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

Municipal Hospital Vila Nova Cachoeirinha

Status: Completed

Conditions: Pregnancy, Prolonged; Oligohydramnios; Pre Eclampsia

Treatments: Drug: Misoprostol; Device: Foley

Study type: Interventional

Funder types: Other

Identifiers

NCT01140971

MHVNCachoeirinha

Details and patient eligibility

About

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.

Full 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.

Enrollment: 180 patients

Sex: Female

Ages: 19 to 40 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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180 participants in 2 patient groups

Misoprostol

Active Comparator group

Description:

Use 25 micrograms vaginal every 6 hours (max dosis 200 micrograms in 48 hours)

Treatment:

Drug: Misoprostol

Foley

Active Comparator group

Description:

Foley catheter number 14 or 16 was installed intracervical for no more than 48 hours.

Treatment:

Device: Foley