NCT05532215

Sublingual Misoprostol in Reduction of Caesarean Blood Loss

Comparison Between Adjunctive Sublingual Misoprostol Versus Adjunctive Placebo in the Reduction of Intraoperative Blood Loss During Caesarean Section

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 152 (estimated)
• Sponsor: OZORI EBIOGBO STANLEY · Other Government
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

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.

Detailed description

It would be a double blind randomized controlled trial. One hundred and fifty-two pregnant women at term who have indications for caesarean section and have risk factors for primary postpartum haemorrhage, as well as meet the eligibility criteria would be randomized equally into two study arms (Misoprostol study arm and Placebo study arm) after informed consent. The Misoprostol study arm will receive 400 mcg of sublingual misoprostol as two 200 mcg misoprostol tablets. The Placebo study arm would receive two sublingual placebo tablets similar to the misoprostol tablets. The Misoprostol and the Placebo tablets will be given in each study arm at the point of starting the uterine incision at caesarean section. Both study arms would receive routine intravenous oxytocin at the time of clamping of the umbilical cord. The outcome measures will be estimated intraoperative blood loss, the need for additional intraoperative oxytocic, blood transfusion, the occurrence of side effects, and incidence of primary postpartum haemorrhage.

Conditions

• Post Partum Hemorrhage

Interventions

Type	Name	Description
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

Timeline

• Start date: 2023-03-14
• Primary completion: 2023-10-14
• Completion: 2023-11-14
• First posted: 2022-09-08
• Last updated: 2023-04-12

Locations

1 site across 1 country: Nigeria