Comparative Study on the Effects of Sublingual Misoprostol in Addition to Standard AMTSL in Low Risk Parturients in LASUTH, Ikeja.
- Registration Number
- NCT02424201
- Lead Sponsor
- Lagos State University
- Brief Summary
Postpartum haemorrhage is the leading cause of maternal haemorrhage globally. With active management of labour 3 to 16.5% of parturients still experience postpartum haemorrhage. Hence the need for an effective oxytocic in third stage of labour.
- Detailed Description
This is a prospective randomized doubleblind controlled trial involving 660 consenting pregnant women. Eligible subjects will be ransomised into 2 groups of 330 participants. All patients will receive the standard oxytocin 10 units as part of the active management of third stage of labour. However, the study group will be administered sublingual 400 misoprostol while the control group will receive 2tablets of placebo (vitamin c). Measured mean blood loss will be comparee in the 2 groups using statistical analysis.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 660
- singleton in longitudinal lie and cephalic presentation
- refusal of consents, multiple gestation
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description study Misoprostol Intramuscular oxytocin 10 units, 400 micrograms of misoprostol control vitamin c Intramuscular oxytocin 10 units, 2 tablets of placebo which will be vitamin c
- Primary Outcome Measures
Name Time Method mean blood loss 1 hour of delivery
- Secondary Outcome Measures
Name Time Method number of participants with untowards effects 1 hour of delivery