Comparison of Primary and Secondary Prevention of Postpartum Hemorrhage at the Community Level in Egypt
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02226588|
Recruitment Status : Completed
First Posted : August 27, 2014
Last Update Posted : February 15, 2016
|Condition or disease||Intervention/treatment||Phase|
|Postpartum Hemorrhage||Drug: Misoprostol||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2827 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Study Start Date :||October 2014|
|Actual Primary Completion Date :||January 2016|
|Actual Study Completion Date :||January 2016|
Experimental: Secondary prevention
Single sublingual dose of 800mcg (4 tablets) misoprostol administered to women with 350-500mL postpartum blood loss as estimated using a blood absorption mat or due to deteriorating postpartum condition of the woman as determined by provider's clinical judgment
Active Comparator: Universal prophylaxis
Single oral prophylactic dose of 600mcg (3 tablets) misoprostol administered to all women within 1 minute of deliver of baby
- 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. ]Hemoglobin will be measured by primary health unit staff using a portable handheld Hemocue machine.
- Proportion of women transferred to higher level care [ Time Frame: Following delivery to postpartum visit (2 to 4 days after delivery) ]The proportion of women transferred to higher level care will be assessed. Includes the condition of woman at time of transfer and arrival at transfer facility.
- Proportion of women diagnosed with PPH [ Time Frame: After delivery of the baby up to 24 hours postpartum ]PPH will be diagnosed using the standard practices of PHU staff
- Proportion of women receiving additional interventions for PPH [ Time Frame: Following delivery to postpartum visit (2 to 4 days after delivery) ]An additional intervention could include: uterotonics, manual removal of placental fragments. bimanual compression, IV fluids given to control active bleeding.
- Proportion of women who experience side effects [ Time Frame: From time of delivery to 2 hours postpartum ]Women experiencing known side effects of misoprostol, including shivering/chills and pyrexia; severity, duration, and any additional care provided will be assessed
- Proportion of women who find the intervention acceptable [ Time Frame: Measured at postpartum visit (2 to 4 days after delivery) ]Acceptability will be assessed in an exit interview with women - women will be asked if they are willing to take misoprostol in future deliveries and about the preferences what method they would prefer (primary or secondary prevention) in future deliveries.
- Proportion of women who receive intervention per protocol [ Time Frame: within 2 hours of delivery ]To assess feasibility, we will document the proportion of women for whom the intervention arm protocol is correctly followed (including correct timing of drug administration, when necessary).
- Proportion of women experiencing a serious adverse event [ Time Frame: Within 2 to 4 days after delivery ]Serious adverse events include hysterectomy, blood transfusion, maternal death
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02226588
|Primary Health Care Units|
|Damanhour, El Beheira, Egypt|
|Primary Health Care Units|
|Kafr El Dawar, El Beheira, Egypt|
|Principal Investigator:||Nevine Hassanein, MD||Consultant|
|Principal Investigator:||Emad Darwish, MD||Alexandria University|
|Principal Investigator:||Mohamed Cherine, MD||El Galaa Teaching Hospital|
|Principal Investigator:||Rasha Dabash, MPH||Gynuity Health Projects|
|Principal Investigator:||Holly Anger, MPH||Gynuity Health Projects|