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OpenTrials
Completed

NCT Number: NCT02680314

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.

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: cytotec, methotrexate

Primary outcomes

  1. Number of Participants With Vaginal Delivery Within 24 Hours

    Time frame: 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.

Secondary outcomes

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

    Time frame: within 24 hours from the initial intervention

    To determine the interval from initiation of misoprostol to delivery in each group

Sponsors and collaborators

Lead sponsor

Montefiore Medical Center

Other

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2021
First posted
Feb 11, 2016
Registry last updated
Sep 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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