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

This study has been completed.
Sponsor:
Information provided by:
Municipal Hospital Vila Nova Cachoeirinha
ClinicalTrials.gov Identifier:
NCT01140971
First received: June 8, 2010
Last updated: June 9, 2010
Last verified: September 2009
  Purpose

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 Intervention
Pregnancy, Prolonged
Pre Eclampsia
Oligohydramnios
Drug: Misoprostol
Device: Foley

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by Municipal Hospital Vila Nova Cachoeirinha:

Primary Outcome Measures:
  • Cervical ripening [ Time Frame: 48 hous after start the method ] [ Designated as safety issue: Yes ]

    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 [ Time Frame: The action of methods were assessed for 48 hours after start. ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 48 hours after start method ] [ Designated as safety issue: Yes ]
    In cases on the cervical ripening had occurred but the spontaneous labor not start.

  • need of neonatal intensive care [ Time Frame: 7 first days after birth ] [ Designated as safety issue: Yes ]
    The condition of babies at birth and needs of intensive care as mechanic ventilation or others interventions.


Enrollment: 180
Study Start Date: January 2006
Study Completion Date: January 2009
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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.

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.

  Eligibility

Ages Eligible for Study:   19 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01140971

Locations
Brazil
MHVNCachoeirinha
São Paulo, Brazil, 02720-200
Sponsors and Collaborators
Municipal Hospital Vila Nova Cachoeirinha
Investigators
Principal Investigator: Nelson Sass, pHD Maternidade Escola de Vila Nova Cachoeirinha
  More Information

Publications:
Responsible Party: Nelson Sass, Maternidade Escola de Vila Nova Cachoeirinha
ClinicalTrials.gov Identifier: NCT01140971     History of Changes
Other Study ID Numbers: MHVNCachoeirinha
Study First Received: June 8, 2010
Last Updated: June 9, 2010
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Municipal Hospital Vila Nova Cachoeirinha:
Balloon dilatation,
misoprostol,
cervical ripening,
obstetric labor,
labor induced.

Additional relevant MeSH terms:
Eclampsia
Pre-Eclampsia
Pregnancy, Prolonged
Oligohydramnios
Hypertension, Pregnancy-Induced
Pregnancy Complications
Misoprostol
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs
Abortifacient Agents, Nonsteroidal
Abortifacient Agents

ClinicalTrials.gov processed this record on July 28, 2014