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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rebekah McCurdy, MD | Contact | 215-955-9200 | Rebekah.McCurdy@jefferson.edu | |
| Laura Felder, MD | Contact | 215-955-9200 | Laura.Felder@jefferson.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Thomas Jefferson University Hospital | Recruiting | Philadelphia | Pennsylvania | 19107 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19879392 | Background | 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. | |
| 17716296 | 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. |
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| 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 |
| 25457856 | 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. |
| 10819819 | 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. |
| 14672469 | 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. |
| 20678746 | 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. |
| 24560557 | 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. |
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