Skip to content

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
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02424201
Enrollment
660
Registered
2015-04-22
Start date
2015-06-30
Completion date
2016-02-29
Last updated
2015-04-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Postpartum Haemorrhage

Keywords

uterine atony

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.

Interventions

DRUGMisoprostol

experimental

DRUGvitamin c

control

Sponsors

Lagos State University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender
FEMALE
Age
15 Years to 45 Years
Healthy volunteers
Yes

Inclusion criteria

* singleton in longitudinal lie and cephalic presentation

Exclusion criteria

* refusal of consents, multiple gestation

Design outcomes

Primary

MeasureTime frame
mean blood loss1 hour of delivery

Secondary

MeasureTime frame
number of participants with untowards effects1 hour of delivery

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 13, 2026