Recruiting

Observational Study

Sponsor:

Thomas Jefferson University

Code:

NCT02909582

Conditions

Maternal Morbidity

Eligibility Criteria

Sex: Female

Age: 16 - 55

Healthy Volunteers: Accepted

Interventions

Cohen Incision

Study Details

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).

Conditions

Maternal Morbidity

Study ID

NCT02909582

Start date

Sep, 2016

Status verified date

Jul, 2018

Completion date

Sep, 2019

Anticipated

Primary completion date

Sep, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 16 - 55

Healthy Volunteers: Accepted

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

Enrollment

284 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

no intervention: 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.

experimental: 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.

Interventions

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 measure

  • Composite Maternal Morbidity [ Time Frame: 18 months ]

Central Contacts and Locations

Central contacts

Rebekah McCurdy, MD

215-955-9200Rebekah.McCurdy@jefferson.edu

Laura Felder, MD

215-955-9200Laura.Felder@jefferson.edu

Locations

Thomas Jefferson University Hospital

Recruiting

Philadelphia, Pennsylvania, United States, 19107

Contacts

Rebekah McCurdy, MD

215-955-9200Rebekah.McCurdy@jefferson.edu

More Information

Sponsor

Thomas Jefferson University

Last update posted

Jul 10, 2018

Last verified

Jul, 2018

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Thomas Jefferson University on 2018-07-10.