Trial | NCT01140971  Report issue

Title

Foley Catheter Versus Vaginal Misoprostol for Cervical Ripening and Induction of Labor
TRANSCERVICAL FOLEY CATHETER (FOLEY) Versus INTRAVAGINAL MISOPROSTOL FOR CERVICAL RIPENING AND INDUCTION OF LABOR: A RANDOMIZED CLINICAL TRIAL.

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    misoprostol ...

  • Study Participants

    180
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.
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 Started
Jan 31
2006
Primary Completion
Mar 31
2008
Study Completion
Jan 31
2009
Last Update
Jun 10
2010
Estimate

Drug Misoprostol

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

  • Other names: Prostokos 25 micrograms

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.

Foley Active Comparator

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

Misoprostol Active Comparator

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

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.
No Results Posted