The Balloon Project for Birth Induction

• Status: Completed
• Trial end date: 2010-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

The use of prostaglandin E2 (PGE2) for induction of labour in women with unfavourable cervices is well-established1. There are, however, potential side effects to prostaglandins, in particular the risk of uterine hypertonicity which may affect fetal outcome. In theory a mechanical ripening based on dilatation of the cervix as well as induction of production of endogenous prostaglandin has potentially less influence on the fetal outcome but a Cochrane review from 2001 scrutinized studies on mechanical ripening versus placebo/no treatment or prostaglandin E2. They conclude there is insufficient data to evaluate the effectiveness in terms of likelihood of vaginal delivery in 24 hours, and emphasise the need for large sample size studies and substantive outcomes. Two later randomised studies compared mechanical ripening to PGE2 and found discrepant results regarding time from induction to delivery.

The primary purpose of the present study was in a randomized design to compare the efficacy of double-balloon catheter versus vaginal PGE2 (minprostin 3 mg) on induction of labour, duration of birth and fetal outcome. Secondary analyses were to evaluate the results for various subgroups, i.e. primipara/multipara, gemelli, vaginal birth after caesarean, preterm birth and intra uterine growth restriction.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Glostrup University Hospital, Copenhagen

Criteria

Inclusion Criteria:

• pregnancies with intact fetal membranes

• vertex position

• unripe cervix Bishop score < 6)

• usual indications for induction of labour, i.e. prolonged pregnancy, pre-eclampsia/ hyper-tension, placental insufficiency, diabetes mellitus and twins

Exclusion Criteria:

• Spontaneous labour or rupture of membranes

• placenta previa

• acute fetal distress

• specific infections vagina/cervix (GBS, condyloma, acute herpes)

• asthma

• glaucoma

• allergy to latex