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Reduction of Endometritis After Cesarean Section With the Routine Use of Methergine

Primary Purpose

Endometritis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Methergine
Sponsored by
University of South Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Endometritis

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  1. Female singleton gravidas
  2. Patients receiving non-elective cesarean deliveries after trial of labor
  3. No evidence of chorioamnionitis

Exclusion Criteria:

  1. Diagnosis of chorioamnionitis
  2. Elective cesarean section
  3. Unable to provide informed consent
  4. Immunocompromised patients and those on antiretroviral drugs
  5. Patients with known infection
  6. Hypertension (blood pressure greater than 140/90 x 2, six hours apart), including those with a past history, gestational or Preeclampsia.
  7. Allergic to ergot alkaloids. This would include people allergic to migraine medicine.

Sites / Locations

  • Tampa General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Methergine

No treatment

Arm Description

Methergine group received Methergine 0.2mg po every 6 hours for two days, plus routine postpartum care.

No treatment group received only routine postpartum care.

Outcomes

Primary Outcome Measures

Endometritis Incidence
Number of participants who developed endometritis

Secondary Outcome Measures

Full Information

First Posted
March 9, 2009
Last Updated
September 17, 2012
Sponsor
University of South Florida
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1. Study Identification

Unique Protocol Identification Number
NCT00858832
Brief Title
Reduction of Endometritis After Cesarean Section With the Routine Use of Methergine
Official Title
Reduction of Endometritis After Cesarean Section With the Routine Use of Methergine
Study Type
Interventional

2. Study Status

Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
January 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of South Florida

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Endomyometritis is an "infection in the uterus". It can occur in up to 1 out of 5 women having unplanned cesarean deliveries. Antibiotics are routinely given at the time of Cesarean delivery, but the infection in the uterus can still occur. When endomyometritis occurs it can prolong the woman's stay in the hospital after birth, slow down her recovery time at home, and increase medical costs. Methergine is a medication that is routinely used to stop uterine hemorrhage (excessive bleeding from the uterus) that sometimes happens after delivery. Methergine works by contracting (tightening) the uterus. These contractions also help the uterus to expel or remove parts of the placenta that increase the chance of developing a uterine infection. This research study is being done to learn if routine use of Methergine can lower the chances of developing a uterine infection after cesarean delivery. Half of the women in this study will receive Methergine for a few days during their hospitalization after cesarean delivery. The other half of the women will not routinely receive Methergine.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometritis

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Methergine
Arm Type
Experimental
Arm Description
Methergine group received Methergine 0.2mg po every 6 hours for two days, plus routine postpartum care.
Arm Title
No treatment
Arm Type
No Intervention
Arm Description
No treatment group received only routine postpartum care.
Intervention Type
Drug
Intervention Name(s)
Methergine
Intervention Description
Scheduled methergine 0.2 mg PO every 6hrs for duration of postpartum stay
Primary Outcome Measure Information:
Title
Endometritis Incidence
Description
Number of participants who developed endometritis
Time Frame
One year

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Female singleton gravidas Patients receiving non-elective cesarean deliveries after trial of labor No evidence of chorioamnionitis Exclusion Criteria: Diagnosis of chorioamnionitis Elective cesarean section Unable to provide informed consent Immunocompromised patients and those on antiretroviral drugs Patients with known infection Hypertension (blood pressure greater than 140/90 x 2, six hours apart), including those with a past history, gestational or Preeclampsia. Allergic to ergot alkaloids. This would include people allergic to migraine medicine.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patrick Teefey, MD
Organizational Affiliation
Univeristy of South Florida OB/GYN
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tampa General Hospital
City
Tampa
State/Province
Florida
ZIP/Postal Code
33602
Country
United States

12. IPD Sharing Statement

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Reduction of Endometritis After Cesarean Section With the Routine Use of Methergine

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