Labor Induction versus Expectant Management

in Low-Risk
Nulliparous Women

-Dr. Namrata Dhital

1st Yr ObGyn Resident
CMC-TH
 Authors:
William A. Grobman, M.D., Madeline M. Rice, Ph.D.,
Uma M. Reddy, M.D., M.P.H., Alan T.N. Tita, M.D.,
Ph.D.,Robert M. Silver, M.D., Gail Mallett, R.N., M.S.,
C.C.R.C., Kim Hill, R.N., B.S.N., Elizabeth A. Thom,
Ph.D.,Yasser Y. El‑Sayed, M.D., Annette Perez‑Delboy,
M.D., Dwight J. Rouse, M.D., George R. Saade, M.D.,Kim
A. Boggess, M.D., Suneet P. Chauhan, M.D., Jay D. Iams,
M.D., Edward K. Chien, M.D., Brian M. Casey,
M.D.,Ronald S. Gibbs, M.D., Sindhu K. Srinivas, M.D.,
M.S.C.E., Geeta K. Swamy, M.D., Hyagriv N. Simhan,
M.D.,and George A. Macones, M.D., M.S.C.E
 Contents
• Introduction
• Methodology
• Results
• Discussion
• Conclusion
• Critical analysis
 Why did I choose this article?
• To have a better perinatal outcome
• To avoid maternal morbidity in present
pregnancy
• To avoid risk to the fetus in the present
pregnancy
 Introduction
• Recommendations regarding the timing of
delivery are founded on a balancing of
maternal and perinatal risks
• Delivery before 39 weeks 0 days of gestation
without medical indication is associated with
worse perinatal outcomes than delivery at full
term
• For women who are at 41 weeks of gestation
or later, delivery has been recommended
because of increasing perinatal risks
• When gestation is between 39 weeks 0 days
and 40 weeks 6 days, common practice has
been to avoid elective labor induction because
of a lack of evidence of perinatal benefit and
concern about a higher frequency of cesarean
delivery and other possible adverse maternal
outcomes, particularly among nulliparous
women.
• However, these conclusions were derived
largely from observational studies in which
labor induction was compared with
spontaneous labor.
• Such a comparison provides little insight into
clinical management, because spontaneous
labor is not a certain alternative to labor
induction.
• Most observational studies that have used the
clinically relevant comparator of expectant
management have not shown a higher risk of
adverse outcomes with labor induction
• Instead, some of these studies have shown
that induction of labor resulted in a lower
frequency of cesarean delivery and more
favorable perinatal outcomes than expectant
management
• The ARRIVE trial (A Randomized Trial of
Induction Versus Expectant Management) was
designed to test the hypothesis that elective
induction of labor at 39 weeks would result in
a lower risk of a composite outcome of
perinatal death or severe neonatal
complications than expectant management
among low-risk nulliparous women.
METHODS
• In this multicenter trial, low-risk nulliparous women
randomly assigned who were at 38 weeks 0 days to 38
weeks 6 days of gestation to labor induction at 39
weeks 0 days to 39 weeks 4 days or to expectant
management.
• The primary outcome was a composite of perinatal
death or severe neonatal complications
• The principal secondary outcome was cesarean
delivery.
 Methodology
• Multicenter, randomized, controlled, parallel-
group, unmasked trial
• Conducted at 41 hospitals participating in the
Maternal–Fetal Medicine Units Network of the
Eunice Kennedy Shriver National Institute of
Child Health and Human Development.
• The protocol was approved by the institutional
review board at each hospital before participant
enrollment.
• Written informed consent was obtained from
all participants before randomization.
• An independent data and safety monitoring
committee monitored the trial.
• The authors vouched for the accuracy and
completeness of the data and for the fidelity
of the trial to the protocol.
 Inclusion criteria:

• Low-risk nulliparous women who were at 34

weeks 0 days to 38 weeks 6 days of gestation
with a live singleton fetus that was in a vertex
presentation, who had no contraindication to
vaginal delivery, and who had no cesarean
delivery planned were screened for eligibility.
• Reliable information on the length of gestation
was also a criterion for enrollment;
• Low risk was defined as the absence of any
condition considered to be a maternal or fetal
indication for delivery before 40 weeks 5 days
(e.g., hypertensive disorders of pregnancy or
suspected fetalgrowth restriction)
 Randomization and Management Strategy

• Women who consented to participate were

assessed again between 38 weeks 0 days and
38 weeks 6 days of gestation to ensure that
they did not have new indications for delivery
that would make them ineligible for the trial.
• Women who were in labor or had premature
rupture of membranes or vaginal bleeding at
this time were considered to be ineligible.
Women who met the inclusion criteria were
randomly assigned in a 1:1 ratio to either
labor induction or expectant management.
• The cervix was examined before labor, from 72
hours before to 24 hours after randomization,
to assess dilation, effacement, and station of
the fetus to determine a modified Bishop
score (scores range from 0 to 12, with lower
scores associated with a higher chance of
cesarean delivery)
• Women in the induction group were assigned
to undergo induction of labor at 39 weeks 0
days to 39 weeks 4 days.
• Women in the expectant management group
were asked to forego elective delivery before
40 weeks 5 days and to have delivery initiated
no later than 42 weeks 2 days.
• A specific induction protocol was not
mandated for women who underwent
induction in either group.
 Characteristics of the Participants

