Labor Induction With Misoprostol Versus Oxytocin in Women With Premature Rupture of Membranes

sammour.rami

Status: Unknown

Conditions: Premature Rupture of Membrane; Prelabor Rupture of Membranes

Treatments: Drug: Misoprostol; Drug: Oxytocin

Study type: Interventional

Funder types: Other

Identifiers

NCT04143685

MISOX-001

Details and patient eligibility

About

This study compares the rate of vaginal delivery after induction of labor with misoprostol versus oxytocin in women with prelabor rupture of membranes. Participants will be randomized to receive either oral misoprotsol every four hours until going into labor, or intravenous oxytocin in increasing dose.

Full description

Misoprostol is a synthetic prostaglandin analogue commonly used for labor induction. It causes uterine contractions and ripening of the cervix. Oxytocin sold under the brand name Pitocin among others, is a medication made from the peptide oxytocin and is used to cause contraction of the uterus to start labor.

This randomized controlled trial will compare induction of labor in women with term premature rupture of the membranes and unripe cervix using misoprostol versus oxytocin. The primary outcome is the rate of vaginal delivery. Secondary outcomes will include cesarean section rate, time interval from induction of labor to delivery, neonatal morbidity, patient satisfaction and side effects, as well as chorioamnionitis.

Enrollment: 200 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Women in their 1st - 4th delivery
• Term prelabor rupture of membranes (37+0 to 42+0 gestational age)
• Vertex presentation
• Singleton pregnancy

Exclusion criteria

• Multiple pregnancy
• Previous cesarean section
• Chorioamnionitis on admission
• >2 symptomatic uterine contractions in 10 minutes
• Prostaglandins hypersensitivity
• Contraindication for vaginal delivery

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

misoprostol

Active Comparator group

Description:

misoprostol 50 mcg tablet by mouth every four hours for maximum dosage of six

Treatment:

Drug: Misoprostol

oxytocin

Active Comparator group

Description:

Oxytocin 10 IU in 1000 mL Standard solution. Starting with 10 mL/hr infusion rate and increasing by 10mL/hr every 20 minutes until achieving 3-5 regular uterine contractions every 10 minutes (as recorded by cardiotocography)

Treatment:

Drug: Oxytocin