N/A N=44 Randomized Prevention

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

Endometritis

Bottom Line

View on ClinicalTrials.gov: NCT00858832 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Sep 2012

Primary outcome: Primary: Endometritis Incidence — 0; 0 participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Methergine (Drug)
Age: Adult · 18+ yrs
Sex: Female
Sponsor: University of South Florida
Primary completion: Jan 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY Endometritis Incidence	0; 0	—

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.

Eligibility Criteria

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.

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Data sourced from ClinicalTrials.gov (NCT00858832). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.