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

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ClinicalTrials.gov Identifier: NCT01140971
Recruitment Status : Completed
First Posted : June 10, 2010
Last Update Posted : June 10, 2010
Sponsor:
Information provided by:
Municipal Hospital Vila Nova Cachoeirinha

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 Not Applicable

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 Type : Interventional  (Clinical Trial)
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 : January 2006
Actual Primary Completion Date : March 2008
Actual Study Completion Date : January 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Misoprostol
U.S. FDA Resources

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 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.



Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   19 Years to 40 Years   (Adult)
Sexes 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications:
Responsible Party: Nelson Sass, Maternidade Escola de Vila Nova Cachoeirinha
ClinicalTrials.gov Identifier: NCT01140971     History of Changes
Other Study ID Numbers: MHVNCachoeirinha
First Posted: June 10, 2010    Key Record Dates
Last Update Posted: June 10, 2010
Last Verified: September 2009

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

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