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

Aswan University Hospital

Status: Unknown

Conditions: Labor Complication

Treatments: Drug: misoprostol; Drug: oxytocin

Study type: Interventional

Funder types: Other

Identifiers

NCT05077540

aswu/543/8/21

Details and patient eligibility

About

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 .

Full 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.

Enrollment: 150 estimated patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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,

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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150 participants in 2 patient groups

oxytocin

Active Comparator group

Description:

20 unit of oxytocin infusion in 500 ml lactated ringer's solution 125 ml/h (Syntocinon, Novartis, Switzerland)

Treatment:

Drug: oxytocin

misoprostol

Experimental group

Description:

800 µg sublingual misoprostol (Cytotec Pfizer, New York, USA)

Treatment:

Drug: misoprostol