Skin Incisions and Wound Complication Rates for C-sections in Obese Women

Randomized Controlled Trial of Wound Complication Rates Between Low Transverse, Midline Vertical, and High Transverse Skin Incisions in Women With a BMI of 40 or Above Undergoing a Cesarean Section for Delivery

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02685761

Enrollment

309

Registered

2016-02-19

Start date

2015-09-30

Completion date

2021-09-30

Last updated

2016-09-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infection; Cesarean Section, Obesity, Surgical Wound

Brief summary

It is the purpose of this study to evaluate the relationship between a low transverse, vertical midline, and supra-panicular high transverse skin incisions and the rate of wound complications in women with a BMI of 40 or greater undergoing a cesarean section for delivery. So far, the choice of incision for the morbidly obese is based only on case reports. No randomized controlled trials have been done up to date comparing these methods. It is our hope that a high transverse incision will have all of the benefits of a low transverse skin incision, with the added benefit of better exposure offered by a vertical midline incision, without the added increased risk of subjecting the woman to a vertical hysterotomy.

Interventions

PROCEDUREMidline Vertical

Cesarean section performed using a midline vertical skin incision, located between the umbilicus and pubis

PROCEDUREHigh Transverse

Cesarean section performed using a transverse skin incision located above the pannus

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

FEMALE

Healthy volunteers

Yes

Inclusion criteria

* pre-pregnancy BMI equal or greater than 40

Exclusion criteria

* prior cesarean section or laparotomy

Design outcomes

Primary

Measure	Time frame
Wound Complications	6 months

Countries

United States

Contacts

Primary ContactPeter R Cole, MD

colep@mail.amc.edu518-262-4942

Backup ContactOlga T Filippova, MD

filippo@mail.amc.edu845-661-5716

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026