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

Premature Rupture of Membrane Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04143685
• Other study ID #: MISOX-001
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2019
• Est. completion date: October 1, 2021

Study information

• Verified date: October 2019
• Source: Bnai Zion Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: October 1, 2021
• Est. primary completion date: August 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fetal Membranes, Premature Rupture
• Prelabor Rupture of Membranes
• Premature Birth
• Premature Rupture of Membrane
• Rupture

Intervention

Drug:
• Misoprostol
Oral administration of cytotec every 4 hours until a maximum of 6 doses
• Oxytocin
Intravenous infusion of Pitocin through an IVAC until delivery

Locations

Country	Name	City	State
Israel	Bnai Zion Medical Center	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
sammour.rami

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vaginal delivery rate		During delivery
Secondary	Operative delivery rate, Cesarean section rate, time interval from induction of labor to delivery		During delivery
Secondary	chorioamnionitis rate	intra-amniotic infection during or after delivery representing in possible combination of maternal fever, fetal tachycardia, maternal leukocytosis, Histopathologic evidence of infection or inflammation or both in the placenta, fetal membranes, or the umbilical cord vessels	During or after delivery up to 7 days
Secondary	Uterine tachysystole		During delivery
Secondary	Neonatal morbidity	Apgar score, , ,	After delivery until discharge
Secondary	Neonatal morbidity	Umbilical Cord Blood Gases	immediately after delivery
Secondary	Neonatal morbidity	NICU admission	up to 7 days after delivery
Secondary	Neonatal morbidity	Antibiotic administration	up to 7 days after delivery