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

Last updated: January 27, 2020
Sponsor: sammour.rami
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT04143685
MISOX-001
  • Ages > 18
  • Female
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • Multiple pregnancy

  • Previous cesarean section

  • Chorioamnionitis on admission

  • >2 symptomatic uterine contractions in 10 minutes

  • Prostaglandins hypersensitivity

  • Contraindication for vaginal delivery

Study Design

Total Participants: 200
Study Start date:
December 01, 2019
Estimated Completion Date:
October 01, 2021

Study 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.

Connect with a study center

  • Bnai Zion Medical Center

    Haifa,
    Israel

    Active - Recruiting

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