Ahizechukwu C Eke1, Sheila Drnec2, Andrea Buras2, Joanna Woo2, Denny Martin2, Steven Roth3. 1. a Division of Maternal Fetal Medicine, Department of Gynecology and Obstetrics , Johns Hopkins University School of Medicine , Baltimore , MD , USA. 2. b Division of General Obstetrics & Gynecology , Michigan State University Women's Health Center , Lansing , MI , USA. 3. c Division of Maternal Fetal Medicine, Department of Obstetrics and Gynecology , Michigan State University/Sparrow Hospital , Lansing , MI , USA.
Abstract
OBJECTIVE: The objective of this study is to evaluate whether omission of intrauterine cleaning increases intraoperative and postoperative complications among women who deliver via cesarean section. METHODS: We randomized 206 women undergoing primary elective cesarean deliveries to intrauterine cleaning or omission of cleaning. Postpartum endomyometritis rates across groups were the primary outcome. We also examined secondary outcomes. To detect a 20% difference in infection rate between the cleaned and the non-cleaned groups (two-tailed [alpha] = 0.05, [beta] = 0.2), 103 women were required per group. Analysis was by intention-to-treat. RESULTS:Two hundred and six were randomized as follows: 103 tointrauterine cleaning and 103 to omission of cleaning after placental delivery. There were no statistically significant differences in the rate of endomyometritis between the two groups (2.0% versus 2.9%, RR =0.60; 95% CI 0.40-1.32). There were no statistically significant differences in postpartum hemorrhage rates (5.8% versus 7.7%, RR 0.75; 95% CI 0.6-1.2), hospital readmission rates (2.9 versus 3.8%, RR 0.75; 95% CI 0.5-1.6), time to return of gastrointestinal function, need for repeat surgery, or quantitated blood loss between the two groups. CONCLUSIONS: Our randomized controlled trial provides evidence suggesting that omission of intrauterine cleaning during cesarean deliveries in women at low risk of infection does not increase intraoperative or postoperative complications.
RCT Entities:
OBJECTIVE: The objective of this study is to evaluate whether omission of intrauterine cleaning increases intraoperative and postoperative complications among women who deliver via cesarean section. METHODS: We randomized 206 women undergoing primary elective cesarean deliveries to intrauterine cleaning or omission of cleaning. Postpartum endomyometritis rates across groups were the primary outcome. We also examined secondary outcomes. To detect a 20% difference in infection rate between the cleaned and the non-cleaned groups (two-tailed [alpha] = 0.05, [beta] = 0.2), 103 women were required per group. Analysis was by intention-to-treat. RESULTS: Two hundred and six were randomized as follows: 103 to intrauterine cleaning and 103 to omission of cleaning after placental delivery. There were no statistically significant differences in the rate of endomyometritis between the two groups (2.0% versus 2.9%, RR =0.60; 95% CI 0.40-1.32). There were no statistically significant differences in postpartum hemorrhage rates (5.8% versus 7.7%, RR 0.75; 95% CI 0.6-1.2), hospital readmission rates (2.9 versus 3.8%, RR 0.75; 95% CI 0.5-1.6), time to return of gastrointestinal function, need for repeat surgery, or quantitated blood loss between the two groups. CONCLUSIONS: Our randomized controlled trial provides evidence suggesting that omission of intrauterine cleaning during cesarean deliveries in women at low risk of infection does not increase intraoperative or postoperative complications.
Authors: M Whitby; M-L McLaws; B Collopy; D F L Looke; S Doidge; B Henderson; L Selvey; G Gardner; J Stackelroth; A Sartor Journal: J Hosp Infect Date: 2002-11 Impact factor: 3.926