Abdominal Pannus Retraction for Obesity During Labor

(IMPACT Trial)

Age: 18+
Sex: Female
Trial Phase: Academic
Sponsor: Medical College of Wisconsin
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

Pregnant patients with severe obesity sometimes experience longer duration labors and higher rate of cesarean delivery. This study is looking at whether gently lifting the abdominal tissues, the pannus, during active labor can help the labor process progress more efficiently.

Pregnant patients with severe obesity who are in active labor, anticipating a vaginal delivery will be randomly assigned into either a standard of care group or an interventional group. The interventional group with receive standard obstetric care and a medical device supporting/ lifting the abdominal pannus.

The final aims of this project will compare how long labor lasts, mode of delivery (vaginal or cesarean section), and other maternal health outcomes. This study will also evaluate to the comfort of the patient as well of the healthcare providers.

This overall goal of this clinical trial is to learn whether lifting the abdominal pannus is a practical and effective way to improve labor outcomes of obese pregnant patients. The knowledge gained will help guide future, larger studies.

Are You a Good Fit for This Trial?

This trial is for pregnant women with severe obesity who are in active labor and planning a vaginal delivery. Participants must be able to safely use the device that lifts the abdominal tissue during labor.

Inclusion Criteria

Gestational age of at least 37 weeks
Singleton pregnancy
Cephalic pregnancy
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Exclusion Criteria

Major fetal anomaly
Multiple gestation
Prelabor premature rupture of membranes before 36 weeks 0 days gestation
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What Are the Treatments Tested in This Trial?

Interventions

  • Abdominal Pannus Retraction

Trial Overview

The study tests whether gently lifting the lower belly (abdominal pannus) with a medical device during labor helps improve how quickly and smoothly labor progresses, compared to standard care alone. Participants are randomly assigned to either group.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Abdominal Pannus RetractionExperimental Treatment1 Intervention
Group II: Standard of CareActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Medical College of Wisconsin

Lead Sponsor

Trials
645
Recruited
1,180,000+