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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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23 February 2016 |
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Main ID: |
NCT02226588 |
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Date of registration:
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25/08/2014 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Comparison of Primary and Secondary Prevention of Postpartum Hemorrhage at the Community Level in Egypt
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Scientific title:
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Two Community Strategies Comparing Use of Misoprostol for Secondary Prevention to Primary Prevention for Postpartum Hemorrhage: A Randomized Cluster Non-Inferiority Study in El Beheira Governorate, Egypt |
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Date of first enrolment:
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October 2014 |
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Target sample size:
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2827 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02226588 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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Phase:
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Phase 4
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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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Rasha Dabash, MPH |
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Address:
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Telephone:
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Email:
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Affiliation:
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Gynuity Health Projects |
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Name:
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Mohamed Cherine, 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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El Galaa Teaching Hospital |
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Name:
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Holly Anger, MPH |
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Address:
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Telephone:
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Email:
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Affiliation:
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Gynuity Health Projects |
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Name:
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Nevine Hassanein, 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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Consultant |
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Name:
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Emad Darwish, 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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Alexandria University |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Willing and able to give informed consent
- Vaginal delivery
- Agrees to participate in follow-up interview
- Agrees to have pre- and post-hemoglobin taken
- Delivery at woman's home or at the primary health unit (PHU)
Exclusion Criteria:
- Too advanced into active labor to provide consent
- Known allergy to misoprostol and/or other prostaglandin
- Pregnancy complications, such as hypertension, suspected multiple pregnancy, previous
caesarean section, suspected still birth, ante-partum hemorrhage, and previous
complication in the third trimester
Age minimum:
N/A
Age maximum:
N/A
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Postpartum Hemorrhage
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Intervention(s)
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Drug: Misoprostol
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Primary Outcome(s)
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Mean drop in pre- to post-delivery hemoglobin level
[Time Frame: Pre-delivery hemoglobin will be measured during a third trimester antenatal care visit or during early labor. Post-delivery hemoglbin will be measured 2 to 4 days after delivery of the baby.]
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Secondary Outcome(s)
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Proportion of women who experience side effects
[Time Frame: From time of delivery to 2 hours postpartum]
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Proportion of women diagnosed with PPH
[Time Frame: After delivery of the baby up to 24 hours postpartum]
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Proportion of women receiving additional interventions for PPH
[Time Frame: Following delivery to postpartum visit (2 to 4 days after delivery)]
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Proportion of women transferred to higher level care
[Time Frame: Following delivery to postpartum visit (2 to 4 days after delivery)]
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Proportion of women experiencing a serious adverse event
[Time Frame: Within 2 to 4 days after delivery]
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Proportion of women who find the intervention acceptable
[Time Frame: Measured at postpartum visit (2 to 4 days after delivery)]
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Proportion of women who receive intervention per protocol
[Time Frame: within 2 hours of delivery]
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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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