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

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ClinicalTrials.gov Identifier: NCT00858832
Recruitment Status : Completed
First Posted : March 10, 2009
Results First Posted : September 19, 2012
Last Update Posted : September 19, 2012
Sponsor:
Information provided by (Responsible Party):
University of South Florida

Study Description
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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.


Condition or disease Intervention/treatment Phase
Endometritis Drug: Methergine Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Reduction of Endometritis After Cesarean Section With the Routine Use of Methergine
Study Start Date : December 2008
Actual Primary Completion Date : January 2011
Actual Study Completion Date : January 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cesarean Section

Arms and Interventions
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Arm Intervention/treatment
Experimental: Methergine
Methergine group received Methergine 0.2mg po every 6 hours for two days, plus routine postpartum care.
 Drug: Methergine
Scheduled methergine 0.2 mg PO every 6hrs for duration of postpartum stay
No Intervention: No treatment
No treatment group received only routine postpartum care.


Outcome Measures
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Primary Outcome Measures :
  1. Endometritis Incidence [ Time Frame: One year ]
    Number of participants who developed endometritis


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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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): NCT00858832


Locations
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United States, Florida
Tampa General Hospital
Tampa, Florida, United States, 33602
Sponsors and Collaborators
University of South Florida
Investigators
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Principal Investigator: Patrick Teefey, MD Univeristy of South Florida OB/GYN
More Information
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Responsible Party: University of South Florida
ClinicalTrials.gov Identifier: NCT00858832    
Other Study ID Numbers: 106202
First Posted: March 10, 2009    Key Record Dates
Results First Posted: September 19, 2012
Last Update Posted: September 19, 2012
Last Verified: September 2012
Additional relevant MeSH terms:
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Endometritis
Pelvic Inflammatory Disease
Adnexal Diseases
Uterine Diseases
 Methylergonovine
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs