posted on 2018-03-15, 09:41authored byLinda M. Biesty, Aoife M. Egan, Fidelma Dunne, Eugene Dempsey, Pauline MeskellPauline Meskell, Valerie Smith, Meabh G. Ni Bhuinneain, Declan Devane
Background
Gestational diabetes is a type of diabetes that occurs during pregnancy. Women with gestational diabetes are more likely to experience
adverse health outcomes such as pre-eclampsia or polyhydramnios (excess amniotic fluid). Their babies are also more likely to have
health complications such as macrosomia (birthweight > 4000 g) and being large-for-gestational age (birthweight above the 90th
percentile for gestational age). Current clinical guidelines support elective birth, at or near term in women with gestational diabetes to
minimise perinatal complications, especially those related to macrosomia.
This review replaces a review previously published in 2001 that included “diabetic pregnant women”, which has now been split into
two reviews. This current review focuses on pregnant women with gestational diabetes and a sister review focuses on women with pre-existing
diabetes (Type 1 or Type 2).
Objectives
To assess the effect of planned birth (either by induction of labour or caesarean birth), at or near term (37 to 40 weeks’ gestation)
compared with an expectant approach for improving health outcomes for women with gestational diabetes and their infants. The
primary outcomes relate to maternal and perinatal mortality and morbidity.
Search methods
We searched Cochrane Pregnancy and Childbirth’s Trials Register, Clinical Trials.gov and the WHO International Clinical Trials Registry
Platform (ICTRP) (15 August 2017), and reference lists of retrieved studies.
Selection criteria
We included randomised trials comparing planned birth, at or near term (37 to 40 weeks’ gestation), with an expectant approach, for
women with gestational diabetes. Cluster-randomised and non-randomised trials (e.g. quasi-randomised trials using alternate allocation)
were also eligible for inclusion but none were identified.
Data collection and analysis
Two of the review authors independently assessed study eligibility, extracted data and assessed the risk of bias of the included study.
The quality of the evidence was assessed using the GRADE approach.
Main results
The findings of this review are based on a single trial involving 425 women with gestational diabetes. The trial compared induction
of labour with expectant management (waiting for the spontaneous onset of labour in the absence of any maternal or fetal issues that
may necessitate birth) in pregnant women with gestational diabetes at term. We assessed the overall risk of bias as being low for most
domains, apart from performance, detection and attrition bias (for outcome perineum intact), which we assessed as being at high risk.
It was an open-label trial, and women and healthcare professionals were not blinded.
There were no clear differences between women randomised to induction of labour and women randomised to expectant management
for maternal mortality or serious maternal morbidity (risk ratio (RR) 1.48, 95% confidence interval (CI) 0.25 to 8.76, one trial, 425
women); caesarean section (RR 1.06, 95% CI 0.64 to 1.77, one trial, 425 women); or instrumental vaginal birth (RR 0.81, 95% CI
0.45 to 1.46, one trial, 425 women). For the primary outcome of maternal mortality or serious maternal morbidity, there were no deaths
in either group and serious maternal morbidity related to admissions to intensive care unit. The quality of the evidence contributing
to these outcomes was assessed as very low, mainly due to the study having high risk of bias for some domains and because of the
imprecision of effect estimates.
In relation to primary neonatal outcomes, there were no perinatal deaths in either group. The quality of evidence for this outcome
was judged as very low, mainly due to high risk of bias and imprecision of effect estimates. There were no clear differences in infant
outcomes between women randomised to induction of labour and women randomised to expectant management: shoulder dystocia
(RR 2.96, 95% CI 0.31 to 28.21, one trial, 425 infants, very low-quality evidence); large-for-gestational age (RR 0.53, 95% CI 0.28
to 1.02, one trial, 425 infants, low-quality evidence).
There were no clear differences between women randomised to induction of labour and women randomised to expectant management
for postpartum haemorrhage (RR 1.17, 95% CI 0.53 to 2.54, one trial, 425 women); admission to intensive care unit (RR 1.48,
95% CI 0.25 to 8.76, one trial, 425 women); and intact perineum (RR 1.02, 95% CI 0.73 to 1.43, one trial, 425 women). No
infant experienced a birth trauma, therefore, we could not draw conclusions about the effect of the intervention on the outcomes of
brachial plexus injury and bone fracture at birth. Infants of women in the induction-of-labour group had higher incidences of neonatal
hyperbilirubinaemia (jaundice) when compared to infants of women in the expectant-management group (RR 2.46, 95% CI 1.11 to
5.46, one trial, 425 women).
We found no data on the following prespecified outcomes of this review: postnatal depression, maternal satisfaction, length of postnatal
stay (mother), acidaemia, intracranial haemorrhage, hypoxia ischaemic encephalopathy, small-for-gestational age, length of postnatal
stay (baby) and cost.
The authors of this trial acknowledge that it is underpowered for their primary outcome of caesarean section. The authors of the trial
and of this review note that the CIs demonstrate a wide range, therefore making it inappropriate to draw definite conclusions.
Authors’ conclusions
There is limited evidence to inform implications for practice. The available data are not of high quality and lack power to detect possible
important differences in either benefit or harm. There is an urgent need for high-quality trials evaluating the effectiveness of planned
birth at or near term gestation for women with gestational diabetes compared with an expectant approach.
History
Publication
Cochrane Database of Systematic Reviews;Issue 1. Art. No.: CD012910
Publisher
Wiley and Sons Ltd., Cochrane Collaboration
Note
peer-reviewed
Other Funding information
The Institute for Maternal & Child Health, IRCCS, Burlo Garofolo