Obesity: Cesarean Health by Incision Placement

NCT02909582 | Unknown DMC

• 1 other identifier: 16D.541
• Study Type: interventional
• Target: 284
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• 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

Study Arms (2)

Pfannenstiel Incision

NO INTERVENTION

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.

Cohen Incision

EXPERIMENTAL

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

Interventions

Cohen Incision PROCEDURE

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.

Cohen Incision

Eligibility Criteria

• Age: 16 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• BMI \> or = 35 kg/m2 at time of presentation for delivery
• Speaks English

You may not qualify if:

• 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

Sponsors & Collaborators

• Thomas Jefferson University: lead

Study Sites (1)

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

RECRUITING

Related Publications (7)

• 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.

  PMID: 19879392 BACKGROUND

• 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.

  PMID: 17716296 BACKGROUND

• 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.

  PMID: 25457856 BACKGROUND

• 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.

  PMID: 10819819 BACKGROUND

• 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.

  PMID: 14672469 BACKGROUND

• 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.

  PMID: 20678746 BACKGROUND

• 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.

  PMID: 24560557 BACKGROUND

Central Study Contacts

Rebekah McCurdy, MD

CONTACT

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

Laura Felder, MD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Obstetrician/Maternal Fetal Medicine Fellow

Study Record Dates

• First Submitted: September 16, 2016
• First Posted: September 21, 2016
• Study Start: September 1, 2016
• Primary Completion: September 1, 2019
• Study Completion: September 1, 2019
• Last Updated: July 10, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)