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Obesity Study to Assess Induction of Labor (Obtainable)

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ClinicalTrials.gov Identifier: NCT03796416
Recruitment Status : Withdrawn (in error)
First Posted : January 8, 2019
Last Update Posted : October 19, 2020
Sponsor:
Information provided by (Responsible Party):
Sarah Crimmins, University of Maryland, College Park

Tracking Information
First Submitted Date  ICMJE January 4, 2019
First Posted Date  ICMJE January 8, 2019
Last Update Posted Date October 19, 2020
Actual Study Start Date  ICMJE December 1, 2019
Estimated Primary Completion Date January 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 4, 2019)
achieving complete cervical dilation [ Time Frame: 24 hours ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Obesity Study to Assess Induction of Labor
Official Title  ICMJE Obesity Study to Assess Induction of Labor With Balloon and Cytotec: a Randomized Control Trial
Brief Summary

There are more and more pregnant women who are obese. It is very difficult for obese women to get into labor. That is why when women are obese, half are likely to need a Cesarean delivery(C-section). Unfortunately, C-sections are more dangerous for obese women. There may be a combination of issues that cause obese women to need C-sections. We believe one of those reasons is that the womb of obese women respond differently to medications and devices compared to non-obese women. There are commonly two ways to help women get into labor. One way is a medication called misoprostol. The second way is a device called Foley balloon. In most studies, both ways are equally effective in helping women get into labor. However, these studies included everyone, and didn't focus on obese women.

So far there are no studies in this area that focus only on obese women. Therefore we need to design this study to focus just on obese women and what is the best way to help them get into labor and avoid a C-section.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Induction of Labor Affected Fetus / Newborn
Intervention  ICMJE Drug: Misoprostol
used at a rate of 25 mcg Q4hours for cervical ripening.
Study Arms  ICMJE
  • Active Comparator: misoprostol

    Induction using misoprostol:

    Insert misoprostol 25 micrograms in the posterior fornix of the vagina digitally Repeat cervical exam every 4 hours

    Intervention: Drug: Misoprostol
  • Experimental: Misoprostol and foley bulb

    Induction using Foley balloon combined with misoprostol:

    A 26 French intracervical Foley balloon will be inserted above the internal os at the start of induction, inflated using 80cc of sterile water.

    If a Foley balloon is not able to be inserted at the time of starting induction of labor, misoprostol 25microgram can be inserted in the posterior fornix of the vagina and the misoprostol protocol followed.

    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 Withdrawn
Actual Enrollment  ICMJE
 (submitted: October 13, 2020)
0
Original Estimated Enrollment  ICMJE
 (submitted: January 4, 2019)
400
Estimated Study Completion Date  ICMJE July 2025
Estimated Primary Completion Date January 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Morbidly obese patient (BMI≥40kg/m2) at admission for induction of labor Speaks English Gestational age between 37and0 weeks and 41and6 weeks Cervical exam: dilation <4cm and Bishop score 6 or less Contractions < 2 per 10 minutes

Exclusion Criteria:

  • History of cesarean delivery Maternal contraindications to labor Fetal contraindications to labor Maternal age <18yo Fetal growth restriction with abnormal umbilical artery Doppler indexes Cervical dilation ≥4cm or Bishop score ≥7 Contractions ≥3 per 10 minutes Non-reassuring fetal status Latex allergy
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03796416
Other Study ID Numbers  ICMJE HP-00077208
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Sarah Crimmins, University of Maryland, College Park
Study Sponsor  ICMJE University of Maryland, Baltimore
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Maryland, Baltimore
Verification Date October 2020

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