Obesity: Cesarean Health by Incision Placement

Not Applicable

• Conditions: Maternal Morbidity
• Interventions: Procedure: Cohen Incision

• Registration Number: NCT02909582
• Lead Sponsor: Thomas Jefferson University

Brief 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.

Study Timeline

• Study Start: 2016-09
• Study First Submitted: 2016-09-16
• Study First Submitted QC: 2016-09-16
• Study First Posted: 2016-09-21
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-09
• Last Update Posted: 2018-07-10
• Primary Completion: 2019-09
• Study Completion: 2019-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 284

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohen Incision	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.

Primary Outcome Measures

Name	Time	Method
Composite Maternal Morbidity	18 months	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.

Secondary Outcome Measures

Name	Time	Method
Attending surgeon satisfaction (on 1-10 Likert scale) with feasibility of surgery by incision type	18 months
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 total operating time (from time of skin incision to the completion of closure of the skin incision)	18 months
Estimated blood loss (in milliliters)	18 months
Patient satisfaction (via two questions, Likert scale)	18 months
Incidence of low transverse uterine incisions (hysterotomy) with all other types of uterine incisions (vertical, high transverse, etc).	18 months
Length in minutes of operative time from time of skin incision to time of delivery of the neonate	18 months
Severity of pain (via Likert scale) and amount of pain medications utilized in the first 48 hours post procedure	18 months

Trial Locations

Locations (1)

Thomas Jefferson University Hospital; 🇺🇸 Philadelphia, Pennsylvania, United States