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

Study Overview
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Brief Summary
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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.

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

Conditions
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Endometritis

Intervention / Treatment
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* Drug: Methergine


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Methergine<br>Methergine group received Methergine 0.2mg po every 6 hours for two days, plus routine postpartum care. | Drug: Methergine<br>* Scheduled methergine 0.2 mg PO every 6hrs for duration of postpartum stay<br>|
| No Intervention: No treatment<br>No treatment group received only routine postpartum care. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endometritis Incidence | Number of participants who developed endometritis | One year |