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

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.

Study Overview

• Status: Completed
• Conditions: Labor; Forced or Induced, Affecting Fetus or Newborn
• Intervention / Treatment: Drug: Misoprostol

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.

• Study Type: Interventional
• Enrollment (Actual): 243
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Single Dose; single dose of misoprostol	Drug: 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.; Other Names: cytotec, methotrexate
Active Comparator: Multiple Dose; multiple doses of misoprostol	Drug: 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.; Other Names: cytotec, methotrexate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Vaginal Delivery Within 24 Hours	To compare the rate of vaginal delivery within 24 hours in patients who receive a single dose of misoprostol versus those receiving multiple doses of this medication.	within 24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To Determine the Interval From Initiation of Misoprostol to Delivery in Each Group	To determine the interval from initiation of misoprostol to delivery in each group	within 24 hours from the initial intervention

Collaborators and Investigators

• Sponsor: Montefiore Medical Center
• Investigators: Principal Investigator: Pamela Tropper, MD, Montefiore Medical Center

Study record dates

Study Major Dates

• Study Start: February 1, 2016
• Primary Completion (Actual): May 17, 2017
• Study Completion (Actual): June 16, 2021

Study Registration Dates

• First Submitted: January 22, 2016
• First Submitted That Met QC Criteria: February 8, 2016
• First Posted (Estimate): February 11, 2016

Study Record Updates

• Last Update Posted (Actual): September 14, 2022
• Last Update Submitted That Met QC Criteria: August 19, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: unripe cervix
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Antirheumatic Agents; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Gastrointestinal Agents; Dermatologic Agents; Reproductive Control Agents; Anti-Ulcer Agents; Abortifacient Agents, Nonsteroidal; Abortifacient Agents; Folic Acid Antagonists; Oxytocics; Methotrexate; Misoprostol
• Other Study ID Numbers: 2015-5341

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes