Postpartum Hemorrhage
Conditions
Keywords
Primary postpartum hemorrhage, PPH, uterine atony, high fever, hyperpyrexia
Brief summary
This study will evaluate side effects after sublingual misoprostol (600 mcg) as a first-line treatment for primary postpartum hemorrhage (PPH) due to suspected uterine atony.
Detailed description
The study purpose is to confirm whether a lower, 600 mcg dose of sublingual misoprostol will reduce the incidence of elevated body temperature (≥40°C) associated with misoprostol. The study will compare the incidence of high fevers following treatment with 600 mcg sublingual misoprostol to previously documented rates using 800 mcg sublingual misoprostol. An additional line of research is to investigate whether some women are more susceptible to experiencing high fevers following misoprostol administration, and whether genetic factors are responsible for misoprostol-induced fevers.
Interventions
DRUGMisoprostol
600 mcg of sublingual misoprostol
Sponsors
Bill and Melinda Gates Foundation
University of Liverpool
Gynuity Health Projects
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
14 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Able and willing to give informed consent * Vaginal delivery * Postpartum hemorrhage due to suspected uterine atony * Oxytocin given during 3rd stage of labor
Exclusion criteria
* Known allergy to prostaglandins or misoprostol * Underwent cesarean section * Postpartum hemorrhage NOT due to suspected uterine atony * Oxytocin NOT given during 3rd stage of labor * Severe ill health * Unable to give informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of fever above 40.0 degrees centigrade | Body temperature measured at 60 minutes and 90 minutes post-treatment with misoprostol for PPH | % of women with body temperature measures ≥40°C |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Side effect profile of misoprostol for PPH treatment | Side effects observed for 3 hours post-treatment with misoprostol for PPH | % of women experiencing any shivering and any fever or any other side effect |
| Acceptability of side effect profile among women | Women interviewed prior to hospital discharge about acceptability of side effects (24 hours postpartum) | % of women who rate side effects as acceptable, neutral, unacceptable, don't know |
Countries
Ecuador
Outcome results
None listed