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Obesity Study to Assess Induction of Labor

Obesity Study to Assess Induction of Labor With Balloon and Cytotec: a Randomized Control Trial

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03796416
Acronym
Obtainable
Enrollment
0
Registered
2019-01-08
Start date
2019-12-01
Completion date
2025-07-31
Last updated
2022-03-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Induction of Labor Affected Fetus / Newborn

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.

Interventions

DRUGMisoprostol

used at a rate of 25 mcg Q4hours for cervical ripening.

Sponsors

University of Maryland, Baltimore
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
achieving complete cervical dilation24 hours

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026