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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT02952807 |
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Date of registration:
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31/10/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Vaginal Misoprostol and Foley Catheter for Induction of Labor
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Scientific title:
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Sequential Versus Concurrent Use of Vaginal Misoprostol Plus Foley Catheter for Induction of Labor |
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Date of first enrolment:
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January 2016 |
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Target sample size:
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160 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02952807 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 2
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Countries of recruitment
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Egypt
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Contacts
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Name:
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ibrahim A el sharkwy, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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FACULTY OF MEDICINE ,ZAGAZIG UNIVERSITY |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Indication for labour induction Term pregnancy with alive fetus Bishop score less than
five
Exclusion Criteria:
- Age less than 18 years Previous uterine scar Nonvertex presentation Non-reassuring
fetal status Fetal anomalies Fetal growth restriction Genital bleeding Tumors,
malformations and/or ulcers of vulva, perineum or vagina
Age minimum:
18 Years
Age maximum:
45 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Induction of Labor Affected Fetus / Newborn
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Intervention(s)
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Drug: Misoprostol
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Device: Foley Catheter
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Primary Outcome(s)
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induction delivery interval (time from starting induction to delivery)
[Time Frame: 48hours]
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Secondary Outcome(s)
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Cesarean section
[Time Frame: 72h]
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Hyperstimulation syndrome
[Time Frame: 24h]
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Serious maternal morbidity or maternal death
[Time Frame: 42 days]
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Severe neonatal morbidity or perinatal death
[Time Frame: 28 days]
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Failed induction (failure to elicit contraction after 72 hours)
[Time Frame: 72h]
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Need of oxytocin for augmentation of labour
[Time Frame: 48h]
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Number of doses needed to bring on labour
[Time Frame: 48h]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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