Is More Than One Dose of Misoprostol Needed to Expedite Vaginal Delivery in a Patient With an Unripe Cervix?

• Status: Completed
• Trial end date: 2021-06-16
• Target enrollment: 0
• Participant gender: Female

Summary

The goal of this study is to determine whether inducing labor with just one dose of misoprostol, followed by treatment with oxytocin, will still be effective enough to increase the chances of having a successful vaginal delivery as compared to using more than one dose of misoprostol, followed by treatment with oxytocin.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Montefiore Medical Center
• Treatments: Methotrexate; Misoprostol

Criteria

Inclusion Criteria:

• Any pregnant woman undergoing induction of labor

• Live singleton pregnancy ≥ 37 week gestation

• Bishop score < 6

• Category I fetal heart rate

Exclusion Criteria:

• Contraindications to vaginal delivery (e.g. vasa previa, placenta prevue,non-vertex presentation, umbilical cord prolapse, and active genital herpes infection.)

• Pregnancies complicated by major fetal anomalies

• Any contraindication to the use of misoprostol, including

• History of previous c-section or major uterine surgery

• Prior allergic reaction

• Category II or III fetal heart rate

• Regular uterine contractions ≥ 3 in a 10-minute period persistent for at least 30 minutes

• Estimated fetal weight < 10 percentile

• Premature rupture of membranes

• Age < 18 years old

• Women who do not have the capacity to consent