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OpenTrials
Completed

NCT Number: NCT00858832

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

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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Key information

Conditions

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

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Tampa General Hospital

Tampa, Florida, 33602, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Methergine

Drug

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

Primary outcomes

  1. Endometritis Incidence

    Time frame: One year

    Number of participants who developed endometritis

Sponsors and collaborators

Lead sponsor

University of South Florida

Other

Registry information

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Mar 10, 2009
Registry last updated
Sep 19, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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