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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: ClinicalTrials.gov
Last refreshed on: 19 October 2017
Main ID:  NCT01635439
Date of registration: 04/07/2012
Prospective Registration: No
Primary sponsor: Ain Shams University
Public title: Prostin and Propess in Induction of Labor
Scientific title: Induction of Labour: A Comparison Between Propess Vaginal Delivery System and Prostin E2 Vaginal Suppositories, A Randomized Controlled Trial.
Date of first enrolment: December 2010
Target sample size: 200
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT01635439
Study type:  Interventional
Study design:   
Phase:  Phase 3
Countries of recruitment
Saudi Arabia
Contacts
Name:     Ahmed Abdelaziz, M.D.
Address: 
Telephone:
Email:
Affiliation:  North West Armed Forces Hospital
Key inclusion & exclusion criteria

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
Health Condition(s) or Problem(s) studied
Labor Pain
Intervention(s)
Drug: Propess
Drug: Prostin E2
Primary Outcome(s)
Induction to Delivery Interval [Time Frame: 24 hours]
Secondary Outcome(s)
Need for Syntocinon Augmentation [Time Frame: 24 hours]
Normal Vaginal Delivery Rate [Time Frame: 24 hours]
Uterine Hyper-stimulation Rate [Time Frame: 24 hours]
Induction to Onset of Labor Interval [Time Frame: 24 hours]
Secondary ID(s)
NWAFH2010-1
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
North West Armed Forces Hospital
Ethics review
Results
Results available: Yes
Date Posted: 04/10/2012
Date Completed:
URL: https://clinicaltrials.gov/ct2/show/results/NCT01635439
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