An interventional study of Abdominal Pannus Retraction in Birth Length and Severe Obesity, sponsored by Medical College of Wisconsin. Not yet recruiting at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-09.
Sponsored by Medical College of Wisconsin · Not applicable, Interventional, and Treatment
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.
Maternal obesity is one of the most important contributors to pregnancy complications such as cesarean delivery and hemorrhage in Wisconsin, representing a growing public health challenge. According to the Wisconsin Department of Health Services, approximately 28% of women entering pregnancy have obesity, and the prevalence of maternal obesity and other disease comorbidities has steadily increased. As the number of pregnancies complicated by obesity continue to rise, so does those complicated by severe obesity (body mass index / BMI > 40), so does the burden of prolonged labor and significant maternal morbidity including cesarean delivery, postpartum hemorrhage, wound complications, infection, and blood clots. These complications increase healthcare utilization, hospitalization, and contribute to persistent maternal morbidity across Wisconsin. Froedtert and the Medical College of Wisconsin Birth Center serve as one of southeastern Wisconsin's largest tertiary obstetric referral centers, (including transfers for obesity due to increased delivery risk), providing care for a large and medically complex obstetric population. In 2025 alone, approximately 4,100 deliveries occurred at the Birth Center, and more than half (60%) of pregnant patients were complicated by obesity and/or obesity-related medical conditions. Our birth center is the ideal environment to evaluate interventions intended to improve labor outcomes among pregnant patients with obesity. One of the greatest challenges during childbirth for patients with obesity is an abnormal labor, in which cervical dilation progresses more slowly than expected or does not progress despite appropriate medical management.7-27 Compared with patients without obesity, patients with obesity are significantly more likely to experience an abnormal labor time, challenge with movement and monitoring of the child's welling being, require longer labor augmentation with more medication, have a failed induction of labor, require cesarean delivery, and ultimately suffer more labor complications such as hemorrhage.
Although obesity is one of the most common pregnancy complications encountered in obstetric practice, clinicians have minimal evidence-based interventions designed to address the slower labor progression that has been attributed to obesity. There has been increasing presence on social media platforms, particularly TikTok, regarding the use of abdominal pannus elevation/retraction during labor as a strategy to facilitate fetal descent and vaginal birth. Although this technique has generated substantial anecdotal interest among clinicians and influencers, there is limited published evidence evaluating its effectiveness in labor despite it being a simple bedside intervention used in ultrasound and to facilitate cesarean delivery. By elevating the abdominal soft tissue in patients with obesity, pannus retraction may also improve labor biomechanics by reducing pressure on the gravid uterus and fetal presenting part, thereby facilitating the cardinal movements of labor including appropriate cervical dilation, fetal descent, and rotation and ultimately vaginal delivery. Despite its clinical use for ultrasound and cesarean delivery, notably with high patient and provider satisfaction, abdominal pannus retraction has never been rigorously evaluated in a randomized clinical trial during childbirth.
This project directly addresses an important gap in maternal healthcare by evaluating whether standardized abdominal pannus retraction can safely improve labor progression among patients with severe obesity and reduce maternal complications such as cesarean delivery and hemorrhage. Because the intervention is inexpensive and already utilized into clinical care for cesarean delivery, even modest improvements in labor progression, time or reduction in cesarean delivery could improve maternal outcomes while reducing healthcare utilization, clinician injury, and/or costs throughout Wisconsin. The knowledge generated from this pilot study will provide the preliminary evidence necessary to design a larger efficacy trial and position Wisconsin to be at the forefront of improving childbirth among patients with obesity.
The overall goal of this project is to determine whether a randomized clinical trial evaluating standardized abdominal pannus retraction during labor and delivery is feasible while generating preliminary evidence regarding its effects on labor progression and maternal outcomes. During the 12-month project period, 100 pregnant patients with singleton, cephalic pregnancies at 37 weeks' gestation or greater, a body mass index of at least 40 kg/m² will be enrolled.
Following informed consent, participants will be randomly assigned in a 1:1 to receive either routine obstetric care alone (control arm) or routine obstetric care combined with standardized abdominal pannus retraction (intervention arm) using the Panni XL device. The intervention will continue until delivery. The primary clinical outcome will be the time from randomization to delivery. Secondary outcomes will include time to complete cervical dilation, duration of the second stage of labor, mode of delivery, oxytocin utilization, postpartum hemorrhage, maternal complications such as wound infection, neonatal outcomes, patient satisfaction, and multidisciplinary provider (i.e. nursing, obstetrician, midwife) acceptability. An equally important objective of this pilot study is to determine whether a larger randomized trial can be successfully conducted. Feasibility will be evaluated by measuring participant recruitment, enrollment, intervention adherence, protocol completion, provider compliance, participant tolerability, and safety. These findings will provide critical information for designing a future adequately powered multicenter clinical trial.
