Foley Catheter Versus Vaginal Misoprostol for Cervical Ripening and Induction of Labor

Not Applicable

Completed

• Conditions: Pregnancy, Prolonged; Pre Eclampsia; Oligohydramnios
• Interventions: Device: Foley; Drug: Misoprostol

• Registration Number: NCT01140971
• Lead Sponsor: Municipal Hospital Vila Nova Cachoeirinha

Brief Summary

PURPOSE: The purpose of this study is to determine the effectiveness of balloon dilatation (Foley) with vaginal misoprostol for cervical ripening and induction of labor.

METHOD: a randomized clinical assay has been performed with 160 women with indication of induction of labor, randomly divided in two groups, 80 for Foley catheter and 80 for misoprostol.

Detailed Description

The cesarean delivery rate has risen dramatically in almost all world. Brazil shows the highest rate in the world so we need urgently efforts to reduce this fact. Several studies have shown that maternal morbidity and mortality rates are higher in cesarean deliveries. On the other hand an abdominal delivery cost much more than a vaginal delivery.

A clinical trial to assess the performance of two simple and sheep methods can provide evidence based on local experience. Our results alow us to recommend both methods for clinical practice with a good possibility to reduce cesarean rates and without adverse events.

Study Timeline

• Study Start: 2006-01
• Primary Completion: 2008-03
• Study Completion: 2009-01
• Status Verified: 2009-09
• Study First Submitted: 2010-06-08
• Study First Submitted QC: 2010-06-09
• Last Update Submitted: 2010-06-09
• Study First Posted: 2010-06-10
• Last Update Posted: 2010-06-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 180

Inclusion Criteria

• Gestational age from 37 weeks,
• feto unic, alive and cephalic,
• Bishop index equal or lesser than four.

Exclusion Criteria

• uterine scar,
• premature rupture of the membranes,
• fetal weight bigger than 4000 g,
• previous placenta,
• conditions that imposed the immediate ending of the gestation.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Foley	Foley	Foley catheter number 14 or 16 was installed intracervical for no more than 48 hours.
Misoprostol	Misoprostol	Use 25 micrograms vaginal every 6 hours (max dosis 200 micrograms in 48 hours)

Primary Outcome Measures

Name	Time	Method
Cervical ripening	48 hous after start the method	Foley Group: catheter stay no more that 48 hours. Every 6 hours vaginal exam was performed. The cases on Bishop score increase or occurred spontaneous exit of catheter or spontaneous labour had been initiated are considered success.The failure was adopted if after48 hours occurred no cervical modifications.; Misoprostol group: was introduced 25 microgram every 6 hour (max 200microg)if cervical conditions were unchanged. In the case of cervical evolution or start of labour the method was considered success.The failure was adopted if after 48 there was no cervical modifications.

Secondary Outcome Measures

Name	Time	Method
Cesarean	The action of methods were assessed for 48 hours after start.	After 48 hours if there was no cervical ripening or espontaneous labor the case was classified as failure of method and a cesarean was performed
Need of oxytocin	48 hours after start method	In cases on the cervical ripening had occurred but the spontaneous labor not start.
need of neonatal intensive care	7 first days after birth	The condition of babies at birth and needs of intensive care as mechanic ventilation or others interventions.

Trial Locations

Locations (1)

MHVNCachoeirinha; 🇧🇷 São Paulo, Brazil