Misoprostol and Oxytocin in Uniject® for Postpartum Hemorrhage Prevention in Communities
Recruitment status was Not yet recruiting
This community-based cluster Randomised Control Trial will assess the feasibility, cost, risks and benefits of use of oral Misoprostol and parenteral Oxytocin in Uniject® as prophylaxis for postpartum hemorrhage (PPH) in community settings. The study will be conducted in Jamnagar district in Gujarat state in India. The hypothesis is that a program to deliver oral misoprostol and one to deliver oxytocin via Uniject® will both be effective in preventing PPH when introduced in community-based settings.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
|Official Title:||Preventing Postpartum Hemorrhage: Examining Two Strategies for PPH Prevention in Communities: Misoprostol and Oxytocin in Uniject®|
- Mean change in Pre- and post-delivery Haemoglobin [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]To establish the comparable effectiveness of two programmatic strategies, 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.
- Safety [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]Occurrence and management of side effects, timing of drug administration and serious adverse outcomes
- Clinical effectiveness [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]Change in hemoglobin ≥ 2 g/dL, prolonged third stage of labor, any additional interventions carried out.
- Programmatic feasibility [ Time Frame: 18 months ] [ Designated as safety issue: No ]Acceptability among women and providers,drug accountability, disposal and management, any problems to report, refusals or complaints by women or their families
- Cost-effectiveness [ Time Frame: 18 months ] [ Designated as safety issue: No ]Costs of supplies, wastage, refresher trainings, storage and transportation, referrals and management of side effects will be assessed.
|Study Start Date:||July 2013|
|Estimated Study Completion Date:||December 2014|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
Experimental: Group 1
600 mcg oral misoprostol
600 mcg oral misoprostol to be administered after delivery of baby and before placenta is expelled
Other Name: Misoprost
Experimental: Group 2
10 IU oxytocin in Uniject
10 IU oxytocin in Uniject will be administered after delivery of baby and before placenta is expelled
Other Name: Oxytocin in Uniject
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