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

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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)

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.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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