Intrauterine Misoprostol Versus Intravenous Oxytocin Infusion During Cesarean Delivery

Phase 3

Completed

• Conditions: Post Partum Hemorrhage
• Interventions: Drug: Misoprostol; Drug: Oxytocin

• Registration Number: NCT03148574
• Lead Sponsor: Assiut University

Brief Summary

Bleeding is still the major cause of mortality and morbidity in postpartum period. World health organization has reported 585000 deaths for pregnancy each year. Twenty five percent of cases die from post-partum bleeding. Mean amount of blood lost is 500 ml during normal vaginal delivery, 1000 ml in cesarean section, and 3500 ml during cesarean section with emergency hysterectomy

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-05-09
• Study First Submitted QC: 2017-05-09
• Study First Posted: 2017-05-11
• Study Start: 2017-07-02
• Primary Completion: 2019-09-15
• Study Completion: 2019-12-15
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-22
• Last Update Posted: 2021-04-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 240

Inclusion Criteria

1-Uncomplicated pregnancy, 2-Had no hypersensitivity or contraindications to prostaglandins.

3-Had no history of coagulopathy. 4-Accepting to participate in the study.

Exclusion Criteria

\1-women with anemia (Haemoglobin <8 gram ). 2 placental abnormality (e.g placenta previa,placenta abruption ) 3. History of complications at previous pregnancy especially postpartum hemorrhage. 4- Maternal hypertension , current or previous history of heart disease ,liver ,Renal disorders or known coagulopathy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
misoprostol	Misoprostol	intrauterine 400 microgram
oxytocin	Oxytocin	intravenous infusion 10 units

Primary Outcome Measures

Name	Time	Method
amount of intraoperative blood loss	30 minutes

Trial Locations

Locations (1)

Assiut Faculty of Medicine; 🇪🇬 Assiut, Egypt