Intrauterine Cleaning After Placental Delivery at Cesarean Section: RCT

NCT02152735 | Completed DMC

• 1 other identifier: MSU IRB# 14-459
• Study Type: interventional
• Target: 206
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Endomyometritis after delivery

  Endomyometritis will be diagnosed by the presence of two or more of the following: abnormally tender uterus on examination, temperature more than 38.0°C at any time postoperatively, and unexplained maternal tachycardia more than 100 beats per minute (bpm). A diagnosis of endomyometritis will be criteria for initiating treatment with antibiotics.

  Within 6 weeks after delivery

Secondary Outcomes (9)

• Post partum hemorrhage

  Within 6 weeks after delivery

• Mean surgical time

  Immediately post cesarean

• Retained products of conception

  Within 6 weeks post delivery

• Retained placenta

  Within 6 weeks post delivery

• Quantitative blood loss

  Within 6 weeks post delivery

Study Arms (2)

Cleaning the uterine cavity

ACTIVE COMPARATOR

Cleaning the uterine cavity: 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.

Procedure: Cleaning the uterine cavity

Not cleaning the uterine cavity

NO INTERVENTION

These participants will have their uterine cavities left alone after complete delivery of the placenta. The placenta will be inspected after delivery to make sure it is complete, including the membranes.

Interventions

Cleaning the uterine cavity PROCEDURE

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

Cleaning the uterine cavity

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Women with singleton or multiple pregnancies, vertex or breech presentation with intact membranes presenting to our labor and delivery unit for cesarean section will be evaluated for participation

You may not qualify if:

• 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.

Sponsors & Collaborators

• Michigan State University: lead

Study Sites (1)

Sparrow Hospital/Michigan State University

Lansing, Michigan, 48912, United States

Location

Related Publications (24)

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  BACKGROUND

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Study Officials

• Ahizechukwu C Eke, MD, MPH

  Dept of Obstetrics and Gynecology, Michigan State University/Sparrow Hospital, Lansing, MI 48912

  PRINCIPAL INVESTIGATOR

• Martin Denny, DO, FACOOG

  Dept of Obstetrics and Gynecology, Michigan State University/Sparrow Hospital, Lansing, MI 48912

  PRINCIPAL INVESTIGATOR

• Steven Roth, MD, FACOG

  Dept of Obstetrics and Gynecology, Michigan State University/Sparrow Hospital, Lansing, MI 48912

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Obstetrics and Gynecology

Study Record Dates

• First Submitted: May 22, 2014
• First Posted: June 2, 2014
• Study Start: July 1, 2014
• Primary Completion: July 1, 2015
• Study Completion: November 1, 2015
• Last Updated: November 25, 2015

Record last verified: 2015-11

Locations

US (1)