for preterm birth include
low maternal prepregnancy weight, smoking, substance
abuse, and short interpregnancy interval. Low maternal
body mass index (less than 19.8; calculated as weight
in kilograms divided by height in meters squared) has
been regularly found to be associated with an increased
risk of preterm birth (32, 33). Smoking is associated
with an increased risk of preterm birth and, unlike most
other risks, is amenable to intervention during pregnancy
(34, 35). An epidemiologic review of three U.S. studies
showed that the risk of adverse birth outcomes, including preterm birth, was lowest when the interpregnancy
interval was 1823 months and increased when the interval fell outside of this range (36).

Screening Modalities
Transvaginal cervical ultrasonography has been shown
to be a reliable and reproducible way to assess the length
of the cervix (37). This is in contrast to transabdominal
ultrasound evaluation of the cervix. Unlike the transabdominal approach, transvaginal cervical ultrasonography
is not affected by maternal obesity, position of the cervix, and shadowing from the fetal presenting part (38,
39). In addition, unlike digital examination, transvaginal
ultrasonography can help identify the presence of other
ultrasound risk markers for preterm delivery, such as
the presence of intraamniotic debris (a possible sign of
intrauterine microbial colonization) and choriodecidual
separation (40, 41).
When performed by trained operators, cervical
length screening by transvaginal ultrasonography is safe,
highly reproducible, and more predictive than transabdominal ultrasound screening. Using a method in which
the transvaginal probe is placed in the anterior fornix
of the vagina with an empty maternal bladder results in
measurements with interobserver variation of 510%
(37). Measurement of the cervical length in this manner
identifies a faint line of echodensity between internal and
external os, avoiding undue pressure on the cervix that
might increase its apparent length. The cervical length is
the shortest of three measurements taken between calipers placed at the internal os and external os (15, 42). As
an independent finding, cervical funneling does not add

Practice Bulletin

Prediction and Prevention of Preterm Birth

965

appreciably to the preterm delivery risk associated with a

shortened cervical length (43).
Other specific tests and monitoring modalities,
such as fetal fibronectin screening, bacterial vaginosis
testing, and home uterine activity monitoring have been
proposed to assess a womans risk of preterm delivery.
However, available interventional studies based on the
use of these tests for screening asymptomatic women
have not demonstrated improved perinatal outcomes
(4446). Thus, these methods are not recommended as
screening strategies.
In addition, interventions, such as pharmacotherapy
with indomethacin or antibiotics, activity restriction, or
supplementation with omega-3 fatty acids have not been
evaluated in the context of randomized trials for women
with short cervical length, and are not recommended as
clinical interventions for women with an incidentally
diagnosed short cervical length. Although maternal dietary
fish consumption has been associated with a reduced risk
of preterm birth, supplementation with omega-3 fatty
acids was not found to reduce the risk of preterm birth in a
large randomized trial of women with a prior preterm
spontaneous birth who received 17a-hydroxyprogesterone caproate (47, 48). Randomized placebo-controlled
trials of women taking vitamin C and vitamin E, supplemental calcium, and protein also have not been associated with a decreased risk of preterm birth (4953).

Clinical Considerations and

Recommendations
How should women with a previous sponta-

neous preterm birth be evaluated for risk of

subsequent preterm birth?

The evaluation of women with a prior spontaneous preterm birth should include obtaining a detailed medical
history, reviewing comprehensively aspects of all previous pregnancies, reviewing risk factors, and determining
their candidacy for prophylactic interventions, such as
progesterone supplementation, cervical cerclage, or both.
A comprehensive review of all previous pregnancies
is an important step in the evaluation of women at risk of
preterm birth because the most important historical risk
factor for recurrent preterm birth is a prior spontaneous
preterm birth, including births in the mid-to-late second
trimester (54). It can be difficult to differentiate spontaneous preterm birth from indicated preterm birth, but an
effort to establish this distinction should be an integral
part of history taking. The review of medical records and
placental pathology results can be helpful in this process.
Spontaneous preterm births are those in which the onset

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of parturition was spontaneous, regardless of whether

the process was later augmented. Rather than determining whether a prior preterm birth was spontaneous, it
may be easier first to exclude a prior preterm birth that
was obviously indicated (ie, initiated by the obstetric
care provider for a medical condition that threatened
maternal health, fetal health, or both).
How should the current pregnancy be man-

aged in a woman with a prior spontaneous

preterm delivery?

