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| Name | Class |
|---|---|
| Aga Khan Health Services | OTHER |
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Misoprostol, a prostaglandin E1 that induces uterine contractions, has been proposed as a low cost, easy-to-use option for prevention and treatment of Postpartum Haemorrhage (PPH), especially in settings where injectable uterotonics are not yet available or feasible to use.
A double-blinded individual randomized controlled study of misoprostol versus placebo in home deliveries in four districts in the Badakshan Province in Afghanistan. The study will recruit pregnant women who are likely to deliver at home. All women enrolled in the study will receive 600 mcg misoprostol to be self-administered as prophylaxis for PPH after delivery of their baby (ies) and before delivery of the placenta.
Women who experience a PPH will be randomized to receive either: a) standard of care + 800 mcg misoprostol (four 200 mcg tablets) or b) standard of care + four placebo tablets resembling misoprostol. In this setting, standard of care is referral.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| misoprostol | Active Comparator | 800mcg misoprostol (four tablets of 200 mcg administered sublingually) |
|
| placebo | Placebo Comparator | 4 placebo tablets (resembling misoprostol) administered sublingually |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| placebo | Other | 4 placebo tablets (resembling misoprostol) administered sublingually |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Hb of greater than or equal to 2 g/dl from pre- to post-delivery | The primary outcome will measure the proportion of women who experience a drop in their haemoglobin concentration (Hb) of greater than 2 g/dl from pre- to post-delivery. The outcome will be compared between the two treatment groups. | 3-5 days after delivery |
| Measure | Description | Time Frame |
|---|---|---|
| Side effects | Observed side effects: perceived severity, additional care provided Any serious adverse outcomes including uterine rupture, hysterectomy, hospitalization, maternal deaths, and neonatal deaths. | immediately after delivery; 3-5 days post delivery |
| additional interventions |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shafiq Mirzazada | Aga Khan Health Services | Principal Investigator |
| Gijs Walraven | Secretariat of His Highness the Aga Khan, Aiglemont | Study Director |
| Dina Abbas | Gynuity Health Projects | Study Director |
| Jill Durocher | Gynuity Health Projects | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Home delivery setting | Darwaz, Ishkashim, Shugnan, Wakhan Districts | Badakshan Province | Afghanistan |
| 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. | |
| 32503556 |
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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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| Misoprostol |
| Drug |
800mcg misoprostol (4 200mcg tablets administered sublingually) |
|
Additional interventions and additional care provided to the woman, # of referrals and transfers |
| immediately after delivery; 3-5 days post delivery |
| Acceptability | Acceptability and management of side effects, acceptablity of taking the drugs | immediately after delivery; 3-5 days post delivery |
| Derived |
| Abbas DF, Mirzazada S, Durocher J, Pamiri S, Byrne ME, Winikoff B. Testing a home-based model of care using misoprostol for prevention and treatment of postpartum hemorrhage: results from a randomized placebo-controlled trial conducted in Badakhshan province, Afghanistan. Reprod Health. 2020 Jun 5;17(1):88. doi: 10.1186/s12978-020-00933-8. |
| 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 |