Obesity: Cesarean Health by Incision Placement



Status:Recruiting
Healthy:No
Age Range:16 - 55
Updated:7/12/2018
Start Date:September 2016
End Date:September 2019
Contact:Rebekah McCurdy, MD
Email:Rebekah.McCurdy@jefferson.edu
Phone:215-955-9200

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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).

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.

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
We found this trial at
1
site
111 S 11th St
Philadelphia, Pennsylvania 19107
(215) 955-6000
Phone: 215-955-9200
Thomas Jefferson University Hospital Our hospitals in Center City Philadelphia share a 13-acre campus with...
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mi
from
Philadelphia, PA
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