A woman with a singleton gestation and a prior spontaneous preterm singleton birth should be offered progesterone supplementation starting at 1624 weeks of
gestation to reduce the risk of recurrent spontaneous
preterm birth (5557) (Table 1). Whether such a woman
might additionally benefit from cervical cerclage placement also has been studied.
A multicenter, randomized trial examined the role
of serial transvaginal cervical length screening, with cerclage placement for short cervical length, among women
with singleton gestations and prior spontaneous preterm
births at less than 34 weeks of gestation, including some
women who received 17a-hydroxyprogesterone caproate
(58). Women in this trial underwent serial cervical length
screening once every 2 weeks, starting at 16 weeks of
gestation until 23 weeks of gestation. If the length of
the cervix was noted to be between 25 mm and 29 mm,
the screening frequency was increased to once a week.
If the cervical length was less than 25 mm, women were
randomized to undergo cerclage or not to undergo cerclage. The primary study outcome was preterm birth at
less than 35 weeks of gestation, for which no significant
difference was detected (relative risk [RR], 0.78; 95%
confidence interval [CI], 0.581.04) (58). However,
placement of a cerclage was associated with significant
reductions in deliveries before 24 weeks of gestation
(RR, 0.44; 95% CI, 0.210.92) and before 37 weeks of
gestation (RR, 0.75; 95% CI, 0.600.93) as well as in
perinatal death (RR, 0.54; 95% CI, 0.290.99) when
compared with the group that did not undergo cerclage
(58). In a planned secondary analysis, cerclage for cervical length less than 15 mm was associated with a significant decrease in preterm birth at less than 35 weeks
of gestation (RR, 0.23; 95% CI, 0.080.66) (58). Based
on the pooled results of five clinical trials, in a singleton
pregnancy with prior spontaneous preterm birth at less
than 34 weeks of gestation and cervical length less than
25 mm before 24 weeks of gestation, cerclage was associated with a 30% reduction in the risk of preterm birth
at less than 35 weeks of gestation (28% versus 41%; RR,
0.7; 95% CI, 0.550.89) and a 36% reduction in compos-

Prediction and Prevention of Preterm Birth

OBSTETRICS & GYNECOLOGY

Table 1. Selected Studies on Progesterone Supplementation for the Prevention of Preterm Delivery in Singleton Gestations
Study Dosage

Population

Meis, 2003*
17a-hydroxyprogesterone caproate (250 mg

weekly injections)

Women with a documented history of a spontaneous singleton preterm

birth at less than 37 weeks of gestation; cervical length not measured
at entry; treatment initiated between 16 weeks of gestation and 20
weeks of gestation and continued until 36 weeks of gestation or deliv-
ery, whichever occurred first

da Fonseca, 2003 Vaginal progesterone (100 mg daily)

High-risk women with a history of spontaneous singleton preterm birth;

treatment initiated at 24 weeks of gestation and continued until
34 weeks of gestation

OBrien, 2007
Vaginal progesterone (90 mg daily)

Women with a history of spontaneous preterm birth randomized

and treated; cervical length measured at entry (mean length, 37 mm);
treatment initiated between 18 weeks of gestation and 22 6/7 weeks
of gestation and continued until 37 weeks of gestation, occurrence of
premature rupture of membranes, or preterm delivery

Fonseca, 2007
Micronized progesterone gel capsules

(200 mg vaginally daily)

Asymptomatic women with a very short cervical length (15mm or less);

90% of the women had a singleton gestation and 85% had no prior
preterm delivery; treatment initiated at 24 weeks of gestation and con-
tinued until 34 weeks of gestation

Hassan, 2011||
Vaginal progesterone gel (90 mg daily)

Women with a singleton gestation with a previous preterm birth

between 20 weeks of gestation and 35 weeks of gestation; patients
were randomized between 20 weeks of gestation and 23 6/7 weeks of
gestation; treatment continued until 36 6/7 weeks of gestation, rupture
of membranes, or delivery, whichever occurred first.

Hassan, 2011||
Vaginal progesterone gel (90 mg daily)

Only women without prior preterm birth; patients were randomized

between 20 weeks of gestation and 23 6/7 weeks of gestation;
treatment continued until 36 6/7 weeks of gestation, rupture of
membranes, or delivery, whichever occurred first.

