Cohen vs Pfannenstiel cesarean skin incision for body mass index ≥35 kg/m2: a randomized controlled trial

IF 3.8 2区 医学 Q1 OBSTETRICS & GYNECOLOGY
Rebekah J. McCurdy MD, MPH, PhD , Siani Harding BA , Laura Felder MD , Anita Beáta DO , Peter Schnatz DO , Vincenzo Berghella MD
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引用次数: 0

Abstract

BACKGROUND

Maternal obesity is recognized as a significant risk factor for adverse pregnancy outcomes, including increased cesarean delivery rates and heightened surgical complications. It is unclear whether the Cohen or Pfannenstiel skin incisions for cesarean delivery are associated with different outcomes.

OBJECTIVE

This study aimed to evaluate the effect of a Cohen or Pfannenstiel cesarean skin incision on maternal morbidity.

STUDY DESIGN

Pregnant individuals with a body mass index of ≥35 kg/m2, carrying either singleton or multiple pregnancies, were consented prenatally and in labor. Eligible participants who underwent a cesarean delivery between 24 and 41 weeks of gestation were randomized to either the Pfannenstiel or Cohen skin incision group at Thomas Jefferson University Hospital from October 2016 to March 2020. This study aimed to recruit 284 participants based on a sample size calculation, assuming a 50% reduction in wound complications with Cohen vs Pfannenstiel incisions (80% power; α=.05). However, recruitment was terminated early after 72 participants were randomized. The primary outcome was a composite maternal morbidity within 6 weeks, which consisted of the following: wound infection, hematoma, seroma, separation of skin of ≥1 cm, readmission for wound complications, endometritis, and postpartum hemorrhage. Statistical analyses included bivariate tests, t tests, and nonparametric analyses.

RESULTS

Of 331 pregnant individuals who consented prenatally and in labor, 72 eventually underwent cesarean delivery and were randomized, 34 to the Cohen skin incision group and 38 to the Pfannenstiel skin incision group. The mean body mass index was >42 kg/m2. Approximately two-thirds of the patients had a pannus, 56% of the patients were Black, 47% of the patients had diabetes mellitus, and 56% of the patients had hypertensive disorders. The primary outcome of composite maternal morbidity occurred in 47.1% of patients in the Cohen incision group and 36.8% of patients in the Pfannenstiel incision group (risk ratio, 1.24; 95% confidence interval, 0.71–2.08) and was similar regardless of the presence of a pannus or degree of obesity. Surgical site infection, hematoma, seroma, wound separation/dehiscence, endometritis, and postpartum hemorrhage were similar between the Cohen and Pfannenstiel groups. In addition, neonatal outcomes were similar between the Cohen and Pfannenstiel groups, except that the Cohen incision group was found to have a statistically significantly lower Apgar score at 5 minutes and a higher need for respiratory support than the Pfannenstiel incision group, possibly related to the trend for a longer time from skin incision to delivery. Physicians were found to be significantly less satisfied with the Cohen incision than the Pfannenstiel incision.

