Postpartum Hemorrhage (PPH) Clinical Trial
Official title:
Misoprostol for the Treatment of Postpartum Haemorrhage (PPH) Following Self- Administration of Misoprostol Prophylaxis in Home Deliveries.
| Verified date | July 2016 |
| Source | Gynuity Health Projects |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Afghanistan: Ministry of Public Health |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 70 |
| Est. completion date | February 2016 |
| Est. primary completion date | February 2016 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Female |
| Age group | N/A and older |
| Eligibility |
Inclusion Criteria: - Women must be pregnant - Must be able to provide informed consent - Must agree to have a community health worker present at the time of delivery - Must agree to participate in a follow up interview by the study midwife - Must agree to have pre and postpartum haemoglobin taken Exclusion Criteria: - Women who do not meet the inclusion criteria |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Afghanistan | Home delivery setting | Darwaz, Ishkashim, Shugnan, Wakhan districts | Badakshan Province |
| Lead Sponsor | Collaborator |
|---|---|
| Gynuity Health Projects | Aga Khan Health Services |
Afghanistan,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | No |
| Secondary | 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 | Yes |
| Secondary | additional interventions | Additional interventions and additional care provided to the woman, # of referrals and transfers | immediately after delivery; 3-5 days post delivery | Yes |
| Secondary | Acceptability | Acceptability and management of side effects, acceptablity of taking the drugs | immediately after delivery; 3-5 days post delivery | No |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT05542043 -
Risk Factors for Postpartum Hemorrhage in Patients With Histologically Verified Placenta Accreta
|