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. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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19 October 2017 |
Main ID: |
NCT01635439 |
Date of registration:
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04/07/2012 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Prostin and Propess in Induction of Labor
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Scientific title:
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Induction of Labour: A Comparison Between Propess Vaginal Delivery System and Prostin E2 Vaginal Suppositories, A Randomized Controlled Trial. |
Date of first enrolment:
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December 2010 |
Target sample size:
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200 |
Recruitment status: |
Completed |
URL:
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https://clinicaltrials.gov/show/NCT01635439 |
Study type:
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Interventional |
Study design:
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Phase:
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Phase 3
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Countries of recruitment
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Saudi Arabia
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Contacts
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Name:
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Ahmed Abdelaziz, M.D. |
Address:
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Telephone:
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Email:
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Affiliation:
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North West Armed Forces Hospital |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Gestational age 37 weeks or more
- Singleton pregnancy
- Cephalic presentation.
Exclusion Criteria:
- Previous cesarean section
- Any contraindication for vaginal delivery
- Suspected Cephalo-Pelvic Disproportion
- Unexplained antepartum Hemorrhage
Age minimum:
18 Years
Age maximum:
40 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Labor Pain
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Intervention(s)
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Drug: Propess
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Drug: Prostin E2
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Primary Outcome(s)
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Induction to Delivery Interval
[Time Frame: 24 hours]
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Secondary Outcome(s)
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Need for Syntocinon Augmentation
[Time Frame: 24 hours]
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Normal Vaginal Delivery Rate
[Time Frame: 24 hours]
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Uterine Hyper-stimulation Rate
[Time Frame: 24 hours]
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Induction to Onset of Labor Interval
[Time Frame: 24 hours]
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Secondary ID(s)
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NWAFH2010-1
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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