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

Oligohydramnios Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Oligohydramnios
• Pre Eclampsia
• Pre-Eclampsia
• Pregnancy, Prolonged

• NCT number: NCT01140971
• Study type: Interventional
• Source: Municipal Hospital Vila Nova Cachoeirinha
• Status: Completed
• Phase: N/A
• Start date: January 2006
• Completion date: January 2009