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

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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

Tracking Information
First Submitted Date  ICMJE February 22, 2018
First Posted Date  ICMJE November 20, 2018
Last Update Posted Date November 20, 2018
Estimated Study Start Date  ICMJE December 10, 2018
Estimated Primary Completion Date June 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 19, 2018)
Vaginal delivery [ Time Frame: Variable, but within 4 days ]
Successful induction defined as a vaginal delivery following labor induction.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: November 19, 2018)
  • 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).
  • 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.
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cervical Ripening in Obese Women: Efficacy of 25 mcg Versus 50 mcg of Misoprostol
Official Title  ICMJE Cervical Ripening in Obese Women: a Prospective, Randomized Trial Comparing Efficacy of 25 mcg Versus 50 mcg of Misoprostol
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Induction of Labor Affected Fetus / Newborn
Intervention  ICMJE Drug: Misoprostol
prostaglandin e1
Other Name: cytotec
Study Arms  ICMJE
  • Active Comparator: Control
    Standard of care, misoprostol 25 mcg po every four hours
    Intervention: Drug: Misoprostol
  • Experimental: Intervention
    Misoprostol 50 mcg po every four hours
    Intervention: Drug: Misoprostol
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: November 19, 2018)
300
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 1, 2021
Estimated Primary Completion Date June 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Gender Eligibility Description: Pregnancy, Study of labor induction
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
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
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03748147
Other Study ID Numbers  ICMJE 2016-4435
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Plan Description: Would consider upon request.
Responsible Party Carri Warshak, University of Cincinnati
Study Sponsor  ICMJE University of Cincinnati
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Cincinnati
Verification Date November 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP