Intrauterine Misoprostol Versus Intravenous Oxytocin Infusion During Cesarean Delivery

Assiut University

Status and phase: Completed; Phase 3

Conditions: Post Partum Hemorrhage

Treatments: Drug: Oxytocin; Drug: Misoprostol

Study type: Interventional

Funder types: Other

Identifiers

NCT03148574

IUM

Details and patient eligibility

About

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

Enrollment: 240 patients

Sex: Female

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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240 participants in 2 patient groups

misoprostol

Experimental group

Description:

intrauterine 400 microgram

Treatment:

Drug: Misoprostol

oxytocin

Active Comparator group

Description:

intravenous infusion 10 units

Treatment:

Drug: Oxytocin