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

Primary Purpose

Pregnancy, Prolonged, Pre Eclampsia, Oligohydramnios

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Misoprostol
Foley
Sponsored by
Municipal Hospital Vila Nova Cachoeirinha
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pregnancy, Prolonged focused on measuring Balloon dilatation,, misoprostol,, cervical ripening,, obstetric labor,, labor induced.

Eligibility Criteria

19 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • MHVNCachoeirinha

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Misoprostol

Foley

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
Need of oxytocin
In cases on the cervical ripening had occurred but the spontaneous labor not start.
need of neonatal intensive care
The condition of babies at birth and needs of intensive care as mechanic ventilation or others interventions.

Full Information

First Posted
June 8, 2010
Last Updated
June 9, 2010
Sponsor
Municipal Hospital Vila Nova Cachoeirinha
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1. Study Identification

Unique Protocol Identification Number
NCT01140971
Brief Title
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

2. Study Status

Record Verification Date
September 2009
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
March 2008 (Actual)
Study Completion Date
January 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Municipal Hospital Vila Nova Cachoeirinha

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pregnancy, Prolonged, Pre Eclampsia, Oligohydramnios
Keywords
Balloon dilatation,, misoprostol,, cervical ripening,, obstetric labor,, labor induced.

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
180 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Misoprostol
Arm Type
Active Comparator
Arm Description
Use 25 micrograms vaginal every 6 hours (max dosis 200 micrograms in 48 hours)
Arm Title
Foley
Arm Type
Active Comparator
Arm Description
Foley catheter number 14 or 16 was installed intracervical for no more than 48 hours.
Intervention Type
Drug
Intervention Name(s)
Misoprostol
Other Intervention Name(s)
Prostokos 25 micrograms
Intervention Description
Vaginal application of 25 micrograms every 6 hours until cervical ripening reach Bishop 6 or more
Intervention Type
Device
Intervention Name(s)
Foley
Intervention Description
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 Measure Information:
Title
Cervical ripening
Description
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.
Time Frame
48 hous after start the method
Secondary Outcome Measure Information:
Title
Cesarean
Description
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
Time Frame
The action of methods were assessed for 48 hours after start.
Title
Need of oxytocin
Description
In cases on the cervical ripening had occurred but the spontaneous labor not start.
Time Frame
48 hours after start method
Title
need of neonatal intensive care
Description
The condition of babies at birth and needs of intensive care as mechanic ventilation or others interventions.
Time Frame
7 first days after birth

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nelson Sass, pHD
Organizational Affiliation
Maternidade Escola de Vila Nova Cachoeirinha
Official's Role
Principal Investigator
Facility Information:
Facility Name
MHVNCachoeirinha
City
São Paulo
ZIP/Postal Code
02720-200
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
11704164
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.
Results Reference
background
PubMed Identifier
15919393
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.
Results Reference
background
PubMed Identifier
11687101
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.
Results Reference
background

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

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