NCT02424201

Comparative Study on the Effects of Sublingual Misoprostol in Addition to Standard AMTSL in Low Risk Parturients in LASUTH, Ikeja.

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.

• Status: Unknown
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 660 (estimated)
• Sponsor: Lagos State University · Academic / Other
• Sex: Female
• Age: 15 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Primary Postpartum Haemorrhage

Interventions

Type	Name	Description
DRUG	Misoprostol	experimental
DRUG	vitamin c	control

Timeline

• Start date: 2015-06-01
• Primary completion: 2015-12-01
• Completion: 2016-02-01
• First posted: 2015-04-22
• Last updated: 2015-04-30