Obesity: Cesarean Health by Incision Placement

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

284 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-30

Study Completion Date

2019-09-30

Brief Summary

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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).

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Detailed Description

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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

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Maternal Morbidity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Pfannenstiel Incision

This curved incision is approximately 10-15 cm long and 2 cm above the pubic symphysis. If a pannus is present, the pannus should be retracted up (see diagram) to allow placement of the Pfannenstiel incision.

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

Cohen Incision

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

16 Years

Maximum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes