Obesity: Cesarean Health by Incision Placement (O-CHIP)

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).

Study Overview

• Status: Unknown
• Conditions: Maternal Morbidity
• Intervention / Treatment: Procedure: Cohen Incision

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 284
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Recruiting
      • Thomas Jefferson University Hospital
      • Contact: Rebekah McCurdy, MD; Phone Number: 215-955-9200; Email: Rebekah.McCurdy@jefferson.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 51 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Thomas Jefferson University

Publications and helpful links

General Publications

• Hofmeyr JG, Novikova N, Mathai M, Shah A. Techniques for cesarean section. Am J Obstet Gynecol. 2009 Nov;201(5):431-44. doi: 10.1016/j.ajog.2009.03.018.
• Chu SY, Kim SY, Schmid CH, Dietz PM, Callaghan WM, Lau J, Curtis KM. Maternal obesity and risk of cesarean delivery: a meta-analysis. Obes Rev. 2007 Sep;8(5):385-94. doi: 10.1111/j.1467-789X.2007.00397.x.
• Ayres-de-Campos D. Obesity and the challenges of caesarean delivery: prevention and management of wound complications. Best Pract Res Clin Obstet Gynaecol. 2015 Apr;29(3):406-14. doi: 10.1016/j.bpobgyn.2014.08.009. Epub 2014 Oct 16.
• Houston MC, Raynor BD. Postoperative morbidity in the morbidly obese parturient woman: supraumbilical and low transverse abdominal approaches. Am J Obstet Gynecol. 2000 May;182(5):1033-5. doi: 10.1067/mob.2000.105400.
• Wall PD, Deucy EE, Glantz JC, Pressman EK. Vertical skin incisions and wound complications in the obese parturient. Obstet Gynecol. 2003 Nov;102(5 Pt 1):952-6. doi: 10.1016/s0029-7844(03)00861-5.
• Alanis MC, Villers MS, Law TL, Steadman EM, Robinson CJ. Complications of cesarean delivery in the massively obese parturient. Am J Obstet Gynecol. 2010 Sep;203(3):271.e1-7. doi: 10.1016/j.ajog.2010.06.049. Epub 2010 Aug 3.
• Marrs CC, Moussa HN, Sibai BM, Blackwell SC. REMOVED: The relationship between primary cesarean delivery skin incision type and wound complications in women with morbid obesity. Am J Obstet Gynecol. 2014 Apr;210(4):319. doi: 10.1016/j.ajog.2014.01.018. Epub 2014 Feb 20.

Study record dates

Study Major Dates

• Study Start: September 1, 2016
• Primary Completion (Anticipated): September 1, 2019
• Study Completion (Anticipated): September 1, 2019

Study Registration Dates

• First Submitted: September 16, 2016
• First Submitted That Met QC Criteria: September 16, 2016
• First Posted (Estimate): September 21, 2016

Study Record Updates

• Last Update Posted (Actual): July 10, 2018
• Last Update Submitted That Met QC Criteria: July 9, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity
• Other Study ID Numbers: 16D.541

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No