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

Not Applicable

Completed

• Conditions: Endometritis
• Interventions: Drug: Methergine

• Registration Number: NCT00858832
• Lead Sponsor: University of South Florida

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-12
• Study First Submitted: 2009-03-09
• Study First Submitted QC: 2009-03-09
• Study First Posted: 2009-03-10
• Primary Completion: 2011-01
• Study Completion: 2011-01
• Results First Submitted: 2012-07-05
• Status Verified: 2012-09
• Results First Submitted QC: 2012-09-17
• Last Update Submitted: 2012-09-17
• Results First Posted: 2012-09-19
• Last Update Posted: 2012-09-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 44

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Endometritis Incidence	One year	Number of participants who developed endometritis

Trial Locations

Locations (1)

Tampa General Hospital; 🇺🇸 Tampa, Florida, United States