*Meis PJ, Klebanoff M, Thom E, Dombrowski MP, Sibai B, Moawad AH, et al. Prevention of recurrent preterm delivery by 17 alpha-hydroxyprogesterone caproate.
National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network [published erratum appears in N Engl J Med 2003;349:1299]. N
Engl J Med 2003;348:237985.
da Fonseca EB, Bittar RE, Carvalho MH, Zagaib M. Prophylactic administration of progesterone by vaginal suppository to reduce the incidence of spontaneous preterm
birth in women at increased risk: a randomized placebo-controlled double-blind study. Am J Obstet Gynecol 2003;188:41924.

OBrien JM, Adair CD, Lewis DF, Hall DR, Defranco EA, Fusey S, et al. Progesterone vaginal gel for the reduction of recurrent preterm birth: primary results from a
randomized, double-blind, placebo-controlled trial. Ultrasound Gynecol 2007;30:68796.

Fonseca EB, Celik E, Parra M, Singh M, Nicolaides KH. Progesterone and the risk of preterm birth among women with a short cervix. Fetal Medicine Foundation Second
Trimester Screening Group. N Engl J Med 2007;357:4629.

Hassan SS, Romero R, Vidyadhari D, Fusey S, Baxter JK, Khandelwal M, et al. Vaginal progesterone reduces the rate of preterm birth in women with a sonographic short
cervix: a multicenter, randomized, double-blind, placebo-controlled trial. PREGNANT Trial. Ultrasound Obstet Gynecol 2011;38:1831.
||

ite perinatal mortality and morbidity (16% versus 25%;

RR, 0.64; 95% CI, 0.450.91) (5860).
Although the single largest trial of cerclage for preterm birth prevention in high-risk women did not find
benefit for the primary study outcome, available evidence suggests that, in women with a current singleton
pregnancy, prior spontaneous preterm birth at less than
34 weeks of gestation and short cervical length (less
than 25 mm) before 24 weeks of gestation, cerclage
placement is associated with significant decreases in
preterm birth outcomes, offers perinatal benefits, and
may be considered in women with this combination of
history and ultrasound findings (58, 60). Insufficient

VOL. 120, NO. 4, OCTOBER 2012

evidence exists to assess whether progesterone and cerclage together have an additive effect in reducing the
risk of preterm birth in women at high risk for preterm
birth (61).
No evidence exists to support the addition of an alternative form of progesterone to the current progesterone
treatment (eg, adding a vaginal form to an intramuscular
form), if a short cervix is identified in a woman with a
prior preterm birth who is already receiving preventive
progesterone therapy. Also, there is no evidence to suggest that switching from treatment with intramuscular
progesterone to treatment with vaginal progesterone is
beneficial if a short cervix is identified.

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Prediction and Prevention of Preterm Birth

967

 Should a woman with a current singleton

pregnancy without a history of preterm birth

be screened for a risk of preterm birth?

In general, women in this clinical scenario are at a low

risk of preterm birth. However, if second trimester
transabdominal scanning of the lower uterine segment
suggests that the cervix may be short or have some other
abnormality, it is recommended that a subsequent transvaginal ultrasound examination be performed to better
visualize the cervix and establish its length (15). Until
recently, routine cervical length evaluation in women
at a low risk of preterm delivery was not advocated
because, like other factors associated with a potentially
higher preterm birth risk, no effective treatments were
available to reduce that risk. Recent randomized trials that investigated the use of vaginal progesterone in
women with a short cervix diagnosed through screening
have initiated consideration of whether the current standard for evaluating the cervix should be changed.
A European trial that enrolled women with a very
short cervical length (15 mm or less) demonstrated a
lower risk of preterm birth in those treated with vaginal
progesterone suppository, 200 mg daily, compared with
those who were treated with a placebo (62). In this study,
only 1.7% of the 24,640 women screened at 20 25 weeks
of gestation (median, 22 weeks of gestation) were found
to have a cervical length less than or equal to 15 mm and,
therefore, to be eligible for the trial.
In a subsequent randomized trial, the use of vaginal progesterone gel, 90 mg daily, was associated with
a decrease in spontaneous preterm birth at less than 33
weeks of gestation (9% versus 16%; RR, 0.55; 95% CI,
0.330.92) and a decrease in composite neonatal morbidity and mortality (8% versus 14%; RR, 0.57; 95% CI,
0.330.99) among asymptomatic women with a cervical
length of 1020 mm at 1923 6/7 weeks of gestation (16).
All the women in this study had singleton gestations, with
a 16% incidence of prior preterm birth. Analysis of only
women without prior preterm birth confirmed significant
benefit of progesterone in preventing preterm birth before
33 weeks of gestation in this study (16). Even taking
into account the large number of women needed to be
screened to identify those at risk, recent decision and
economic analyses concluded that universal ultrasound
screening for short cervical length and treatment with
vaginal progesterone was cost-effective (63, 64).
Proponents of universal cervical length screening of
women without a prior preterm birth cite the following
points in support of this practice: it has the potential to
reduce the preterm birth rate; high quality evidence exists
to support efficacy of treatment for positive test results
(ie, cervical length of 20 mm or less); and it is cost effec-

