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

Primary Purpose

Maternal Morbidity

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cohen Incision
Sponsored by
Thomas Jefferson University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Maternal Morbidity

Eligibility Criteria

16 Years - 55 Years (Child, Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Thomas Jefferson University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Pfannenstiel Incision

Cohen Incision

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
September 16, 2016
Last Updated
July 9, 2018
Sponsor
Thomas Jefferson University
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1. Study Identification

Unique Protocol Identification Number
NCT02909582
Brief Title
Obesity: Cesarean Health by Incision Placement
Acronym
O-CHIP
Official Title
Obesity: Cesarean Health by Incision Placement
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Unknown status
Study Start Date
September 2016 (undefined)
Primary Completion Date
September 2019 (Anticipated)
Study Completion Date
September 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Thomas Jefferson University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Maternal Morbidity

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
284 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pfannenstiel Incision
Arm Type
No Intervention
Arm Description
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.
Arm Title
Cohen Incision
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Cohen Incision
Intervention Description
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 Information:
Title
Composite Maternal Morbidity
Description
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.
Time Frame
18 months
Secondary Outcome Measure Information:
Title
Composite maternal morbidity (as above) by stage of pannus
Time Frame
18 months
Title
Composite wound complication rates (cellulitis, wound abscess, wound separation or dehiscence, hematoma, seroma)
Time Frame
18 months
Title
Length in minutes of operative time from time of skin incision to time of delivery of the neonate
Time Frame
18 months
Title
Length in minutes of total operating time (from time of skin incision to the completion of closure of the skin incision)
Time Frame
18 months
Title
Patient satisfaction (via two questions, Likert scale)
Time Frame
18 months
Title
Severity of pain (via Likert scale) and amount of pain medications utilized in the first 48 hours post procedure
Time Frame
18 months
Title
Estimated blood loss (in milliliters)
Time Frame
18 months
Title
Incidence of low transverse uterine incisions (hysterotomy) with all other types of uterine incisions (vertical, high transverse, etc).
Time Frame
18 months
Title
Attending surgeon satisfaction (on 1-10 Likert scale) with feasibility of surgery by incision type
Time Frame
18 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rebekah McCurdy, MD
Phone
215-955-9200
Email
Rebekah.McCurdy@jefferson.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Laura Felder, MD
Phone
215-955-9200
Email
Laura.Felder@jefferson.edu
Facility Information:
Facility Name
Thomas Jefferson University Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rebekah McCurdy, MD
Phone
215-955-9200
Email
Rebekah.McCurdy@jefferson.edu

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
19879392
Citation
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.
Results Reference
background
PubMed Identifier
17716296
Citation
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.
Results Reference
background
PubMed Identifier
25457856
Citation
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.
Results Reference
background
PubMed Identifier
10819819
Citation
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.
Results Reference
background
PubMed Identifier
14672469
Citation
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.
Results Reference
background
PubMed Identifier
20678746
Citation
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.
Results Reference
background
PubMed Identifier
24560557
Citation
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.
Results Reference
background

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Obesity: Cesarean Health by Incision Placement

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