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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
284
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.
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States
RECRUITINGComposite 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.
Time frame: 18 months
Composite maternal morbidity (as above) by stage of pannus
Time frame: 18 months
Composite wound complication rates (cellulitis, wound abscess, wound separation or dehiscence, hematoma, seroma)
Time frame: 18 months
Length in minutes of operative time from time of skin incision to time of delivery of the neonate
Time frame: 18 months
Length in minutes of total operating time (from time of skin incision to the completion of closure of the skin incision)
Time frame: 18 months
Patient satisfaction (via two questions, Likert scale)
Time frame: 18 months
Severity of pain (via Likert scale) and amount of pain medications utilized in the first 48 hours post procedure
Time frame: 18 months
Estimated blood loss (in milliliters)
Time frame: 18 months
Incidence of low transverse uterine incisions (hysterotomy) with all other types of uterine incisions (vertical, high transverse, etc).
Time frame: 18 months
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Attending surgeon satisfaction (on 1-10 Likert scale) with feasibility of surgery by incision type
Time frame: 18 months