• From March 2014 through August 2017, a

total of 50,581 women underwent screening
for eligibility.
• Of the 22,533 eligible women, 6106 (27%)
provided written informed consent and
underwent randomization: 3062 were
assigned to the induction group, and 3044 to
the expectant management group .
• At the time of randomization, 63% of the
participants had an unfavorable modified
Bishop score (i.e., a score <5).
• The two groups were similar at baseline,
except that fewer women in the induction
group than in the expectant-management
group had a previous pregnancy loss (22.8%
vs. 25.6%, P = 0.01) .
• The obstetrical provider at the time of
admission for delivery was a physician for 94%
of women and a midwife for 6%.
 Adherence

• Three women in the induction group and 7 in

the expectant-management group were lost to
follow up or withdrew consent.
• In the case of 184 women (6.0%) in the
induction group and 140 (4.6%) in the
expectant-management group, the
management was not consistent with the
protocol of the assigned strategy
• Women in the induction group had a shorter
median time from randomization to delivery
than women in the expectant-management
group (7 days [interquartile range, 5 to 9] vs.
12 days [interquartile range, 7 to 16], P<0.001)
• In addition, women in the induction group
underwent delivery at a significantly earlier
median gestational age (39.3 weeks
[interquartile range, 39.1 to 39.6] vs. 40.0
weeks [interquartile range, 39.3 to 40.7],
P<0.001) and had neonates with significantly
lower median birth weights (3300 g
[interquartile range, 3040 to 3565] vs. 3380 g
[interquartile range, 3110 to 3650], P<0.001).
 Discussion
• In this randomized trial involving low-risk
nulliparous women, no significant difference
was found in the frequency of the primary
outcome (a composite of adverse perinatal
outcomes) between women randomly
assigned to labor induction at 39 weeks of
gestation and women assigned to expectant
management.
• Nevertheless, the relative risk was 20% lower
in the induction group than in the expectant-
management group, and the corresponding
95% confidence interval suggests that labor
induction is probably not associated with a
higher risk of adverse perinatal outcomes than
expectant management, and it may be
associated with as much as a 36% lower risk
than expectant management.
• Labor induction also resulted in a significantly
lower frequency of cesarean delivery and
hypertensive disorders of pregnancy than
expectant management, even after post hoc
adjustment for multiplicity.
• This data suggests that 1 cesarean delivery may
be avoided for every 28 deliveries among low-
risk nulliparous women who plan to undergo
elective induction of labor at 39 weeks.
• These findings contradict the conclusions of
multiple observational studies that have
suggested that labor induction is associated
with an increased risk of adverse maternal and
perinatal outcomes.
• These studies, however, compared women who
underwent labor induction with those who had
spontaneous labor, which is not a comparison
that is useful to guide clinical decision making.
• We found no significant difference in the magnitude
of effect with respect to the primary perinatal
outcome or cesarean delivery according to whether
a woman had an unfavorable modified Bishop score
at randomization.
• This finding may seem unexpected, given the
consistent evidence that women with an
unfavorable Bishop score have a higher chance of
cesarean delivery when labor is induced than
women with a favorable score.
 Limitations
• Masking was not feasible, ascertainment bias
was possible.
• Despite its size, the trial was not powered to
detect differences in infrequent outcomes,
and most individual adverse perinatal
outcomes were relatively uncommon.
• It is unclear whether results are broadly
generalizable; however, the inclusion of both
university and community hospitals
throughout the United States and of a variety
of types of obstetrical providers, as well as the
absence of a single protocol for induction or
labor management, suggests that results are
probably generalizable to similar centers.
• Cost-effectiveness of labor induction in low-
risk nulliparous women at 39 weeks needs to
be evaluated in further analyses.
 Summary
• Elective labor induction at 39 weeks of
gestation did not result in a greater frequency
of perinatal adverse outcomes than expectant
management and resulted in fewer instances
of cesarean delivery.
• These results suggest that policies aimed at
the avoidance of elective labor induction
among low-risk nulliparous women at 39
weeks of gestation are unlikely to reduce the
rate of cesarean delivery on a population
level; the trial provides information that can
be incorporated into discussions that rely on
principles of shared decision making.
RESULTS
• A total of 3062 women were assigned to labor
induction, and 3044 were assigned to expectant
management.
• The primary outcome occurred in 4.3% of
neonates in the induction group and in 5.4% in
the expectant-management group (relative risk,
0.80; 95% confidence interval [CI], 0.64 to 1.00).
• The frequency of cesarean delivery was
significantly lower in the induction group than
in the expectant-management group (18.6%
vs. 22.2%; relative risk, 0.84; 95% CI, 0.76 to
0.93).
CONCLUSIONS
• Induction of labor at 39 weeks in low-risk
nulliparous women did not result in a
significantly lower frequency of a composite
adverse perinatal outcome, but it did result in
a significantly lower frequency of cesarean
delivery
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