Oxytocin Versus, Sublingual Misoprostol in the Secondary Prevention of Postpartum Hemorrhage After Vaginal Delivery

Not Applicable

• Conditions: Labor Complication
• Interventions: Drug: misoprostol; Drug: oxytocin

• Registration Number: NCT05077540
• Lead Sponsor: Aswan University Hospital

Brief Summary

Researchers sought to see how oxytocin versus, sublingual misoprostol affected estimated and measured blood loss during vaginal delivery in women who had blood loss \>300 ml .

Detailed Description

The greatest cause of maternal mortality globally is postpartum hemorrhage (PPH), which is defined as a blood loss of 500 mL or more after birth. All women giving birth should be given a preventive uterotonic drug, according to the World Health Organization (WHO).

Despite the use of a uterotonic drug as a preventative measure, PPH remains a frequent complication, accounting for one-quarter of all maternal fatalities worldwide. When prophylaxis fails and PPH develops, it is advised that uterotonic medicines be used as first-line therapy. However, it's unclear whether the uterotonic drug is better for treating PPH as first-line therapy.

Study Timeline

• Status Verified: 2021-10
• Study First Submitted: 2021-10-01
• Study First Submitted QC: 2021-10-01
• Study First Posted: 2021-10-14
• Last Update Submitted: 2021-10-14
• Last Update Posted: 2021-10-22
• Study Start: 2021-11-01
• Primary Completion: 2023-10-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 150

Inclusion Criteria

• vaginal birth in women who had blood loss >300 ml

Exclusion Criteria

• <37 weeks of pregnancy,
• genital tract injuries,
• coagulation deficit,
• hypertension, preeclampsia,
• cardiac, renal, or hepatic disease,
• epilepsy,

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
misoprostol	misoprostol	800 µg sublingual misoprostol (Cytotec Pfizer, New York, USA)
oxytocin	oxytocin	20 unit of oxytocin infusion in 500 ml lactated ringer's solution 125 ml/h (Syntocinon, Novartis, Switzerland)

Primary Outcome Measures

Name	Time	Method
measured excessive bleeding blood loss ≥ 300 mills after PPH treatment	24 hours	measured amount of blood loss ≥ 300 mills after PPH treatment

Secondary Outcome Measures

Name	Time	Method
change in hemoglobin	12 hours	measure change of hemoglobin
need for additional interventions	24 hours	number of patients need additional interventions ,like uterine aetry ligation