NCT01140971

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

TRANSCERVICAL FOLEY CATHETER (FOLEY) Versus INTRAVAGINAL MISOPROSTOL FOR CERVICAL RIPENING AND INDUCTION OF LABOR: A RANDOMIZED CLINICAL TRIAL.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 180 (actual)
• Sponsor: Municipal Hospital Vila Nova Cachoeirinha · Academic / Other
• Sex: Female
• Age: 19 Years – 40 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pregnancy, Prolonged
• Pre Eclampsia
• Oligohydramnios

Interventions

Type	Name	Description
DRUG	Misoprostol	Vaginal application of 25 micrograms every 6 hours until cervical ripening reach Bishop 6 or more
DEVICE	Foley	After Foley introduction, 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.

Timeline

• Start date: 2006-01-01
• Primary completion: 2008-03-01
• Completion: 2009-01-01
• First posted: 2010-06-10
• Last updated: 2010-06-10

Locations

1 site across 1 country: Brazil