EndometritisNCT00858832
Reduction of Endometritis After Cesarean Section With the Routine Use of Methergine
A study testing Methergine in people with Endometritis, run by University of South Florida at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Endometritis
- What is being tested?
- Methergine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2008to Jan 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female singleton gravidas
- Patients receiving non-elective cesarean deliveries after trial of labor
- No evidence of chorioamnionitis
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Endometritis
- Being tested
- Methergine
- Medical subject headings
- Endometritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MethergineDrug
Scheduled methergine 0.2 mg PO every 6hrs for duration of postpartum stay
| Study group | Role | What they receive |
|---|---|---|
| Methergine | Experimental | Methergine group received Methergine 0.2mg po every 6 hours for two days, plus routine postpartum care. Receives: Drug: Methergine |
| No treatment | No intervention | No treatment group received only routine postpartum care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endometritis Incidence
Number of participants who developed endometritis
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2009 (estimated)
- Study startDec 2008
- Primary completionJan 2011
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for EndometritisStudies of the same condition, open and under way.
- More trials run by University of South FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Patrick Teefey, MD, Principal investigator, Univeristy of South Florida OB/GYN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00858832
- Sponsor's protocol ID
- 106202
- Status last verified
- Sep 2012
- First submitted
- 9 Mar 2009
- Last updated
- 19 Sep 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reduction of Endometritis After Cesarean Section With the Routine Use of Methergine
- ClinicalTrials.gov ID
- NCT00858832
- Acronym / sponsor ID
- 106202
- Conditions
- Endometritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- University of South FloridaUniversity, hospital or other
- Study start
- Dec 2008
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 10 Mar 2009 (estimated)
- Results
- Posted 19 Sep 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Methergine | Experimental | Drug: MethergineMethergine 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Female singleton gravidas
- Patients receiving non-elective cesarean deliveries after trial of labor
- No evidence of chorioamnionitis
Key exclusion criteria (7 listed)
- Diagnosis of chorioamnionitis
- Elective cesarean section
- Unable to provide informed consent
- Immunocompromised patients and those on antiretroviral drugs
- Patients with known infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MethergineScheduled methergine 0.2 mg PO every 6hrs for duration of postpartum stay | Drug | Methergine |
Primary outcome
Endometritis Incidence
Time frame: One year
Number of participants who developed endometritis
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Endometritis
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Cyclobenzaprine for Postoperative Pain in Minimally Invasive Hysterectomy
Minimally Invasive Surgical Procedures, Abnormal Uterine Bleeding, Unspecified
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GnRH Agonist Pretreatment in Persistent Chronic Endometritis Undergoing FET
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patrick Teefey, MD principal investigator
Univeristy of South Florida OB/GYN
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Methergine in people with Endometritis, run by University of South Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Sep 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Endometritis Incidence (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2012.