Methods

Study Design: "randomised trial"

Duration of the study: 3.5 years

Participants

Setting: Women's Hospital, Los Angeles County‐ University of Southern California Medical Center.

Inclusion criteria: "women diagnosed before pregnancy with insulin‐dependent diabetes mellitus or non‐insulin‐dependent diabetes mellitus without vascular complications or with gestational diabetes requiring insulin treatment during pregnancy, and with good metabolic control of blood glucose levels ... 38 completed weeks gestation (266 days), good compliance with clinical appointments and home blood glucose monitoring, no abnormalities in the twice weekly antepartum assessment with nonstress testing and amniotic fluid volume measurement performed from 34 weeks onward, singleton gestation and cephalic presentation, clinical and ultrasonographic estimation of fetal weight <3800gm at 38 completed weeks with no evidence of intrauterine growth retardation, no other medical or obstetric complications, a candidate for trial of vaginal delivery (no more than 2 previous C‐sections)".

Interventions

Planned birth: N = 100 women, "labour was induced with iv oxytocin .... in women with favourable Bishops Score (<4), unscarred uteri and normal amniotic fluid indexes (>5.0cms), up to 3 applications of vaginal prostaglandin (3 mg) were used for cervical ripening before oxytocin treatment".

Expectant approach: N = 100 women, "expectant management consisted of daily split dose insulin therapy and home blood glucose monitoring, weekly antenatal clinic visits, and twice‐weekly antepartum testing". Induction of labour indicated by: "suspected fetal distress .... preeclampsia, maternal hyperglycaemia, estimated fetal weight > 4200gm, 42 weeks gestation".

Outcomes

Outcomes considered relevant to this review: mode of delivery — vaginal delivery, caesarean delivery; infant birthweight — macrosomia, large‐for‐gestational age; infant outcome — shoulder dystocia, birth trauma (bone fracture, Erbs palsy), hypoglycaemia, mortality.

Notes

Funding: not known

Trial authors declaration of Interest: none declared

The authors were contacted on: 10th Jan 2017, to obtain data specifically related to pregnant women with pre‐existing diabetes in both the experimental and control groups.