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| Name | Class |
|---|---|
| ChildFund International | UNKNOWN |
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This is a large, community-based, cluster-randomized trial to compare routine prophylactic use of 600 mcg oral misoprostol and 10 IU oxytocin delivered by UnijectTM intramuscularly during the third stage of labor
This study will assess the programmatic implications (including feasibility, acceptability, risks and benefits) at the community level of the introduction of misoprostol and/or oxytocin in UnijectTM for the prevention of PPH and will help to identify the appropriate niche for both drugs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Misoprostol | Experimental | 600 mcg oral misoprostol administered during the third stage of labor |
|
| UnijectTM | Experimental | 10 IU oxytocin delivered IM with UnijectTM during he third stage of labor |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Misoprostol | Drug | 600 mcg misoprostol oral |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean change in hemoglobin | To establish the comparable effectiveness of two technologies, individual pre- and post-delivery Hb measures will be taken to calculate change in Hb. This will be done using a Hemocue Hemoglobin machine + cuvette (HemoCue, Angelholm, Sweden). The Hemocue is a simple means of collecting Hb measures at the community-level where traditional laboratory techniques are not feasible | during 3rd trimester and 1-3 days postpartum |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence and management of side effects | nausea, vomiting, diarrhea, shivering, fever | 1 hour postpartum |
| correct timing of drug administration | administration of the drug after the birth of the baby and verifying no twin, before the expulsion of the placenta |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Health huts in the district of Thiadiaye and Kolda | Thiadiay and Kolda | Thiadiaye and Kolda | Senegal |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26718808 | Derived | Diop A, Daff B, Sow M, Blum J, Diagne M, Sloan NL, Winikoff B. Oxytocin via Uniject (a prefilled single-use injection) versus oral misoprostol for prevention of postpartum haemorrhage at the community level: a cluster-randomised controlled trial. Lancet Glob Health. 2016 Jan;4(1):e37-44. doi: 10.1016/S2214-109X(15)00219-3. |
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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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| UnijectTM | Device | 10 IU oxytocin delivered intramuscularly with UnijectTM |
|
| collected immediately following birth, verified 1-3 days postpartum |
| change in hemoglobin ≥ 2 g/dL | during third trimester and 1-3 days postpartum |
| additional interventions | use of additional uterotonics, manual removal of placental fragments, etc | during birth |
| referrals | referral requested, transfers carried out, reasons for incomplete referrals/transfers | 0-3 days postpartum |
| acceptability | acceptability according to woman of study medication, care received, side effects experienced | 1-3 days postpartum |
| 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 |