Obesity: Cesarean Health by Incision Placement
试验速览
- 阶段
- 不适用
- 入组人数
- 284
- 试验地点
- 2
- 主要终点
- Composite Maternal Morbidity
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 55 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •BMI > or = 35 kg/m2 at time of presentation for delivery
- •Speaks English
排除标准
- •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
结局指标
主要结局
Composite Maternal Morbidity
时间窗: 18 months
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.
次要结局
- Attending surgeon satisfaction (on 1-10 Likert scale) with feasibility of surgery by incision type(18 months)
- 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)
- Estimated blood loss (in milliliters)(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)
- Incidence of low transverse uterine incisions (hysterotomy) with all other types of uterine incisions (vertical, high transverse, etc).(18 months)
- Patient satisfaction (via two questions, Likert scale)(18 months)
- Length in minutes of operative time from time of skin incision to time of delivery of the neonate(18 months)
- Severity of pain (via Likert scale) and amount of pain medications utilized in the first 48 hours post procedure(18 months)
研究者
Rebekah McCurdy
Obstetrician/Maternal Fetal Medicine Fellow
Thomas Jefferson University