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Intrauterine Cleaning After Placental Delivery at Cesarean Section: RCT

NCT02152735 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 206

Last updated 2015-11-25

No results posted yet for this study

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.

Conditions

  • Pregnancy

Interventions

PROCEDURE

Cleaning the uterine cavity

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

Sponsors & Collaborators

Principal Investigators

  • Ahizechukwu C Eke, MD, MPH · Dept of Obstetrics and Gynecology, Michigan State University/Sparrow Hospital, Lansing, MI 48912

  • Martin Denny, DO, FACOOG · Dept of Obstetrics and Gynecology, Michigan State University/Sparrow Hospital, Lansing, MI 48912

  • Steven Roth, MD, FACOG · Dept of Obstetrics and Gynecology, Michigan State University/Sparrow Hospital, Lansing, MI 48912

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-07-31
Primary Completion
2015-07-31
Completion
2015-11-30

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02152735 on ClinicalTrials.gov