Postpartum Hemorrhage
Conditions
Keywords
postpartum hemorrhage, prevention, misoprostol, Uniject, oxytocin
Brief summary
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.
Detailed description
This study will assess the programmatic implications (including feasibility, acceptability, costs, 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.
Interventions
DRUGmisprostol
600 mcg misoprostol oral
DEVICEUnijectTM
10 IU oxytocin delivered intramuscularly with UnijectTM
Sponsors
The Aga Khan Foundation
Guttmacher Institute
Gynuity Health Projects
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
Yes
Inclusion criteria
* women delivering at home with a trained study provider who are able to provide informed consent
Exclusion criteria
* women with known contraindications to prostaglandins
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean change in hemoglobin | during 3rd trimester and 1-3 days postpartum | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| additional interventions | during birth and 1-3 days postpartum | use of additional uterotonics, manual removal of placental fragments, etc |
| occurrence and management of side effects | 1 hour postpartum | nausea, vomiting, diarrhea, shivering, fever |
| referrals | 1-3 days postpartum | referral requested, transfers carried out, reasons for incomplete referrals/transfers |
| change in hemoglobin ≥ 2 g/dL | during third trimester and 1-3 days postpartum | — |
| acceptability | 1-3 days postpartum | acceptability according to woman of study medication, care received, side effects experienced |
| correct timing of drug administration | collected immediately following birth, verified 1-3 days postpartum | administration of the drug after the birth of the baby and verifying no twin, before the expulsion of the placenta |
Countries
Mali
Outcome results
None listed