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| Name | Class |
|---|---|
| University of Liverpool | OTHER |
| Liverpool School of Tropical Medicine | OTHER |
| Makerere University | OTHER |
| Mbale Regional Referral Hospital |
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Postpartum hemorrhage (PPH) is a major cause of maternal death in the developing world. An important strategy in the prevention of deaths is the use of uterotonic drugs for PPH prophylaxis. Misoprostol has been recognized as an option for preventing PPH as it is economical, heat stable, has a long shelf-life, and can be taken orally.
The investigators envisage that the use of self administered misoprostol after home births among mothers would be associated with a peri-partum fall in hemoglobin value of over 20% (the outcome of a fall of 2g/dl will also be tested in the pilot).
The objective of the main study will be to assess the effectiveness and safety of antenatal administration of misoprostol tablets (600mcg) for self administration immediately following home delivery for the prevention of postpartum haemorrhage. The objectives of the pilot study are to test the integrity of the study protocol, to test the randomization procedure, to assess the acceptability of the intervention, to test the logistics of follow-up, to test the data collection forms, to validate the quality of life questionnaire in this population and to determine the recruitment rate to help study planning.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| misoprostol | Active Comparator | 3 tablets of 200mcg misoprostol self-administered following home birth, taken orally immediately after delivery of baby |
|
| placebo | Placebo Comparator | 3 tablets of placebo resembling misoprostol self-administered following home birth, taken orally immediately after delivery of baby |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Misoprostol | Drug | 3 x 200mcg tablets of oral misoprostol |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in hemoglobin | Peri-partum fall in hemoglobin value of over 20% (the outcome of a fall of 2g/dl will also be tested in the pilot) following use of self-administered misoprostol after home birth | Measured during third trimester and 3-5 days postpartum |
| Measure | Description | Time Frame |
|---|---|---|
| Safety | To assess the safety of ante-natal distribution of misoprostol and its use by women at the time of their home birth, data will be collected on the number of women who report experiencing side effects (including shivering and fever), number of women who are transferred to higher level care, number of women who undergo surgical interventions, number of women who are given blood transfusions, number of maternal deaths, and number of neonatal deaths. The exact outcomes as well as the power calculations will only be finalized once the pilot study is completed. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrew Weeks | University of Liverpool | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Busiu Health Centre | Mbale | Mbale | Uganda | |||
| Lwangoli Health Centre |
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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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| OTHER |
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| placebo |
| Drug |
3 x placebo tablets resembling misoprostol taken orally |
|
| Assessed 3-5 days postpartum |
| Mbale |
| Mbale |
| Uganda |
| Mbale Regional Referral Hospital | Mbale | Mbale | Uganda |
| Siira Health Centre | Mbale | Mbale | Uganda |
| 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 |