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| Name | Class |
|---|---|
| Aga Khan University | OTHER |
| Aga Khan Health Services | OTHER |
| The Aga Khan Foundation | OTHER |
| Family Care International |
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Postpartum haemorrhage (PPH) remains a leading cause of maternal mortality, despite treatment with conventional methods. Uncontrolled reports and three small randomised controlled trials have suggested that misoprostol may have an additive effect to routine treatment, and there is a serious danger that this method will be used widely without research to document the effectiveness or risks of this method. In this randomised controlled trial (RCT), we propose to test whether 600 μg of sublingually administered misoprostol in women requiring additional uterotonics after delivery, and after routine syntocinon to all women during or after delivery, has additional effects above the additional conventional uterotonics in reducing PPH. Women with measured blood loss greater than or equal to 500 mls in 4 Karachi hospitals who give consent will be given locally routine treatment for PPH. In addition, they will be enrolled by drawing the next of a series of randomised treatment packs containing misoprostol or placebo. The primary outcome measure will be blood loss greater than or equal to 500 mls after enrolment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Misoprostol | Experimental | three tablets of active misoprostol (600 mcg) given sublingually |
|
| Placebo | Placebo Comparator | three tablets resembling misoprostol given sublingually |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Misoprostol | Drug | 600 mcg of sublingual misoprostol |
|
| Measure | Description | Time Frame |
|---|---|---|
| Blood loss greater than or equal to 500 mls after enrolment | Blood loss measured for minimum of 1 hour or until active bleeding ceased |
| Measure | Description | Time Frame |
|---|---|---|
| Average blood loss | Blood loss measured for minimum of one hour or until active bleeding ceased | |
| Clinical complications (need for transfusion, hysterectomy) | After delivery and prior to hospital discharge |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nadeem F Zuberi, MD | Aga Khan University Hospital, Karachi | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aga Khan University Hospital | Karachi | Pakistan | ||||
| The Aga Khan Health Services |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33232518 | Derived | Parry Smith WR, Papadopoulou A, Thomas E, Tobias A, Price MJ, Meher S, Alfirevic Z, Weeks AD, Hofmeyr GJ, Gulmezoglu AM, Widmer M, Oladapo OT, Vogel JP, Althabe F, Coomarasamy A, Gallos ID. Uterotonic agents for first-line treatment of postpartum haemorrhage: a network meta-analysis. Cochrane Database Syst Rev. 2020 Nov 24;11(11):CD012754. doi: 10.1002/14651858.CD012754.pub2. | |
| 18718007 |
| 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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| OTHER |
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| Pre-delivery and post-delivery hemoglobin measures | Pre-delivery hemoglobin measured upon admission to hospital (during labor) and measured postpartum 12-24 hours after delivery |
| Side effects | observed or reported following study treatment and prior to discharge |
| Karachi |
| Pakistan |
| Derived |
| Zuberi NF, Durocher J, Sikander R, Baber N, Blum J, Walraven G. Misoprostol in addition to routine treatment of postpartum hemorrhage: a hospital-based randomized-controlled trial in Karachi, Pakistan. BMC Pregnancy Childbirth. 2008 Aug 21;8:40. doi: 10.1186/1471-2393-8-40. |
| 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 |