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

NCT00858832 | Completed Results

• 1 other identifier: 106202
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Endometritis

Outcome Measures

Primary Outcomes (1)

• Endometritis Incidence

  Number of participants who developed endometritis

  One year

Study Arms (2)

Methergine

EXPERIMENTAL

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

Drug: Methergine

No treatment

NO INTERVENTION

No treatment group received only routine postpartum care.

Interventions

Methergine DRUG

Scheduled methergine 0.2 mg PO every 6hrs for duration of postpartum stay

Methergine

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Female singleton gravidas
• Patients receiving non-elective cesarean deliveries after trial of labor
• No evidence of chorioamnionitis

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of South Florida: lead

Study Sites (1)

Tampa General Hospital

Tampa, Florida, 33602, United States

Location

MeSH Terms

Conditions

Endometritis

Interventions

Methylergonovine

Condition Hierarchy (Ancestors)

Pelvic Inflammatory Disease; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Uterine Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Ergonovine; Ergolines; Ergot Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring

Limitations and Caveats

Early termination due to lack of feasibility in completing project; full analysis was not conducted;

Results Point of Contact

• Title: Patrick Teefey MD
• Organization: USF Health Department of Obstetrics and Gynecology

ObGynClinicalResearch@health.usf.edu

813-259-8680

Study Officials

• Patrick Teefey, MD

  Univeristy of South Florida OB/GYN

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2009
• First Posted: March 10, 2009
• Study Start: December 1, 2008
• Primary Completion: January 1, 2011
• Study Completion: January 1, 2011
• Last Updated: September 19, 2012
• Results First Posted: September 19, 2012

Record last verified: 2012-09

Locations

US (1)