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Practice Bulletin

tive, safe, accepted by patients, and widely available.

Opponents of this approach raise the following concerns:
quality assurance of the screening test; lack of availability of screening and of patient access to qualified imaging
centers in some areas; and the potential for patients to
receive unnecessary or unproven interventions.
The American College of Obstetricians and Gynecologists recognizes that both sides of this debate raise
valid issues. Although this document does not mandate
universal cervical length screening in women without a
prior preterm birth, this screening strategy may be considered. Practitioners who decide to implement universal
cervical length screening should follow one of the protocols for transvaginal measurement of cervical length
from the clinical trials on this subject. Protocol citations
are listed in Table 1.
What interventions have been shown to be

beneficial for reducing the risk of preterm

birth in women who do not have a history of
preterm birth but who are found to have a
short cervical length?

Cerclage and progesterone are the two interventions that

have been evaluated in randomized trials for effectiveness in preventing preterm birth in women with singleton gestations without a prior preterm birth (Fig. 1).
Vaginal progesterone has been studied as a management option to reduce the risk of preterm birth in asymptomatic women with singleton gestations without prior
preterm birth with a very short cervical length, defined
as less than or equal to 20 mm at up to 24 weeks of gestation. In a randomized placebo-controlled trial, treatment
with vaginal micronized progesterone, 200 mg daily,
was associated with a 44% decrease in spontaneous preterm birth at less than 34 weeks of gestation among
asymptomatic women with a cervical length of 15 mm or
less at 2025 weeks of gestation (19% versus 34%; RR,
0.56; 95% CI, 0.360.86) (62). In this study, 90% of the
women had a singleton gestation, and 85% had no prior
preterm birth (62).
In another recent randomized placebo-controlled
trial, treatment with vaginal progesterone gel, 90 mg
daily, was associated with a 45% decrease in spontaneous preterm birth at less than 33 weeks of gestation (9%
versus 16%; RR, 0.55; 95% CI, 0.330.92) and a 43%
decrease in composite neonatal morbidity and mortality
(8% versus 14%; RR, 0.57; 95% CI, 0.330.99) among
asymptomatic women with a cervical length of 1020.9
mm at 1923 6/7 weeks of gestation (16). All the women
in this study had singleton gestations, with a 16% incidence of prior preterm birth. Analysis of only women
without prior preterm birth confirmed significant benefit

Prediction and Prevention of Preterm Birth

OBSTETRICS & GYNECOLOGY

Short cervix identified with

transvaginal ultrasonography

Singleton gestation

No prior spontaneous
preterm birth

Vaginal progesterone
supplementation
should be offered if
cervical length is
20 mm or less
before or at
24 weeks of gestation

Multiple gestation

Prior spontaneous
preterm birth and
receiving progesterone
supplementation since
16 weeks of gestation

No intervention has
been shown to
improve outcomes

Cerclage should be
considered if cervical
length is less than
25 mm before
24 weeks of gestation
and prior preterm birth
occurred at less than
34 weeks of gestation

Fig. 1. Algorithm for the management of short cervical length in the second trimester.

