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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Methergine | Experimental | Methergine group received Methergine 0.2mg po every 6 hours for two days, plus routine postpartum care. |
|
| No treatment | No Intervention | No treatment group received only routine postpartum care. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Methergine | Drug | Scheduled methergine 0.2 mg PO every 6hrs for duration of postpartum stay |
|
| Measure | Description | Time Frame |
|---|---|---|
| Endometritis Incidence | Number of participants who developed endometritis | One year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Patrick Teefey, MD | Univeristy of South Florida OB/GYN | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tampa General Hospital | Tampa | Florida | 33602 | United States |
There were no washouts or run-ins. Patients were eligible upon the decision for a Cesarean delivery and then consented and randomized.
Recruitment began 01dec2008 and was terminated 30apr2010. All recruitment was in a hospital.
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| ID | Title | Description |
|---|---|---|
| FG000 | Methergine | Participants received Methergine 0.2mg orally every 6 hours for 2 days |
| FG001 | No Treatment | Participants received no intervention (no treatment). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Methergine | |
| BG001 | No Methergine | |
| BG002 | Total |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Endometritis Incidence | Number of participants who developed endometritis | Posted | Number | participants | One year |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Methergine |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| elevated blood pressure | Pregnancy, puerperium and perinatal conditions | Systematic Assessment | Adverse event was not believed to be related to treatment. |
Early termination due to lack of feasibility in completing project; full analysis was not conducted;
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Patrick Teefey MD | USF Health Department of Obstetrics and Gynecology | 813-259-8680 | ObGynClinicalResearch@health.usf.edu |
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| ID | Term |
|---|---|
| D004716 | Endometritis |
| ID | Term |
|---|---|
| D000292 | Pelvic Inflammatory Disease |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D008755 | Methylergonovine |
| ID | Term |
|---|---|
| D004874 | Ergonovine |
| D004873 | Ergolines |
| D004876 | Ergot Alkaloids |
| D000470 | Alkaloids |
| D006571 |
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Total of all reporting groups
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
| 0 |
| 21 |
| 0 |
| 21 |
| EG001 | No Methergine | 0 | 23 | 1 | 23 |
|
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| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D014591 | Uterine Diseases |
| D000091662 | Genital Diseases |
| Heterocyclic Compounds |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |