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

Sponsor

Municipal Hospital Vila Nova Cachoeirinha (Other)

Overall Status

Completed

CT.gov ID

NCT01140971

Collaborator

(none)

180

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pregnancy, Prolonged Pre Eclampsia Oligohydramnios	Drug: Misoprostol Device: Foley	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

180 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jan 1, 2006

Actual Primary Completion Date :

Mar 1, 2008

Actual Study Completion Date :

Jan 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Misoprostol Use 25 micrograms vaginal every 6 hours (max dosis 200 micrograms in 48 hours)	Drug: Misoprostol Vaginal application of 25 micrograms every 6 hours until cervical ripening reach Bishop 6 or more Other Names: Prostokos 25 micrograms
Active Comparator: Foley Foley catheter number 14 or 16 was installed intracervical for no more than 48 hours.	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.

Arm

Intervention/Treatment

Active Comparator: Misoprostol

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

Drug: Misoprostol

Vaginal application of 25 micrograms every 6 hours until cervical ripening reach Bishop 6 or more

Other Names:

Prostokos 25 micrograms

Active Comparator: Foley

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

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.

Outcome Measures

Primary Outcome Measures

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

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.