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

NCT ID: NCT00858832

Last Updated: 2012-09-19

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-12-31

Study Completion Date

2011-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Endometritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Methergine

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

Group Type EXPERIMENTAL

Methergine

Intervention Type DRUG

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

No treatment

No treatment group received only routine postpartum care.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Methergine

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of South Florida

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Patrick Teefey, MD

Role: PRINCIPAL_INVESTIGATOR

Univeristy of South Florida OB/GYN

Locations

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Tampa General Hospital

Tampa, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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106202

Identifier Type: -

Identifier Source: org_study_id