At a glance
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Intrauterine Cleaning After Placental Delivery at Cesarean Section: a Randomized Controlled Trial
In Brief
A clinical study evaluating Cleaning the uterine cavity for Pregnancy. Completed, enrolled 206 participants across 1 site.
Detailed Summary
PURPOSE: To test the hypothesis that omission of intrauterine cleaning during cesarean deliveries does not increase intraoperative and postoperative complications. METHODS: We plan to randomize 206 women undergoing primary and repeat cesarean deliveries to cleaning (n=103) versus no cleaning (n=103) of the uterine cavity following placental delivery. Women will be excluded if any of the following criteria are encountered: preterm premature rupture of membranes, spontaneous rupture of membranes prior to cesarean section, chorioamnionitis, fetal demise, uncontrolled diabetes or an immunosuppressive disorder. Primary outcome measure will be endo-myometritis after delivery. Secondary outcomes will include post partum hemorrhage, mean surgical time, retained products of conception, retained placenta, quantitative blood loss, length of hospital stay, return of gastrointestinal function, repeat surgery, and hospital readmission rates. Analysis will follow the intention-to-treat principle. GENERAL DESIGN All eligible patients who are scheduled for cesarean section at the Sparrow hospital/Michigan State University Resident OBGYN and Perinatology clinics will be evaluated for study inclusion. Patients meeting this study's inclusion criteria and lack exclusion criteria will be approached for consent and enrollment.
Study Details
Timeline
Interventions
These participants will have their uterine cavities cleaned with a dry laparotomy sponge after delivery of the placenta. Per standard protocol, the uterus will be explored with one hand holding a sponge to remove any remaining membranes or placental tissue, while the other hand is placed on the fundus to stabilize the uterus