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

Oligohydramnios Clinical Trial

Official title:

TRANSCERVICAL FOLEY CATHETER (FOLEY) Versus INTRAVAGINAL MISOPROSTOL FOR CERVICAL RIPENING AND INDUCTION OF LABOR: A RANDOMIZED CLINICAL TRIAL.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01140971
• Other study ID #: MHVNCachoeirinha
• Status: Completed
• Phase: N/A
• First received: June 8, 2010
• Last updated: June 9, 2010
• Start date: January 2006
• Est. completion date: January 2009

Study information

• Verified date: September 2009
• Source: Municipal Hospital Vila Nova Cachoeirinha
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: January 2009
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 19 Years to 40 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Oligohydramnios
• Pre Eclampsia
• Pre-Eclampsia
• Pregnancy, Prolonged

Intervention

Drug:
• Misoprostol
Vaginal application of 25 micrograms every 6 hours until cervical ripening reach Bishop 6 or more

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.

Locations

Country	Name	City	State
Brazil	MHVNCachoeirinha	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Municipal Hospital Vila Nova Cachoeirinha

Country where clinical trial is conducted

Brazil, 

References & Publications (3)

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. Epub 2005 Apr 2. — View Citation

Boulvain M, Kelly A, Lohse C, Stan C, Irion O. Mechanical methods for induction of labour. Cochrane Database Syst Rev. 2001;(4):CD001233. Review. Update in: Cochrane Database Syst Rev. 2012;3:CD001233. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cervical ripening	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.	48 hous after start the method	Yes
Secondary	Cesarean	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	The action of methods were assessed for 48 hours after start.	Yes
Secondary	Need of oxytocin	In cases on the cervical ripening had occurred but the spontaneous labor not start.	48 hours after start method	Yes
Secondary	need of neonatal intensive care	The condition of babies at birth and needs of intensive care as mechanic ventilation or others interventions.	7 first days after birth	Yes