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Intrauterine Cleaning After Placental Delivery at Cesarean Section: RCT

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ClinicalTrials.gov Identifier: NCT02152735
Recruitment Status : Completed
First Posted : June 2, 2014
Last Update Posted : November 25, 2015
Sponsor:
Information provided by (Responsible Party):
Denny Martin, Michigan State University

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.


Condition or disease Intervention/treatment Phase
Pregnancy Procedure: Cleaning the uterine cavity Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 206 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Intrauterine Cleaning After Placental Delivery at Cesarean Section: a Randomized Controlled Trial
Study Start Date : July 2014
Actual Primary Completion Date : July 2015
Actual Study Completion Date : November 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cesarean Section

Arm Intervention/treatment
Active Comparator: Cleaning the uterine cavity
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
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

No Intervention: Not cleaning the uterine cavity
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.



Primary Outcome Measures :
  1. Endomyometritis after delivery [ Time Frame: Within 6 weeks 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.


Secondary Outcome Measures :
  1. Post partum hemorrhage [ Time Frame: Within 6 weeks after delivery ]
  2. Mean surgical time [ Time Frame: Immediately post cesarean ]
  3. Retained products of conception [ Time Frame: Within 6 weeks post delivery ]
  4. Retained placenta [ Time Frame: Within 6 weeks post delivery ]
  5. Quantitative blood loss [ Time Frame: Within 6 weeks post delivery ]
  6. Hospital length of stay [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 4 days postpartum ]
  7. Return of gastrointestinal function [ Time Frame: Participants will be followed for the duration to return of bowel function, an expected average of 2 days postpartum ]
  8. Repeat surgery [ Time Frame: Within 6 weeks post delivery ]
  9. Hospital readmission rates. [ Time Frame: Within 6 weeks post delivery ]


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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02152735


Locations
United States, Michigan
Sparrow Hospital/Michigan State University
Lansing, Michigan, United States, 48912
Sponsors and Collaborators
Michigan State University
Investigators
Principal Investigator: 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
Study Director: Steven Roth, MD, FACOG Dept of Obstetrics and Gynecology, Michigan State University/Sparrow Hospital, Lansing, MI 48912

Publications:
Pelosi MA, II, Pelosi MA, III. Simplified cesarean section. Contemp OB/GYN. 1995; 40:89-100

Responsible Party: Denny Martin, Assistant Professor, Obstetrics and Gynecology, Michigan State University
ClinicalTrials.gov Identifier: NCT02152735     History of Changes
Other Study ID Numbers: MSU IRB# 14-459
First Posted: June 2, 2014    Key Record Dates
Last Update Posted: November 25, 2015
Last Verified: November 2015