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

NCT ID: NCT02680314

Last Updated: 2022-09-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 243 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-02-29
• Study Completion Date: 2021-06-16

Brief 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.

Detailed Description

This study involves a comparison of two different regimens of prostaglandin use for "cervical ripening" prior to induction of labor. Women admitted to the hospital for induction of labor who are found to have "unripe" cervixes at the time of admission, and who agree to participate in the study will be randomly assigned to one of two treatment groups. In one group, a single dose of 25 µcg of misoprostol will be administered vaginally and four hours later oxytocin induction will be started if clinically indicated. In the second group of women, repeat doses of misoprostol will be given every four hours up to six doses unless labor or cervical ripening occurs sooner. At this point, oxytocin will be started as needed. Success of vaginal delivery by 24 hours, time from initiation of protocol to delivery and cesarean section rates will be compared. Complications such as postpartum hemorrhage, episodes of tachysystole with fetal compromise and chorioamnionitis and endometritis will be monitored.

Conditions

Labor; Forced or Induced, Affecting Fetus or Newborn

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Single Dose

single dose of misoprostol

Group Type: ACTIVE_COMPARATOR

Misoprostol

Intervention Type: DRUG

Misoprostol, a prostaglandin, binds to myometrial cells to cause strong myometrial contractions leading to expulsion of tissue. This agent also causes cervical ripening with softening and dilation of the cervix.

Multiple Dose

multiple doses of misoprostol

Group Type: ACTIVE_COMPARATOR

Misoprostol

Intervention Type: DRUG

Misoprostol, a prostaglandin, binds to myometrial cells to cause strong myometrial contractions leading to expulsion of tissue. This agent also causes cervical ripening with softening and dilation of the cervix.

Interventions

Misoprostol

Misoprostol, a prostaglandin, binds to myometrial cells to cause strong myometrial contractions leading to expulsion of tissue. This agent also causes cervical ripening with softening and dilation of the cervix.

Intervention Type: DRUG

Other Intervention Names

cytotec, methotrexate

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Montefiore Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Peter S. Bernstein

Prof., Maternal Fetal Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Pamela Tropper, MD

Role: PRINCIPAL_INVESTIGATOR

Montefiore Medical Center

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2015-5341

Identifier Type: -

Identifier Source: org_study_id