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A comparison of the efficacy and safety of 600 mcg and 400 mcg of intrauterine misoprostol with oxytocin for the prevention of primary postpartum haemorrhage at Caesarean section: A triple-blind randomised controlled trial

A comparison of the efficacy and safety of 600 mcg and 400 mcg of intrauterine misoprostol with oxytocin for the prevention of primary postpartum haemorrhage at Caesarean section: A triple-blind randomised controlled trial

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
PACTR
Registry ID
PACTR202505587081266
Enrollment
196
Registered
2025-05-15
Start date
2024-12-02
Completion date
Unknown
Last updated
2026-09-14

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

Conditions

postpartum haemorrhage prevention

Interventions

Efficacy and safety of intrauterine 400 mcg of misoprostol to prevent primary postpartum haemorrhage
Insertion of 600 mcg of misoprostol

Sponsors

Self
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: Inclusion Criteria • Singleton gestation billed for CS • Gestational ages of 37- 42 weeks

Exclusion criteria

Exclusion criteria: Exclusion Criteria • History of prostaglandin allergy • Antepartum haemorrhage (abruption placenta,placenta praevia, vasa praevia) • Multiple pregnancy • Obstructed labour • Sickle Cell Disease • Pre-eclampsia with HELLP syndrome • Pregnancy with coagulopathy • Intrauterine foetal death with coagulopathy.

Design outcomes

Primary

MeasureTime frame
Primary Outcome Measures is the estimation of blood loss during and after caesarean section following administration of oxytocin and various doses of intrauterine misoprostol. Secondary outcome measures includes: •Postpartum drop in haematocrits (48 hours post delivery) •Need for blood transfusion (before discharge) •Need for additional oxytocic or surgical intervention for PPH (within 24 hours of delivery) •Misoprostol-related adverse effects such as shivering, vomiting, nausea, diarrhoea, pyrexia (Body Temperature >38*C), hyperpyrexia (Body Temperature >40*C) will be evaluated.

Secondary

MeasureTime frame
Side effects of misoprostol; need for additional uterotonic and packed cell volume

Countries

Nigeria

Contacts

Public ContactChinyere Nwankwo

Registrar

Chidbest1@gmail.com+2348134377035

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Sep 19, 2026