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.

Trial Health

At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Enrollment

309

participants targeted

Target at P75+ for not_applicable obesity

Timeline

Completed

Started Sep 2015

Longer than P75 for not_applicable obesity

Geographic Reach

1 country

7 active sites

Status

unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

6 years study duration

Study Start

First participant enrolled

September 1, 2015

Completed

6 months until next milestone

First Submitted

Initial submission to the registry

February 16, 2016

Completed

3 days until next milestone

First Posted

Study publicly available on registry

February 19, 2016

Completed

4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2020

Completed

1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2021

Completed

Last Updated

September 13, 2016

Status Verified

September 1, 2016

Enrollment Period

5 years

First QC Date

February 16, 2016

Last Update Submit

September 12, 2016

Conditions

Obesity Infection; Cesarean Section Surgical Wound

Outcome Measures

Primary Outcomes (1)

Wound Complications
6 months

Study Arms (3)

Low Transverse

NO INTERVENTION

Patients in this arm will undergo their cesarean section using the standard low transverse skin incision location

Midline Vertical

EXPERIMENTAL

Patients in this arm will undergo their cesarean section using a midline vertical skin incision

Procedure: Midline Vertical

High Transverse

EXPERIMENTAL

Patients in this arm will undergo their cesarean section using a high transverse skin incision, above the pannus

Procedure: High Transverse

Interventions

Midline VerticalPROCEDURE

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

Midline Vertical

High TransversePROCEDURE

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

High Transverse

Eligibility Criteria

Sexfemale

Healthy VolunteersYes

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

pre-pregnancy BMI equal or greater than 40

You may not qualify if:

prior cesarean section or laparotomy

Contact the study team to confirm eligibility.