CONCLUSION

In pregnant patients with a body mass index of ≥35 kg/m2, obstetrical providers can choose from either a Cohen or Pfannenstiel skin incision, as they are generally associated with similar outcomes, except for lower Apgar scores and lower physician satisfaction associated with the Cohen incision. Our findings are limited by the trial's early cessation for logistical reasons, leading to an underpowered analysis. It is crucial to acknowledge that the results must be interpreted cautiously because of the reduced sample size. Our data can inform future trial design and implementation and fuel individual patient-level meta-analyses on this topic.
BMI = 35 kg/m2 时的 Cohen 与 Pfannenstiel 剖宫产皮肤切口:随机对照试验。
背景:产妇肥胖被认为是导致不良妊娠结局的重要风险因素,包括剖宫产率增加和手术并发症增加。目前还不清楚在剖宫产时采用 Cohen 或 Pfannenstiel 皮肤切口是否会导致不同的结果:目的:评估 Cohen 或 Pfannenstiel 剖宫产皮肤切口类型对产妇发病率的影响:研究设计:体重指数(BMI)≥35 kg/m2、单胎或多胎妊娠的孕妇在产前和分娩时均同意进行剖宫产。2016年10月至2020年3月期间,托马斯-杰斐逊大学医院对在妊娠24周至41周之间进行剖宫产的合格参与者随机进行了Pfannenstiel或Cohen皮肤切口。该研究的目标是招募 284 名参与者,根据样本量计算,假设 Cohen 切口与 Pfannenstiel 切口相比,伤口并发症减少 50%(80% 功率,α=0.05),但招募工作在 72 名参与者被随机分配后提前终止。主要结果是六周内产妇的综合发病率,包括:伤口感染、血肿、血清肿、皮肤分离≥1厘米、因伤口并发症再次入院、子宫内膜炎和产后出血。统计分析包括双变量检验、t 检验和非参数分析:在331名经产前和分娩同意的孕妇中,有72人最终接受了剖宫产手术,其中34人被随机分配到Cohen切口,38人被随机分配到Pfannenstiel切口。平均体重指数(BMI)大于 42 kg/m2,约三分之二的患者有脓肿,56% 为黑人,47% 患有糖尿病,56% 患有高血压。科恩组和普凡诺斯蒂尔组的产妇综合发病率的主要结果分别为 47.1%和 36.8%(RR 1.24,95% CI 0.71-2.08),而且无论是否存在脓肿或肥胖程度如何,产妇综合发病率的主要结果都相似。科恩组和普范尼斯提尔组的手术部位感染、血肿、血清肿、伤口分离/开裂、子宫内膜炎和产后出血的发生率相似。科恩组和普凡诺斯蒂尔组的新生儿结果也相似,但科恩组在 5 分钟内的 Apgar 评分明显低于普凡诺斯蒂尔组,需要呼吸支持的人数也高于普凡诺斯蒂尔组,这可能与从皮肤切口到分娩的时间较长有关。医生对 Cohen 切口的满意度明显低于 Pfannenstiel 切口:结论:对于体重指数(BMI)≥35 kg/m2的孕妇,产科医生可以选择科恩切口或普芬南斯蒂尔切口,因为除了科恩切口的Apgar评分较低和医生满意度较低外,两者的结果基本相似。由于后勤原因,这项研究提前结束,导致分析结果效力不足,从而使研究结果受到限制。必须承认的是,由于样本量减少以及研究终止的原因,必须谨慎解释这些结果。这些数据可以为未来的试验设计和实施提供参考,并为有关该主题的个体患者层面的荟萃分析提供帮助。
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来源期刊
CiteScore
7.40
自引率
3.20%
发文量
254
审稿时长
40 days
期刊介绍: The American Journal of Obstetrics and Gynecology (AJOG) is a highly esteemed publication with two companion titles. One of these is the American Journal of Obstetrics and Gynecology Maternal-Fetal Medicine (AJOG MFM), which is dedicated to the latest research in the field of maternal-fetal medicine, specifically concerning high-risk pregnancies. The journal encompasses a wide range of topics, including: Maternal Complications: It addresses significant studies that have the potential to change clinical practice regarding complications faced by pregnant women. Fetal Complications: The journal covers prenatal diagnosis, ultrasound, and genetic issues related to the fetus, providing insights into the management and care of fetal health. Prenatal Care: It discusses the best practices in prenatal care to ensure the health and well-being of both the mother and the unborn child. Intrapartum Care: It provides guidance on the care provided during the childbirth process, which is critical for the safety of both mother and baby. Postpartum Issues: The journal also tackles issues that arise after childbirth, focusing on the postpartum period and its implications for maternal health. AJOG MFM serves as a reliable forum for peer-reviewed research, with a preference for randomized trials and meta-analyses. The goal is to equip researchers and clinicians with the most current information and evidence-based strategies to effectively manage high-risk pregnancies and to provide the best possible care for mothers and their unborn children.
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