Uterotonics for Severe Preeclampsia

Assiut University

Status: Completed

Conditions: Preeclampsia Severe

Treatments: Drug: Carbetocin; Drug: Oxytocin; Drug: Misoprostol

Study type: Interventional

Funder types: Other

Identifiers

NCT04756661

CARBOXMISO

Details and patient eligibility

About

The study compares the effect of Intravenous carbetocin versus combined use of intravenous oxytocin and rectal misoprostol for prevention of postpartum hemorrhage during delivery of women with severe preeclampsia

Enrollment: 124 patients

Sex: Female

Volunteers: No Healthy Volunteers

Inclusion criteria

• Pregnant women which diagnosed with severe pre-eclampsia.
• Singleton pregnancy.
• Termination of pregnancy by Cesarean section after 28 weeks of gestation.

Exclusion criteria

• Suspected or proven placental abruption.
• Known placenta Previa or acreata.
• Multiple pregnancies.
• Obesity (BMI >35).
• Anemia (<9 g/dl).
• Retained placental tissues.
• Big baby (> 4 kg).
• Presence of coagulopathy.
• Polyhydramnios.
• Presence of Uterine fibroids.
• Medical diseases as; cardiac, liver, renal or endocrine diseases.
• General anesthesia.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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124 participants in 2 patient groups

Carbetocin

Experimental group

Description:

Patient received 100 mcg of carbetocin intravenous over one minute immediately after delivery of the baby.

Treatment:

Drug: Carbetocin

Oxytocin plus misoprostol

Active Comparator group

Description:

Patient received 10 units of oxytocin IV drip and 400 mcg of misoprostol rectally after anesthesia.

Treatment:

Drug: Oxytocin

Drug: Misoprostol