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
PHASE3
400 participants
INTERVENTIONAL
2012-02-29
2014-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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folye catheter plus vaginal IMN
intracervical foley catheter plus vaginal IMN
foley catheter
foley 14 catheter intracervical plus vaginal IMN 40 mg evry 6 hours
Vaginal IMN
IMN vaginal 40 mg every 4-6 hours
Misoprostol vaginally
intravaginal misoprostol
Misoprostol
misoprostol 50 Ug , vaginally every 4-6 hours
Interventions
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foley catheter
foley 14 catheter intracervical plus vaginal IMN 40 mg evry 6 hours
Misoprostol
misoprostol 50 Ug , vaginally every 4-6 hours
Vaginal IMN
IMN vaginal 40 mg every 4-6 hours
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Live,singleton fetus.
* Cephalic presentation.
* Intact membrane.
* Bishop score \< 6.
* Not in labour.
* Medically indicated for labour induction.
* Primigravida or parity of 3 or less.
Exclusion Criteria
* Malpresentation.
* Placenta previa.
* Sever intrauterine growth restriction.
* Multiple pregnancy.
* Polyhydramnios.
* Oligohydramnios.
* Bishop score 7 or more.
18 Years
40 Years
FEMALE
Yes
Sponsors
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Cairo University
OTHER
Responsible Party
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Waleed El-khayat
Principal investigator
Principal Investigators
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Waleed El-khayat, M.D.
Role: STUDY_DIRECTOR
Cairo University
Locations
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Cairo University
Cairo, Cairo Governorate, Egypt
Waleed El-khayat
Cairo, Cairo Governorate, Egypt
Countries
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References
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de Vaan MD, Ten Eikelder ML, Jozwiak M, Palmer KR, Davies-Tuck M, Bloemenkamp KW, Mol BWJ, Boulvain M. Mechanical methods for induction of labour. Cochrane Database Syst Rev. 2023 Mar 30;3(3):CD001233. doi: 10.1002/14651858.CD001233.pub4.
El-Khayat W, Alelaiw H, El-kateb A, Elsemary A. Comparing vaginal misoprostol versus Foley catheter plus vaginal isosorbide mononitrate for labor induction. J Matern Fetal Neonatal Med. 2016;29(3):487-92. doi: 10.3109/14767058.2015.1007036. Epub 2015 Feb 19.
Other Identifiers
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12012
Identifier Type: -
Identifier Source: org_study_id
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