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

University of South Florida

Status: Completed

Conditions: Endometritis

Treatments: Drug: Methergine

Study type: Interventional

Funder types: Other

Identifiers

NCT00858832

106202

Details and patient eligibility

About

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.

Enrollment: 44 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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44 participants in 2 patient groups

Methergine

Experimental group

Description:

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

Treatment:

Drug: Methergine

No treatment

No Intervention group

Description:

No treatment group received only routine postpartum care.