The Balloon Project for Birth Induction

NCT01255839 | Completed Phase 4

• 1 other identifier: H-KA-01177-M
• Study Type: interventional
• Target: 825
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

double-balloon; balloon catheter; prostaglandin; minprostin; induction of labour; fetal outcome

Outcome Measures

Primary Outcomes (1)

• success of induction of labour, duration of birth and fetal outcome

  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) .

  at birth

Secondary Outcomes (1)

• the results for various subgroups, i.e. primipara/multipara, gemelli, vaginal birth after caesarean, preterm birth and intra uterine growth restriction

  at birth

Study Arms (2)

Double-balloon

ACTIVE COMPARATOR

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.

Device: Double Balloon

Prostglandin E2

ACTIVE COMPARATOR

The prostaglandin 2 minprostin (3mg) was applied vaginally

Drug: Minprostin

Interventions

Double Balloon DEVICE

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.

Double-balloon

Minprostin DRUG

The prostaglandin 2 minprostin (3mg) was applied vaginally

Prostglandin E2

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Spontaneous labour or rupture of membranes
• placenta previa
• acute fetal distress
• specific infections vagina/cervix (GBS, condyloma, acute herpes)
• asthma
• glaucoma
• allergy to latex

Sponsors & Collaborators

• Glostrup University Hospital, Copenhagen: lead

Study Sites (1)

Glostrup University Hospital

Glostrup Municipality, Glostrup, 2600, Denmark

Location

MeSH Terms

Interventions

Double-Balloon Enteroscopy; dinoprost tromethamine

Intervention Hierarchy (Ancestors)

Balloon Enteroscopy; Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 6, 2010
• First Posted: December 8, 2010
• Study Start: December 1, 2002
• Primary Completion: September 1, 2005
• Study Completion: December 1, 2010
• Last Updated: December 8, 2010

Record last verified: 2002-01

Locations

DK (1)