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Cervical Ripening in Obese Women: Efficacy of 25 mcg Versus 50 mcg of Misoprostol

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03748147
Recruitment Status : Not yet recruiting
First Posted : November 20, 2018
Last Update Posted : November 20, 2018
Sponsor:
Information provided by (Responsible Party):
Carri Warshak, University of Cincinnati

Brief Summary:
This is a prospective clinical trial to determine if 50 mcg versus 25 mcg po every four hours of misoprostol has improved efficacy and similar safety in obese women undergoing cesarean section.

Condition or disease Intervention/treatment Phase
Induction of Labor Affected Fetus / Newborn Drug: Misoprostol Not Applicable

Detailed Description:

We will perform a prospective, randomized, double-blind clinical trial with parallel assignment.

Obese women (delivery BMI 30 or more) who agree to participation will be randomly designated to receive either 25 mcg po q 4 hour (control) misoprosol versus 50 mcg po q 4 hours. Our primary outcome will be the rate of successful induction. Secondary outcomes will include ability to achieve a Bishop score greater than 7, time to active labor, and safety data including rate of tachysystole, non-reassuring fetal status, NICU admission.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: Parallel design randomized trial. Two study groups: control (25 mcg) intervention (50 mcg)
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: Both arms will receive identical appearing drug made by the Investigational Drug Unit of the Pharmacy.
Primary Purpose: Treatment
Official Title: Cervical Ripening in Obese Women: a Prospective, Randomized Trial Comparing Efficacy of 25 mcg Versus 50 mcg of Misoprostol
Estimated Study Start Date : December 10, 2018
Estimated Primary Completion Date : June 1, 2020
Estimated Study Completion Date : March 1, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Misoprostol

Arm Intervention/treatment
Active Comparator: Control
Standard of care, misoprostol 25 mcg po every four hours
Drug: Misoprostol
prostaglandin e1
Other Name: cytotec

Experimental: Intervention
Misoprostol 50 mcg po every four hours
Drug: Misoprostol
prostaglandin e1
Other Name: cytotec




Primary Outcome Measures :
  1. Vaginal delivery [ Time Frame: Variable, but within 4 days ]
    Successful induction defined as a vaginal delivery following labor induction.


Secondary Outcome Measures :
  1. Completed cervical ripening [ Time Frame: 2 days ]
    Bishop score of greater than 7 (Bishop score designated per protocol based upon cervical dilation, effacement, station, consistency and position).

  2. Specific time interval from start of induction to active labor [ Time Frame: 2 days ]
    We will measure the interval (hours) between start of cervical ripening and active labor defined as reaching a cervical dilation of 6 cm.

  3. Rate of tachysystole, fetal nonreassuring status, uterine rupture [ Time Frame: 3 days ]
    Rate of the following as categorical variables: tachysystole (any delay in study medication administration for greater than 5 contractions/10 minute window), non-reassuring fetal status (any evaluation of the fetal tracing that leads to delays in study drug administration secondary to concerns for the fetal status), NICU admission, uterine rupture



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
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Pregnancy, Study of labor induction
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Labor induction, BMI of 30 or greater, English speaking

Exclusion Criteria:

  • Prior cesarean section, uterine tachysystole (5 contractions/ 10 minutes) on admission, Contraindication to labor induction

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): NCT03748147


Contacts
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Contact: Carri R Warshak, M.D. 513-558-8448 eaglercr@ucmail.uc.edu
Contact: David McKinney, M.D. 513-558-8448 mckinndi@ucmail.uc.edu

Sponsors and Collaborators
University of Cincinnati
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Responsible Party: Carri Warshak, Associate Clinical Professor, University of Cincinnati
ClinicalTrials.gov Identifier: NCT03748147    
Other Study ID Numbers: 2016-4435
First Posted: November 20, 2018    Key Record Dates
Last Update Posted: November 20, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Would consider upon request.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
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