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| Name | Class |
|---|---|
| Ministry of Health and Population, Egypt | OTHER_GOV |
| University of Alexandria | OTHER |
| El Galaa Teaching Hospital | OTHER |
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The objective of this study is to compare two community-level strategies: either selective, early administration of 800 mcg sublingual misoprostol to women for secondary prevention of postpartum hemorrhage (PPH) or universal use of 600 mcg oral misoprostol at the time of delivery for prophylaxis of PPH. The significance of this cluster randomized non-inferiority trial is its potential to inform service delivery programs on clinical outcomes, program feasibility, cost, and acceptability of two different community models of PPH care using misoprostol.1. The study hypothesizes that a service delivery model that administers misoprostol for secondary prevention is non-inferior to a model that administers misoprostol for universal prophylaxis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Secondary prevention | Experimental | 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 |
|
| Universal prophylaxis | Active Comparator | Single oral prophylactic dose of 600mcg (3 tablets) misoprostol administered to all women within 1 minute of deliver of baby |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Misoprostol | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean drop in pre- to post-delivery hemoglobin level | Hemoglobin will be measured by primary health unit staff using a portable handheld Hemocue machine. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of women transferred to higher level care | 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. | Following delivery to postpartum visit (2 to 4 days after delivery) |
| Proportion of women diagnosed with PPH |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Primary Health Care Units | Damanhur | El Beheira | Egypt | |||
| Primary Health Care Units |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32448257 | Derived | Anger HA, Dabash R, Hassanein N, Darwish E, Ramadan MC, Nawar M, Charles D, Breebaart M, Winikoff B. A cluster-randomized, non-inferiority trial comparing use of misoprostol for universal prophylaxis vs. secondary prevention of postpartum hemorrhage among community level births in Egypt. BMC Pregnancy Childbirth. 2020 May 24;20(1):317. doi: 10.1186/s12884-020-03008-5. |
| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Term |
|---|---|
| D006473 | Postpartum Hemorrhage |
| ID | Term |
|---|---|
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D016595 | Misoprostol |
| ID | Term |
|---|---|
| D011459 | Prostaglandins E, Synthetic |
| D011465 | Prostaglandins, Synthetic |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
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PPH will be diagnosed using the standard practices of PHU staff |
| After delivery of the baby up to 24 hours postpartum |
| Proportion of women receiving additional interventions for PPH | An additional intervention could include: uterotonics, manual removal of placental fragments. bimanual compression, IV fluids given to control active bleeding. | Following delivery to postpartum visit (2 to 4 days after delivery) |
| Proportion of women who experience side effects | Women experiencing known side effects of misoprostol, including shivering/chills and pyrexia; severity, duration, and any additional care provided will be assessed | From time of delivery to 2 hours postpartum |
| Proportion of women who find the intervention acceptable | 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. | Measured at postpartum visit (2 to 4 days after delivery) |
| Proportion of women who receive intervention per protocol | 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). | within 2 hours of delivery |
| Proportion of women experiencing a serious adverse event | Serious adverse events include hysterectomy, blood transfusion, maternal death | Within 2 to 4 days after delivery |
| Kafr El Dawar |
| El Beheira |
| Egypt |
| D011644 | Puerperal Disorders |
| D014592 | Uterine Hemorrhage |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005231 |
| Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |