- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03796416
Obesity Study to Assess Induction of Labor (Obtainable)
Obesity Study to Assess Induction of Labor With Balloon and Cytotec: a Randomized Control Trial
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: misoprostol
Induction using misoprostol: Insert misoprostol 25 micrograms in the posterior fornix of the vagina digitally Repeat cervical exam every 4 hours |
used at a rate of 25 mcg Q4hours for cervical ripening.
|
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. |
used at a rate of 25 mcg Q4hours for cervical ripening.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
achieving complete cervical dilation
Time Frame: 24 hours
|
24 hours
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HP-00077208
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Induction of Labor Affected Fetus / Newborn
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Wake Forest University Health SciencesCompletedInduction of Labor Affected Fetus / NewbornUnited States
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Rambam Health Care CampusCompletedInduction of Labor Affected Fetus / NewbornIsrael
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Intermountain Health Care, Inc.Ferring PharmaceuticalsTerminatedInduction of Labor Affected Fetus / NewbornUnited States
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Ascension Genesys HospitalCompletedInduction of Labor Affected Fetus / NewbornUnited States
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Ain Shams Maternity HospitalUnknownInduction of Labor Affected Fetus / NewbornEgypt
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Ain Shams Maternity HospitalDr. Ahmed S. Abd El-Hameed; Prof. Abdel-Megeeed I. Abdel- MegeeedCompletedInduction of Labor Affected Fetus / NewbornEgypt
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Ain Shams UniversityCompletedInduction of Labor Affected Fetus / Newborn
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Hawaii Pacific HealthRecruitingInduction of Labor Affected Fetus / NewbornUnited States
Clinical Trials on Misoprostol
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Aljazeera HospitalKasr El Aini HospitalUnknown
-
Hospital de Clinicas de Porto AlegreCompletedMiscarriage in First TrimesterBrazil
-
Ferring PharmaceuticalsCompletedCervical Ripening | Labor InductionUnited Kingdom
-
Cairo UniversityCompleted
-
Medstar Health Research InstituteSociety of Family PlanningCompletedSecond Trimester AbortionsUnited States
-
Karolinska InstitutetCompletedFirst Trimester Pregnancy | Surgical Termination of PregnancySweden
-
CHA UniversityCompleted
-
Wenzhou Medical UniversityUnknown
-
University of Texas Southwestern Medical CenterCompleted
-
Rajavithi HospitalCompletedTo Compare Efficacy Intrauterine vs Sublingual MISOPROSTOL in Addition to Oxytocin in Reducing Blood Loss of Post-cesarean Section in High Risk WomenThailand