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The Balloon Project for Birth Induction

NCT01255839 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 825

Last updated 2010-12-08

No results posted yet for this study

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.

Conditions

  • Induction Time
  • Apgar Score
  • Admission to Neonatal Unit
  • Vaginal Delivery
  • Caesarean Section

Interventions

DEVICE

Double Balloon

The Double Balloon Catheter was applied (Atad 5) with 80 ml NaCl installed intrauterine above the intern orificium and 80 ml below in cervix/vagina.

DRUG

Minprostin

The prostaglandin 2 minprostin (3mg) was applied vaginally

Sponsors & Collaborators

  • Glostrup University Hospital, Copenhagen

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-12-31
Primary Completion
2005-09-30
Completion
2010-12-31

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01255839 on ClinicalTrials.gov