Skip to main content
OpenTrials
Completed

NCT Number: NCT01140971

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pregnancy, Prolonged Female Urogenital Diseases and Pregnancy Complications Hypertension, Pregnancy-Induced Oligohydramnios Pre Eclampsia Pre-Eclampsia Pregnancy Complications Urogenital Diseases

Age range

19 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

MHVNCachoeirinha

São Paulo, 02720-200, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Misoprostol

Drug

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

Other names: Prostokos 25 micrograms

Foley

Device

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.

Primary outcomes

  1. Cervical ripening

    Time frame: 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 outcomes

  1. Cesarean

    Time frame: 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

  2. Need of oxytocin

    Time frame: 48 hours after start method

    In cases on the cervical ripening had occurred but the spontaneous labor not start.

  3. need of neonatal intensive care

    Time frame: 7 first days after birth

    The condition of babies at birth and needs of intensive care as mechanic ventilation or others interventions.

Sponsors and collaborators

Lead sponsor

Municipal Hospital Vila Nova Cachoeirinha

Other

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2008
Study completion
2009
First posted
Jun 10, 2010
Registry last updated
Jun 10, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.