Comparative Study on Effects of Sublingual Misoprostol in Addition to Standard Active Management of Third Stage of Labour in Low Risk Parturients in Lagos State University Teaching Hospital, Ikeja.
Trial Snapshot
- Phase
- Early Phase 1
- Sponsor
- Enrollment
- 660
- Primary Endpoint
- mean blood loss
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Prevention
- Masking
- Double (Participant, Care Provider)
Eligibility Criteria
- Ages
- 15 Years to 45 Years (Child, Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •singleton in longitudinal lie and cephalic presentation
Exclusion Criteria
- •refusal of consents, multiple gestation
Arms & Interventions
control
Intramuscular oxytocin 10 units, 2 tablets of placebo which will be vitamin c
Intervention: vitamin c (Drug)
study
Intramuscular oxytocin 10 units, 400 micrograms of misoprostol
Intervention: Misoprostol (Drug)
Outcomes
Primary Outcomes
mean blood loss
Time Frame: 1 hour of delivery
Secondary Outcomes
- number of participants with untowards effects(1 hour of delivery)
Investigators
Oyedeko Muyideen Oladipo
Doctor
Lagos State University