of treatment with progesterone in preventing preterm

birth before 33 weeks of gestation in this study (16).
Therefore, vaginal progesterone is recommended as a
management option to reduce the risk of preterm birth in
asymptomatic women with a singleton gestation without
a prior preterm birth with an incidentally identified very
short cervical length less than or equal to 20 mm before
or at 24 weeks of gestation.
In contrast, for women in this otherwise low-risk
population, cerclage placement in women with a cervical length less than 25 mm detected between 16 weeks
of gestation and 24 weeks of gestation has not been
associated with a significant reduction in preterm birth
at less than 35 weeks of gestation [RR, 0.76; 95% CI,
0.521.15] (59). Even cerclage placement for detection
of a cervical length of 15 mm or less in women at 2224
weeks of gestation has not been shown to significantly
decrease the rate of preterm birth (at less than 33 weeks
of gestation) (RR, 0.84; 95% CI, 0.541.31) (65).
In one trial of women with an incidentally diagnosed short cervix (less than or equal to 25 mm at 1822
weeks of gestation), open-label randomization to placement of a cervical pessary or expectant management (no
pessary) was studied (66). In this trial of 385 women,
the rate of spontaneous delivery at less than 34 weeks
of gestation was significantly lower in the pessary group
than in the no pessary group (6% compared with 27%;
OR, 0.18; 95% CI, 0.080.37). If the results of this small
trial are validated, cervical pessary placement may have

VOL. 120, NO. 4, OCTOBER 2012

additional benefit for prevention of preterm birth in otherwise low-risk women with a short cervix.
Does cerclage placement or progesterone

treatment decrease the risk of preterm birth

in women with multiple gestations?

Available data regarding the efficacy of cerclage placement, progesterone supplementation, or both for the
reduction of preterm birth risk in women with multiple
gestations with a short cervical length with or without a
prior preterm birth do not support their use (67). Cerclage
may increase the risk of preterm birth in women with a
twin pregnancy and ultrasonographically detected cervical length less than 25 mm and is not recommended. In
a meta-analysis of randomized trials, cerclage performed
in women with a twin pregnancy and a cervical length
less than 25 mm was actually associated with a significant
twofold increase in the rate of preterm birth (RR, 2.2; 95%
CI, 1.2-4) (59). Progesterone treatment does not reduce
the incidence of preterm birth in women with twin or
triplet gestations and, therefore, is not recommended as
an intervention to prevent preterm birth in women with
multiple gestations (6872). Currently, no data are available regarding the efficacy of any other interventions to
reduce the risk of preterm birth in women with multiple
gestations and a short cervix, and the use of any such
alternative measures cannot be recommended outside of
formal clinical trials.

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969

Summary of
Recommendations and
Conclusions
Recommendations based on good and consistent
scientific evidence (Level A):
A woman with a singleton gestation and a prior
spontaneous preterm singleton birth should be
offered progesterone supplementation starting at
1624 weeks of gestation, regardless of transvaginal ultrasound cervical length, to reduce the risk of
recurrent spontaneous preterm birth.
Vaginal progesterone is recommended as a management option to reduce the risk of preterm birth in
asymptomatic women with a singleton gestation
without a prior preterm birth with an incidentally
identified very short cervical length less than or
equal to 20 mm before or at 24 weeks of gestation.
Tests, such as fetal fibronectin screening, bacterial
vaginosis testing, and home uterine activity monitoring, are not recommended as screening strategies.
Progesterone treatment does not reduce the incidence of preterm birth in women with twin or triplet
gestations and, therefore, is not recommended as an
intervention to prevent preterm birth in women with
multiple gestations.

length from he clinical trials on this subject. Protocol

citations are listed in Table 1.

Proposed Performance
Measure
Percentage of women with a prior spontaneous preterm
birth who are offered progesterone supplementation

References
1. Martin JA, Hamilton BE, Sutton PD, Ventura SJ, Mathews
TJ, Osterman MJ. Births: final data for 2008. Natl Vital
Stat Rep 2010;59:172. (Level II-3)
2. Goldenberg RL, Culhane JF, Iams JD, Romero R.
Epidemiology and causes of preterm birth. Lancet 2008;
371:7584. (Level III)
3. Wood NS, Marlow N, Costeloe K, Gibson AT, Wilkinson
AR. Neurologic and developmental disability after extremely
preterm birth. EPICure Study Group. N Engl J Med 2000;
343:37884. (Level II-2)
4. Preterm singleton births--United States, 1989-1996. Centers
for Disease Control and Prevention (CDC). MMWR Morb
Mortal Wkly Rep 1999;48:1859. (Level II-3)
5. Simhan NH, Iams JD, Romero R. Preterm birth. In:
Gabbe SG, Niebyl JR, Simpson JL, Landon MB, Galan
HL, Jauniaux ER, et al, editors. Obstetrics: normal and
problem pregnancies. 6th ed. Philadelphia (PA): Elsevier
Saunders; 2012. p. 62856. (Level III)

Recommendations based on limited or inconsistent scientific evidence (Level B):

6. Martin JA, Hamilton BE, Ventura SJ, Osterman MJ,

Kirmeyer S, Mathews TJ, et al. Births: final data for 2009.
Natl Vital Stat Rep 2011;60:171. (Level II-3)

Although this document does not mandate universal

cervical length screening in women without a prior
preterm birth, this screening strategy may be considered.

