TRANSCERVICAL FOLEY CATHETER (FOLEY) Versus INTRAVAGINAL MISOPROSTOL FOR CERVICAL RIPENING AND INDUCTION OF LABOR: A RANDOMIZED CLINICAL TRIAL.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 180
- Locations
- 1
- Primary Endpoint
- Cervical ripening
Study Overview
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.
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
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 19 Years to 40 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Misoprostol
Use 25 micrograms vaginal every 6 hours (max dosis 200 micrograms in 48 hours)
Intervention: Misoprostol (Drug)
Foley
Foley catheter number 14 or 16 was installed intracervical for no more than 48 hours.
Intervention: Foley (Device)
Outcomes
Primary Outcomes
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
- Cesarean(The action of methods were assessed for 48 hours after start.)
- Need of oxytocin(48 hours after start method)
- need of neonatal intensive care(7 first days after birth)