Clinical trialNCT02152735CompletedInterventional

Intrauterine Cleaning After Placental Delivery at Cesarean Section: RCT

SponsorMichigan State UniversityEnrollment206Pregnancy

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

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Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

Ahizechukwu C Eke, MD, MPH
Dept of Obstetrics and Gynecology, Michigan State University/Sparrow Hospital, Lansing, MI 48912
Principal Investigator
clinicaltrials.gov ↗
Martin Denny, DO, FACOOG
Dept of Obstetrics and Gynecology, Michigan State University/Sparrow Hospital, Lansing, MI 48912
Principal Investigator
clinicaltrials.gov ↗
Steven Roth, MD, FACOG
Dept of Obstetrics and Gynecology, Michigan State University/Sparrow Hospital, Lansing, MI 48912
Study Director
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A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

1 registered facility, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

Sparrow Hospital/michigan State University
Lansing, Michigan, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

No drug or biological interventions are in our data for this study. It may test a procedure, device or behavioral intervention, or the intervention list isn't in our current snapshot. See the registry record ↗. Why? →

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 31 Jul 2014
Primary completion: 31 Jul 2015
Completion: 30 Nov 2015
Last update posted: 25 Nov 2015
Registered enrollment: 206
Registry id: NCT02152735

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.