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

NCT02680314 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: 2015-5341
• Study Type: interventional
• Target: 243
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Labor; Forced or Induced, Affecting Fetus or Newborn

Keywords

unripe cervix

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• To Determine the Interval From Initiation of Misoprostol to Delivery in Each Group

  within 24 hours from the initial intervention

Study Arms (2)

Single Dose

ACTIVE COMPARATOR

single dose of misoprostol

Drug: Misoprostol

Multiple Dose

ACTIVE COMPARATOR

multiple doses of misoprostol

Drug: Misoprostol

Interventions

Misoprostol 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.

Also known as: cytotec, methotrexate

Multiple Dose; Single Dose

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Any pregnant woman undergoing induction of labor
• Live singleton pregnancy ≥ 37 week gestation
• Bishop score \< 6
• Category I fetal heart rate

You may not qualify if:

• 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

Sponsors & Collaborators

• Montefiore Medical Center: lead

MeSH Terms

Interventions

Misoprostol; Methotrexate

Intervention Hierarchy (Ancestors)

Prostaglandins E, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors; Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Peter Bernstein, MD
• Organization: Montefiore Medical Center

pbernste@montefiore.org

718-904-2767

Study Officials

• Pamela Tropper, MD

  Montefiore Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof., Maternal Fetal Medicine

Study Record Dates

• First Submitted: January 22, 2016
• First Posted: February 11, 2016
• Study Start: February 1, 2016
• Primary Completion: May 17, 2017
• Study Completion: June 16, 2021
• Last Updated: September 14, 2022
• Results First Posted: July 9, 2021

Record last verified: 2022-08