Maternal Morbidity Clinical Trial
Official title:
Obesity: Cesarean Health by Incision Placement
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.
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