Clinical trial NCT02909582: Obesity: Cesarean Health by Incision Placement
Official title: Obesity: Cesarean Health by Incision Placement
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Maternal Morbidity
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
First posted: 2016-09-21
Enrollment: 284
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Composite Maternal Morbidity
timeFrame: 18 months
Secondary outcomes:
measure: Composite maternal morbidity (as above) by stage of pannus
timeFrame: 18 months
measure: Composite wound complication rates (cellulitis, wound abscess, wound separation or dehiscence, hematoma, seroma)
timeFrame: 18 months
measure: Length in minutes of operative time from time of skin incision to time of delivery of the neonate
timeFrame: 18 months
measure: Length in minutes of total operating time (from time of skin incision to the completion of closure of the skin incision)
timeFrame: 18 months
measure: Patient satisfaction (via two questions, Likert scale)
timeFrame: 18 months
measure: Severity of pain (via Likert scale) and amount of pain medications utilized in the first 48 hours post procedure
timeFrame: 18 months
measure: Estimated blood loss (in milliliters)
timeFrame: 18 months
measure: Incidence of low transverse uterine incisions (hysterotomy) with all other types of uterine incisions (vertical, high transverse, etc).
timeFrame: 18 months
measure: Attending surgeon satisfaction (on 1-10 Likert scale) with feasibility of surgery by incision type
timeFrame: 18 months
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Thomas Jefferson University Hospital
state: Pennsylvania
Study officials:
References:
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.
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.
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.
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.
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.
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.
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.