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

Endometritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00858832
• Other study ID #: 106202
• Status: Completed
• Phase: N/A
• First received: March 9, 2009
• Last updated: September 17, 2012
• Start date: December 2008
• Est. completion date: January 2011

Study information

• Verified date: September 2012
• Source: University of South Florida
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Endometritis

Intervention

Drug:
• Methergine
Scheduled methergine 0.2 mg PO every 6hrs for duration of postpartum stay

Locations

Country	Name	City	State
United States	Tampa General Hospital	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of South Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Endometritis Incidence	Number of participants who developed endometritis	One year	No