NCT02909582

Obesity: Cesarean Health by Incision Placement

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 284 (estimated)
• Sponsor: Thomas Jefferson University · Academic / Other
• Sex: Female
• Age: 16 Years – 55 Years
• Healthy volunteers: Accepted

Summary

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

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.

Conditions

• Maternal Morbidity

Interventions

Type	Name	Description
PROCEDURE	Cohen Incision	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.

Timeline

• Start date: 2016-09-01
• Primary completion: 2019-09-01
• Completion: 2019-09-01
• First posted: 2016-09-21
• Last updated: 2018-07-10

Locations

1 site across 1 country: United States