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

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ClinicalTrials.gov Identifier: NCT02680314
Recruitment Status : Unknown
Verified February 2016 by Montefiore Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : February 11, 2016
Last Update Posted : February 11, 2016
Sponsor:
Information provided by (Responsible Party):
Montefiore Medical Center

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.

Condition or disease Intervention/treatment Phase
Labor; Forced or Induced, Affecting Fetus or Newborn Drug: Misoprostol Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 350 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Is More Than One Dose of Misoprostol Needed to Expedite Vaginal Delivery in a Patient With an Unripe Cervix?
Study Start Date : February 2016
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : May 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Misoprostol

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 Name: 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 Name: cytotec, methotrexate




Primary Outcome Measures :
  1. 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. [ Time Frame: 24 hours ]

Secondary Outcome Measures :
  1. To determine the interval from initiation of misoprostol to delivery in each group [ Time Frame: within 24 hours from the initial intervention ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02680314


Contacts
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Contact: Pamela Tropper, MD 718.904.2767 ptropper@montefiore.org
Contact: Veronica Pimental, MD MS 718.904.2767 vpimente@montefiore.org

Sponsors and Collaborators
Montefiore Medical Center
Investigators
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Principal Investigator: Pamela Tropper, MD Montefiore Medical Center

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Responsible Party: Montefiore Medical Center
ClinicalTrials.gov Identifier: NCT02680314     History of Changes
Other Study ID Numbers: 2015-5341
First Posted: February 11, 2016    Key Record Dates
Last Update Posted: February 11, 2016
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Montefiore Medical Center:
unripe cervix
Additional relevant MeSH terms:
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Misoprostol
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Anti-Ulcer Agents
Gastrointestinal Agents
Oxytocics