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Sublingual Misoprostol in Reduction of Caesarean Blood Loss

NCT05532215 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 152

Last updated 2023-04-12

No results posted yet for this study

Summary

Caesarean delivery is inevitably associated with a higher amount of blood loss vis-à-vis primary postpartum haemorrhage, when compared to vaginal delivery. Oxytocin use in tropical developing countries for the reduction blood loss at caesarean section have been met with challenges of ineffectiveness due to poor transportation, inadequate storage and drug adulteration. Therefore, there is a need for an effective, temperature stable uterotonic with a lesser risk of adulteration. The study is aimed at evaluating the effectiveness and safety of adjunctive sublingual misoprostol in reducing intraoperative blood loss at caesarean section.

Conditions

  • Post Partum Hemorrhage

Interventions

DRUG

Misoprostol

The misoprostol tablets to be used in the study will be of the same brand and batch

DRUG

Oxytocin

The oxytocin ampoules to be used in the study will be of the same brand and batch

Sponsors & Collaborators

  • OZORI EBIOGBO STANLEY

    lead OTHER_GOV

Principal Investigators

  • Stanley E Ozori · Department of Obstetrics and Gynaecology, Federal Medical Centre, Yenagoa

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-14
Primary Completion
2023-10-14
Completion
2023-11-14

Countries

  • Nigeria

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05532215 on ClinicalTrials.gov