Reduction of Endometritis After Cesarean Section With the Routine Use of Methergine
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Endometritis |
Drug: Methergine |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Reduction of Endometritis After Cesarean Section With the Routine Use of Methergine |
- Endometritis Incidence [ Time Frame: One year ] [ Designated as safety issue: No ]Number of participants who developed endometritis
| Enrollment: | 44 |
| Study Start Date: | December 2008 |
| Study Completion Date: | January 2011 |
| Primary Completion Date: | January 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Methergine
Methergine group received Methergine 0.2mg po every 6 hours for two days, plus routine postpartum care.
|
Drug: Methergine
Scheduled methergine 0.2 mg PO every 6hrs for duration of postpartum stay
|
|
No Intervention: No treatment
No treatment group received only routine postpartum care.
|
Eligibility| Ages Eligible for Study: | 18 Years to 45 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
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.
Contacts and Locations| United States, Florida | |
| Tampa General Hospital | |
| Tampa, Florida, United States, 33602 | |
| Principal Investigator: | Patrick Teefey, MD | Univeristy of South Florida OB/GYN |
More Information
No publications provided
| Responsible Party: | University of South Florida |
| ClinicalTrials.gov Identifier: | NCT00858832 History of Changes |
| Other Study ID Numbers: | 106202 |
| Study First Received: | March 9, 2009 |
| Results First Received: | July 5, 2012 |
| Last Updated: | September 17, 2012 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Endometritis Pelvic Inflammatory Disease Adnexal Diseases Genital Diseases, Female Uterine Diseases Methylergonovine |
Oxytocics Reproductive Control Agents Physiological Effects of Drugs Pharmacologic Actions Therapeutic Uses |
ClinicalTrials.gov processed this record on May 19, 2013