Foley Catheter Versus Vaginal Misoprostol for Cervical Ripening and Induction of Labor
NCT ID: NCT01140971
Last Updated: 2010-06-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
180 participants
INTERVENTIONAL
2006-01-31
2009-01-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Misoprostol
Use 25 micrograms vaginal every 6 hours (max dosis 200 micrograms in 48 hours)
Misoprostol
Vaginal application of 25 micrograms every 6 hours until cervical ripening reach Bishop 6 or more
Foley
Foley catheter number 14 or 16 was installed intracervical for no more than 48 hours.
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.
Interventions
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Misoprostol
Vaginal application of 25 micrograms every 6 hours until cervical ripening reach Bishop 6 or more
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* feto unic, alive and cephalic,
* Bishop index equal or lesser than four.
Exclusion Criteria
* premature rupture of the membranes,
* fetal weight bigger than 4000 g,
* previous placenta,
* conditions that imposed the immediate ending of the gestation.
19 Years
40 Years
FEMALE
No
Sponsors
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Municipal Hospital Vila Nova Cachoeirinha
OTHER
Responsible Party
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Maternidade Escola de Vila Nova Cachoeirinha
Principal Investigators
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Nelson Sass, pHD
Role: PRINCIPAL_INVESTIGATOR
Maternidade Escola de Vila Nova Cachoeirinha
Locations
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MHVNCachoeirinha
São Paulo, São Paulo, Brazil
Countries
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References
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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.
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.
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.
Other Identifiers
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MHVNCachoeirinha
Identifier Type: -
Identifier Source: org_study_id
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