7. Clark SL, Miller DD, Belfort MA, Dildy GA, Frye DK,
Meyers JA. Neonatal and maternal outcomes associated
with elective term delivery. Am J Obstet Gynecol 2009;200:
156.e14. (Level II-3)

Insufficient evidence exists to assess if progesterone

and cerclage together have an additive effect in
reducing the risk of preterm birth in women at high
risk for preterm birth.
Cerclage may increase the risk of preterm birth in
women with a twin pregnancy and an ultrasonographically detected cervical length less than 25 mm
and is not recommended.

8. Fleischman AR, Oinuma M, Clark SL. Rethinking the definition of term pregnancy. Obstet Gynecol 2010;116:
1369. (Level III)
9. Spong CY. Prediction and prevention of recurrent spontaneous preterm birth. Obstet Gynecol 2007;110:40515.
(Level III)
10. McManemy J, Cooke E, Amon E, Leet T. Recurrence risk
for preterm delivery. Am J Obstet Gynecol 2007;196:576.
e16; discussion 576.e67. (Level II-3)

Recommendations based primarily on consensus

and expert opinion (Level C):

11. Bakketeig LS, Hoffman HJ. Epidemiology of preterm

birth: results from a longitudinal study of births in Norway.
In: Elder MG, Hendricks CH, editors. Preterm labor.
Boston (MA): Butterworths; 1981. p. 1746. (Level III)

Practitioners who decide to implement universal

cervical length screening should follow one of the
protocols for transvaginal measurement of cervical

12. Menard MK, Newman RB, Keenan A, Ebeling M. Prognostic significance of prior preterm twin delivery on subsequent singleton pregnancy. Am J Obstet Gynecol 1996;
174:142932. (Level II-3)

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The MEDLINE database, the Cochrane Library, and the

American College of Obstetricians and Gynecologists
own internal resources and documents were used to con
duct a literature search to locate relevant articles published
between January 1990 and March 2012. The search was
re
strict
ed to ar
ti
cles pub
lished in the English lan
guage.
Priority was given to articles reporting results of original
research, although review articles and commentaries also
were consulted. Abstracts of research presented at sympo
sia and scientific conferences were not considered adequate
for inclusion in this document. Guidelines published by
organizations or institutions such as the National Institutes
of Health and the American College of Obstetricians and
Gynecologists were reviewed, and additional studies were
located by reviewing bibliographies of identified articles.
When reliable research was not available, expert opinions
from obstetriciangynecologists were used.
Studies were reviewed and evaluated for quality according
to the method outlined by the U.S. Preventive Services
Task Force:
I Evidence obtained from at least one prop
er
ly
designed randomized controlled trial.
II-1 Evidence obtained from well-designed con
trolled
trials without randomization.
II-2 Evidence obtained from well-designed co
hort or
casecontrol analytic studies, preferably from more
than one center or research group.
II-3 Evidence obtained from multiple time series with or
without the intervention. Dramatic results in uncon
trolled experiments also could be regarded as this
type of evidence.
III Opinions of respected authorities, based on clinical
experience, descriptive studies, or reports of expert
committees.
Based on the highest level of evidence found in the data,
recommendations are provided and graded according to the
following categories:
Level ARecommendations are based on good and con
sistent scientific evidence.
Level BRecommendations are based on limited or incon
sistent scientific evidence.
Level CRecommendations are based primarily on con
sensus and expert opinion.
Copyright October 2012 by the American College of Obste
tricians and Gynecologists. All rights reserved. No part of this
publication may be reproduced, stored in a retrieval system,
posted on the Internet, or transmitted, in any form or by any
means, electronic, mechanical, photocopying, recording, or
otherwise, without prior written permission from the publisher.
Requests for authorization to make photocopies should be
directed to Copyright Clearance Center, 222 Rosewood Drive,
Danvers, MA 01923, (978) 750-8400.
The American College of Obstetricians and Gynecologists
409 12th Street, SW, PO Box 96920, Washington, DC 20090-6920
Prediction and prevention of preterm birth. Practice Bulletin No. 130.
American College of Obstetricians and Gynecologists. Obstet Gynecol
2012;120:96473.

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