941 studies on the registry are indexed under Obesity, Morbid; 163 are open to participants now.
This study's planned enrollment of 100 is above the median of 62 across 602 interventional studies indexed under Obesity, Morbid.
Browse Obesity, Morbid studies →Medical College of Wisconsin is the lead sponsor of 548 studies on the registry; 122 are open to participants now.
Of its 75 completed or terminated interventional studies of FDA-regulated products, 57 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Other: Standard obstetric care at discretion of delivery provider Route obstetric care at discretion of delivery provider
Device: Panni XL Abdominal pannus elevation/ retraction during course of active labor
Device: Abdominal Pannus Retraction
Panni® XL will be used to provide abdominal pannus retraction from the time of informed consent through the entire duration of labor and delivery
Also known as: Abdominal Pannus Elevation, Abdominal Pannus Support, Panni XL
Time from randomization to delivery
Time frame: From randomization at the start of labor through delivery (typically within 48 hours after randomization
Time from randomization to complete cervical dilation
Time frame: From randomization to the first documentation of complete cervical dilation (10 cm), assessed for up to approximately 48 hours after randomization.
Duration of the second stage of labor
Time frame: From complete cervical dilation (10 cm) to birth, assessed for up to approximately 12 hours after complete dilation.
Mode of delivery
Will capture if delivery resulted in a vaginal birth or a cesarean section
Time frame: At delivery
Oxytocin utilization
Collect data of Oxytocin (Pitocin) as a labor augmentation agent
Time frame: From labor until birth.
Number of individuals with at least one composite postpartum hemorrhage morbidity
Birthing people who experience one or more of the following events will be counted once, regardless of the number of events experienced: Estimated blood loss \>1000 milliliters (mL), adminsitration of uterotonics, transexamic acid, blood transfusion, or surgical interventions (dilation and curettage, Bakri, Jadha, laparotomy, interventional radiology)
Time frame: From birth through 72 hours after birth
Number of birthing people with at least one maternal complications
Number maternal complicaitons defined as counts for wound infection, endometritis, and thromboembolism.
Time frame: From birth through 72 hours after birth
Number of neonates with at least one composite neonatal morbidity
Neonates who experience one or more of the following events will be counted once, regardless of the number of events experienced: NICU admission, seizures, hypoxic-ischemic encephalopathy, intracranial hemorrhage, electrolyte abnormalities, hypoglycemia, hyperbilirubinemia, hypothermia, hyperthermia, sepsis, and antibiotic administration
Time frame: From birth through 72 hours after birth
Patient satisfaction measured by Childbirth Experience Questionaire (CEQ2)
Childbirth experience will be assessed using the Childbirth Experience Questionnaire version 2.0 (CEQ 2.0), a 25-item questionnaire covering four domains: own capacity, professional support, perceived safety, and participation. Participants will complete the questionnaire after birth prior to discharge from th ehopsitals. The total score is calculated as the mean score across the questionnaire items and ranges from 1 to 4. Higher scores indicate a more positive childbirth experience.
Time frame: Once after birth, within 48 hours of delivery.
Provider-rated acceptability of abdominal pannus retraction on the Acceptability of Intervention Measure (AIM)
Acceptability of standardized Panni XL abdominal pannus retraction during labor will be assessed among nursing and obstetric providers using the four-item Acceptability of Intervention Measure (AIM). The mean of the four item responses will be calculated, with scores ranging from 1 to 5. Higher scores indicate greater acceptability.
Time frame: Once within 24 hours after the participant's delivery.
Provider-rated appropriateness of abdominal pannus retraction on the Intervention Appropriateness Measure (IAM)
Perceived appropriateness of standardized Panni XL abdominal pannus retraction during labor will be assessed among nursing and obstetric providers using the four-item Intervention Appropriateness Measure (IAM). The mean of the four item responses will be calculated, with scores ranging from 1 to 5. Higher scores indicate greater perceived appropriateness.
Time frame: Once within 24 after the participant's delivery.
Provider-rated feasibility of abdominal pannus retraction on the Feasibility of Intervention Measure (FIM)
Perceived feasibility of standardized Panni XL abdominal pannus retraction during labor will be assessed among nursing and obstetric providers using the four-item Feasibility of Intervention Measure (FIM). The mean of the four item responses will be calculated, with scores ranging from 1 to 5. Higher scores indicate greater perceived feasibility.
Time frame: Once within 24 after the participant's delivery.
Plan to share: No — IPD may be provided on a case by case basis, inquiries should be directed towards the study PI.
No publications or documents are linked to this record.
Start is estimated for Jan 2027; primary completion for Jan 2028, 12 months later.
Of 274 non-industry interventional studies with no phase under Obesity, Morbid, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 48. This study's planned 12 months is below that.
Counting every sponsor, half of 286 studies reached it within 25 months; a quarter within 11 and three quarters within 48.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Medical College of Wisconsin →