Obesity: Cesarean Health by Incision Placement

Maternal Morbidity Clinical Trial

— O-CHIP  

Official title:

Obesity: Cesarean Health by Incision Placement

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02909582
• Other study ID #: 16D.541
• Status: Recruiting
• Phase: N/A
• 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
• 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:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 284
• Est. completion date: September 2019
• Est. primary completion date: September 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 16 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Maternal Morbidity

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)

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. — View 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. Review. — View 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. Review. — View 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. Review. — View 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. — View 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. — View 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. — View Citation

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