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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02909582
Other study ID # 16D.541
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 2016
Est. completion date September 2019

Study information

Verified date July 2018
Source Thomas Jefferson University
Contact Rebekah McCurdy, MD
Phone 215-955-9200
Email Rebekah.McCurdy@jefferson.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
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.

Locations

Country Name City State
United States Thomas Jefferson University Hospital Philadelphia Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
Thomas Jefferson University

Country where clinical trial is conducted

United States, 

References & Publications (7)

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Outcome

Type Measure Description Time frame Safety issue
Primary Composite Maternal Morbidity 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. 18 months
Secondary Composite maternal morbidity (as above) by stage of pannus 18 months
Secondary Composite wound complication rates (cellulitis, wound abscess, wound separation or dehiscence, hematoma, seroma) 18 months
Secondary Length in minutes of operative time from time of skin incision to time of delivery of the neonate 18 months
Secondary Length in minutes of total operating time (from time of skin incision to the completion of closure of the skin incision) 18 months
Secondary Patient satisfaction (via two questions, Likert scale) 18 months
Secondary Severity of pain (via Likert scale) and amount of pain medications utilized in the first 48 hours post procedure 18 months
Secondary Estimated blood loss (in milliliters) 18 months
Secondary Incidence of low transverse uterine incisions (hysterotomy) with all other types of uterine incisions (vertical, high transverse, etc). 18 months
Secondary Attending surgeon satisfaction (on 1-10 Likert scale) with feasibility of surgery by incision type 18 months
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