Clinical trial NCT01140971: Foley Catheter Versus Vaginal Misoprostol for Cervical Ripening and Induction of Labor
Official title: TRANSCERVICAL FOLEY CATHETER (FOLEY) Versus INTRAVAGINAL MISOPROSTOL FOR CERVICAL RIPENING AND INDUCTION OF LABOR: A RANDOMIZED CLINICAL TRIAL.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy, Prolonged
Pre Eclampsia
Oligohydramnios
Keywords: Balloon dilatation,
misoprostol,
cervical ripening,
obstetric labor,
labor induced.
Lead sponsor: Municipal Hospital Vila Nova Cachoeirinha
Sponsor class: OTHER
First posted: 2010-06-10
Enrollment: 180
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Cervical ripening
timeFrame: 48 hous after start the method
Secondary outcomes:
measure: Cesarean
timeFrame: The action of methods were assessed for 48 hours after start.
measure: Need of oxytocin
timeFrame: 48 hours after start method
measure: need of neonatal intensive care
timeFrame: 7 first days after birth
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: MHVNCachoeirinha
Study officials:
affiliation: Maternidade Escola de Vila Nova Cachoeirinha
name: Nelson Sass, pHD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sciscione AC, Muench M, Pollock M, Jenkins TM, Tildon-Burton J, Colmorgen GH. Transcervical Foley catheter for preinduction cervical ripening in an outpatient versus inpatient setting. Obstet Gynecol. 2001 Nov;98(5 Pt 1):751-6. doi: 10.1016/s0029-7844(01)01579-4.
citation: Afolabi BB, Oyeneyin OL, Ogedengbe OK. Intravaginal misoprostol versus Foley catheter for cervical ripening and induction of labor. Int J Gynaecol Obstet. 2005 Jun;89(3):263-7. doi: 10.1016/j.ijgo.2005.02.010. Epub 2005 Apr 2.
citation: Boulvain M, Kelly A, Lohse C, Stan C, Irion O. Mechanical methods for induction of labour. Cochrane Database Syst Rev. 2001;(4):CD001233. doi: 10.1002/14651858.CD001233.