Obesity: Cesarean Health by Incision Placement
Keywords
Abstract
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.
Dates
| Last Verified: | 06/30/2018 |
| First Submitted: | 09/15/2016 |
| Estimated Enrollment Submitted: | 09/15/2016 |
| First Posted: | 09/20/2016 |
| Last Update Submitted: | 07/08/2018 |
| Last Update Posted: | 07/09/2018 |
| Actual Study Start Date: | 08/31/2016 |
| Estimated Primary Completion Date: | 08/31/2019 |
| Estimated Study Completion Date: | 08/31/2019 |
Condition or disease
Intervention/treatment
Procedure: Cohen Incision
Phase
Arm Groups
| Arm | Intervention/treatment |
|---|---|
| No Intervention: Pfannenstiel Incision 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. | |
| Experimental: 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. | 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. |
Eligibility Criteria
| Ages Eligible for Study | 16 Years To 16 Years |
| Sexes Eligible for Study | Female |
| Accepts Healthy Volunteers | Yes |
| 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 |
Outcome
Primary Outcome Measures
1. Composite Maternal Morbidity [18 months]
Secondary Outcome Measures
1. Composite maternal morbidity (as above) by stage of pannus [18 months]
2. Composite wound complication rates (cellulitis, wound abscess, wound separation or dehiscence, hematoma, seroma) [18 months]
3. Length in minutes of operative time from time of skin incision to time of delivery of the neonate [18 months]
4. Length in minutes of total operating time (from time of skin incision to the completion of closure of the skin incision) [18 months]
5. Patient satisfaction (via two questions, Likert scale) [18 months]
6. Severity of pain (via Likert scale) and amount of pain medications utilized in the first 48 hours post procedure [18 months]
7. Estimated blood loss (in milliliters) [18 months]
8. Incidence of low transverse uterine incisions (hysterotomy) with all other types of uterine incisions (vertical, high transverse, etc). [18 months]
9. Attending surgeon satisfaction (on 1-10 Likert scale) with feasibility of surgery by incision type [18 months]
