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

Primary Postpartum Haemorrhage Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02424201
• Other study ID #: LagosSU
• Status: Not yet recruiting
• Phase: Phase 0
• First received: April 18, 2015
• Last updated: April 29, 2015
• Start date: June 2015
• Est. completion date: February 2016

Study information

• Verified date: April 2015
• Source: Lagos State University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Nigeria: Federal Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 660
• Est. completion date: February 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 15 Years to 45 Years

Eligibility

Inclusion Criteria:

• singleton in longitudinal lie and cephalic presentation

Exclusion Criteria:

• refusal of consents, multiple gestation

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Postpartum Hemorrhage
• Primary Postpartum Haemorrhage

Intervention

Drug:
• Misoprostol
experimental
• vitamin c
control

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Lagos State University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	mean blood loss		1 hour of delivery	No
Secondary	number of participants with untowards effects		1 hour of delivery	No