Obesity: Cesarean Health by Incision Placement

Study Overview
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Brief Summary
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Hypothesis: A Pfannenstiel cesarean skin incision placed under the pannus (should a pannus exist) will have a higher maternal morbidity composite rate than a Cohen cesarean skin incision placed above the pannus (should a pannus exist).

Detailed Description
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Introduction: Obesity affects approximately 1/3rd of all reproductive-aged women and is associated with increased maternal morbidity during and after cesarean section. The optimal surgical approach has not been well elucidated for obese individuals. Materials and Methods: This is a randomized controlled trial comparing a Pfannenstiel incision placed below the pannus (should a pannus exist) with a Cohen incision placed above the pannus (should a pannus exist); allocation is 1:1 with stratification for pre-gestational diabetes and presence of pannus. The study will be assessed by intention-to-treat analysis looking composite maternal morbidity (wound complications within 6 weeks, endometritis, postpartum hemorrhage) as the primary outcome with secondary outcomes including wound complications, operative time, estimated blood loss, pain management, and patient and surgeon satisfaction. Significant confounders will be assessed and adjusted in the multiple regression analysis accordingly. Results: The investigators propose the Cohen cesarean incision will result in statistically less maternal morbidity from cesarean section than the Pfannenstiel incision. Comment: The benefits of a Cohen incision have been encouraged in non-obese pregnant women; the investigators propose that they be considered in obese women as well.

Official Title
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Obesity: Cesarean Health by Incision Placement

Conditions
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Maternal Morbidity

Intervention / Treatment
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* Procedure: Cohen Incision


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: BMI > or = 35 kg/m2 at time of presentation for delivery Speaks English Exclusion Criteria: BMI < 35 kg/m2 at time of presentation or delivery Unable to consent (including language spoken other than English) Prior abdominal incisions or obstetric factors necessitating placement of incision in specified location, at the discretion of the attending surgeon Infection present (ie cellulitis) precluding incision placement at one of the randomization sites

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Pfannenstiel Incision<br>This curved incision is approximately 10-15 cm long and 2 cm above the pubic symphysis. If a pannus is present, the pannus should be retracted up (see diagram) to allow placement of the Pfannenstiel incision. | |
| Experimental: Cohen Incision<br>This is a straight transverse incision through the skin, 3 cm below the level of the anterior superior iliac spines (higher than the Pfannenstiel incision). Should a pannus exist, the pannus should be left in the physiologic location (not retracted) to allow placement of the incision. | Procedure: Cohen Incision<br>* This is a straight transverse incision through the skin, 3 cm below the level of the anterior superior iliac spines (higher than the Pfannenstiel incision). Should a pannus exist, the pannus should be left in the physiologic location (not retracted) to allow placement of the incision.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite Maternal Morbidity | To compare composite maternal morbidity (wound complications within 6 weeks including cellulitis, wound abscess, wound separation or dehiscence, hematoma, seroma formation, endometritis, postpartum hemorrhage), by placement type of transverse Cesarean skin incision in individuals with BMI >35 kg/m2. | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite maternal morbidity (as above) by stage of pannus |  | 18 months | 
| Composite wound complication rates (cellulitis, wound abscess, wound separation or dehiscence, hematoma, seroma) |  | 18 months | 
| Length in minutes of operative time from time of skin incision to time of delivery of the neonate |  | 18 months | 
| Length in minutes of total operating time (from time of skin incision to the completion of closure of the skin incision) |  | 18 months | 
| Patient satisfaction (via two questions, Likert scale) |  | 18 months | 
| Severity of pain (via Likert scale) and amount of pain medications utilized in the first 48 hours post procedure |  | 18 months | 
| Estimated blood loss (in milliliters) |  | 18 months | 
| Incidence of low transverse uterine incisions (hysterotomy) with all other types of uterine incisions (vertical, high transverse, etc). |  | 18 months | 
| Attending surgeon satisfaction (on 1-10 Likert scale) with feasibility of surgery by incision type |  | 18 months |