Pfannenstiel versus Vertical Skin Incision for Cesarean Delivery in Women with Class III Obesity: A Randomized Trial

Caroline Marrs; Sean Blackwell; Ashley Hester; Gayle Olson; George R. Saade; Jonathan Faro; Claudia Pedroza; Baha Sibai

doi:10.1055/s-0038-1667287

American Journal of Perinatology, Inhaltsverzeichnis

Am J Perinatol 2019; 36(01): 097-104
DOI: 10.1055/s-0038-1667287

SMFM Fellowship Series Article

Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.

Pfannenstiel versus Vertical Skin Incision for Cesarean Delivery in Women with Class III Obesity: A Randomized Trial

Caroline Marrs

¹Division of Maternal Fetal Medicine, The University of Texas Medical Branch, Galveston, Texas

,

Sean Blackwell

²Department of Obstetrics and Gynecology, McGovern Medical School, University of Texas Health Science Center at Houston, Houston, Texas

,

Ashley Hester

²Department of Obstetrics and Gynecology, McGovern Medical School, University of Texas Health Science Center at Houston, Houston, Texas

,

Gayle Olson

¹Division of Maternal Fetal Medicine, The University of Texas Medical Branch, Galveston, Texas

,

George R. Saade

¹Division of Maternal Fetal Medicine, The University of Texas Medical Branch, Galveston, Texas

,

Jonathan Faro

²Department of Obstetrics and Gynecology, McGovern Medical School, University of Texas Health Science Center at Houston, Houston, Texas

,

Claudia Pedroza

³Center for Clinical Research and Evidence-Based Medicine, McGovern Medical School, University of Texas Health Science Center at Houston, Houston, Texas

,

Baha Sibai

²Department of Obstetrics and Gynecology, McGovern Medical School, University of Texas Health Science Center at Houston, Houston, Texas

› Institutsangaben

Abstract

Objective To compare Pfannenstiel versus vertical skin incision for the prevention of cesarean wound complications in morbidly obese women.

Study Design Women with body mass index ≥ 40 kg/m² undergoing cesarean delivery (CD) were randomly allocated to Pfannenstiel or vertical skin incision. The primary outcome was a wound complication within 6 weeks. Due to a low consent rate, we limited enrollment to a defined time period for feasibility. We conducted a traditional frequentist analysis with log-binomial regression to obtain relative risks (RRs), and a Bayesian analysis to estimate the probability of treatment benefit. A priori, we decided that a ≥60% probability of treatment benefit for either incision type would be convincing evidence to pursue a larger trial.

Results A total of 648 women were approached, 228 were consented, and 91 were randomized. The primary outcome rate was 19% in the Pfannenstiel group and 21% in the vertical group (RR: 1.18; 95% confidence interval: 0.49–2.85). Bayesian analysis revealed a 59% probability that Pfannenstiel had a lower primary outcome rate.

Conclusion In the first published randomized trial to compare skin incision types for obese women undergoing CD, we were unable to demonstrate differences in clinical outcomes. Our trial suggests that a larger study would have a low probability for different findings.

Trial Registration NCT 01897376 (www.clinicaltrials.gov).

Keywords

cesarean - skin incision - Pfannenstiel - transverse - vertical - wound infection - complication - obesity

Volltext

Referenzen

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