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

Lagos State Ministry of Education

Status and phase: Unknown; Early Phase 1

Conditions: Primary Postpartum Haemorrhage

Treatments: Drug: Misoprostol; Drug: vitamin c

Study type: Interventional

Funder types: Other

Identifiers

NCT02424201

LagosSU

Details and patient eligibility

About

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.

Full 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.

Enrollment: 660 estimated patients

Sex: Female

Ages: 15 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• singleton in longitudinal lie and cephalic presentation

Exclusion criteria

• refusal of consents, multiple gestation

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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660 participants in 2 patient groups

study

Experimental group

Description:

Intramuscular oxytocin 10 units, 400 micrograms of misoprostol

Treatment:

Drug: Misoprostol

control

Other group

Description:

Intramuscular oxytocin 10 units, 2 tablets of placebo which will be vitamin c

Treatment:

Drug: vitamin c