What is the issue?
The aim of this Cochrane review was to find out if planning an elective birth at or near the term of pregnancy, compared to waiting for labour to start spontaneously, has an impact on the health of women with gestational diabetes and the health of their babies. Planned early birth means either induction of labour or caesarean birth, and 'at or near term' means 37 to 40 weeks' gestation. To answer this question, we collected and analysed all relevant studies conducted up to August 2017.
Why is this important?
Women with gestational diabetes (glucose intolerance arising during pregnancy) and their babies are at increased risk of health complications (e.g. high blood pressure, bigger babies). Because of the complications sometimes associated with birthing a big baby, many clinicians have recommended that women with gestational diabetes have an elective birth (generally an induction of labour) at or near term (37 to 40 weeks' gestation) rather than waiting for labour to start spontaneously, or until 41 weeks' gestation if all is well. Induction has disadvantages of increasing the incidence of forceps or ventouse births, and women often find it difficult to cope with an induced labour. Caesarean section is a major operation which can lead to blood loss, infections and increased chance of problems with subsequent births. Early birth can increase the chance of breathing problems for babies. It is important to know which approach to birth has a better impact on the health outcomes of women with gestational diabetes and their babies.
What evidence did we find?
Our search identified one trial involving 425 women and their babies. In this trial, 214 women had an induction of their labour at term, the other 211 women waited for a spontaneous onset of their labour.
The findings of this trial highlighted no clear difference between the babies of women in either group in relation to the number of large babies, baby's shoulder getting stuck during birth or babies with breathing problems, low blood sugar and admission to a neonatal intensive care unit. No baby in the trial experienced birth trauma. In the group of women whose labour was induced, there were more incidences of jaundice in the babies. There was no clear difference between women in either group in relation to serious health problems for women, caesarean section, instrumental vaginal birth, postpartum haemorrhage, admission to an intensive care unit and intact perineum. There were no reports in either group of maternal deaths. It should be noted that most of the evidence was found to be of very low quality.
The following outcomes were not reported: postnatal depression, maternal satisfaction, length of postnatal stay (mother), babies with high blood acid, bleeding in the baby's brain, other brain problems for the babies, babies small-for-gestational age and length of baby's postnatal stay.
What does this mean?
There is insufficient evidence to clearly identify if there are differences in health outcomes for women with gestational diabetes and their babies when elective birth is undertaken compared to waiting for labour to start spontaneously or until 41 weeks' gestation if all is well. More research is needed to answer this question.
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.
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).
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.
We searched Cochrane Pregnancy and Childbirth’s Trials Register, ClinicalTrials.gov and the WHO International Clinical Trials Registry Platform (ICTRP) (15 August 2017), and reference lists of retrieved studies.
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.
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.
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.