Endometritis
Conditions
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.
Interventions
DRUGMethergine
Scheduled methergine 0.2 mg PO every 6hrs for duration of postpartum stay
Sponsors
University of South Florida
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Endometritis Incidence | One year | Number of participants who developed endometritis |
Countries
United States
Participant flow
Recruitment details
Recruitment began 01dec2008 and was terminated 30apr2010. All recruitment was in a hospital.
Pre-assignment details
There were no washouts or run-ins. Patients were eligible upon the decision for a Cesarean delivery and then consented and randomized.
Participants by arm
| Arm | Count |
|---|---|
| Methergine | 21 |
| No Methergine | 23 |
| Total | 44 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 |
| Overall Study | became ineligible: delivered vaginally | 1 | 0 |
Baseline characteristics
| Characteristic | Methergine | No Methergine | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 21 Participants | 23 Participants | 44 Participants |
| Sex: Female, Male Female | 21 Participants | 23 Participants | 44 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 21 | 1 / 23 |
| serious Total, serious adverse events | 0 / 21 | 0 / 23 |
Outcome results
Primary
Endometritis Incidence
Number of participants who developed endometritis
Time frame: One year
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Methergine | Endometritis Incidence | 0 participants |
| No Methergine | Endometritis Incidence | 0 participants |