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

NCT02680314 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 243

Last updated 2022-09-14

Study results available
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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

Interventions

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.

Sponsors & Collaborators

  • Montefiore Medical Center

    lead OTHER

Principal Investigators

  • Pamela Tropper, MD · Montefiore Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-02-29
Primary Completion
2017-05-17
Completion
2021-06-16
FDA Drug
Yes

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Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02680314 on ClinicalTrials.gov