HemorrhagePhase 4UPTNCT02408965
Uterotonic Prophylaxis Trial
A Phase 4 study testing Methergine in people with Hemorrhage, run by University of California, San Francisco at 1 site in United States.
Trial summary
Excessive bleeding after dilation and evacuation (D\&E) requiring interventions is common, occurring in approximately 30% of cases at one large abortion-providing clinic. Uterotonic prophylaxis at the time of D\&E, particularly with methylergonovine maleate (MM), is a common practice among D\&E providers despite… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hemorrhage
- What is being tested?
- Methergine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 284 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2015to Mar 2017
- Phase
- Phase 4
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Between 20 wks 0 days gestation and 24 wks 0 days gestation
- English or Spanish speaking
- BP before injection 140/90 or below
- 18 years old or over
Who cannot join
- hypertension either on the preoperative or operative day (defined as systolic blood pressure greater than 140 mmHg or diastolic blood pressure greater than 90 mmHg)
- D\&E procedures with more than one day of cervical preparation with dilators
- use of protease inhibitors
- known coagulopathy
- known morbidly adherent placenta
Trial locations and contacts
1 site in 1 country.
United States1 site
SFGH Women's Options Center
San Francisco, California, 94110
About this study
Official title: A Randomized Controlled Trial of Methylergonovine Prophylaxis After Dilation and Evacuation Abortion
Excessive bleeding after dilation and evacuation (D\&E) requiring interventions is common, occurring in approximately 30% of cases at one large abortion-providing clinic. Uterotonic prophylaxis at the time of D\&E, particularly with methylergonovine maleate (MM), is a common practice among D\&E providers despite nearly no evidence for its efficacy. Finding ways to decrease excessive bleeding after D\&E has the potential both to improve patient safety and to reduce costs of provider-initiated interventions. The investigators propose a randomized, controlled trial to investigate the efficacy of MM prophylaxis versus placebo in decreasing excessive bleeding measured by a composite outcome among women undergoing D\&E at 20 to 24 weeks.
- Conditions
- Hemorrhage
- Being tested
- Methergine, placebo
- Medical subject headings
- Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MethergineDrug
Also called methylergonovine maleate
0.2 mg of methylergonovine maleate
placeboOther
saline placebo to maintain blinding
| Study group | Role | What they receive |
|---|---|---|
| methergine | Experimental | Methergine group 0.2 mg of methylergonovine maleate single injection when manual cervical dilation begins the day before the procedure Receives: Drug: Methergine |
| saline placebo | Placebo comparator | Placebo group saline single injection when manual cervical dilation begins the day before the procedure Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Excessive Bleeding as Determined by the Composite Outcome Criteria
Clinical factors included in composite outcome of excessive bleeding after D\&E:
Post-procedure total blood loss > 125cc (after D\&E) Transfusion Admission for bleeding Re-aspiration for bleeding Balloon tamponade Uterine artery embolization Major surgery for bleeding At least 1 uterotonic medication given Prescription given for any uterotonic medication at discharge Uterine compression (uterine massage or manual pressure for 2 minutes
Measured: Approximately 1-2 hours after procedure
Amount of Post-procedure Blood Loss Measured in mL
post-procedure blood loss measured in recovery room
Measured: measured 1 to 2 hours after procedure
Number of Participants Who Had a Balloon Tamponade Placed From Start of Procedure to Hospital Discharge
number of participants who had a balloon tamponade placed
Measured: duration of procedure and until discharged from hospital
Number of Participants Who Returned to OR for Re-aspiration During Recovery Period
Returned to OR for re-aspiration
Measured: from cervical preparation through discharge
Number of Participants Who Were Admitted for Bleeding After Procedure
hospital admission for bleeding post-procedure
Measured: post-procedure and during recovery until discharge
Number of Participants Given Any Uterotonic
any uterotonic medication given intraoperative or postoperative
Measured: intra-operative or post-operative until discharge
Secondary outcomes (3)
Number of Participants Who Reported Nausea up to One Hour After Procedure
Patients' completed survey regarding side effects in recovery room.
Measured: Assessed approximately 1 hour after procedure
Number of Patients Who Reported Vomiting up to One Hour After Procedure
Patients' completed survey regarding side effects in recovery room.
Measured: Assessed approximately 1 hour after procedure
Number of Participants Who Reported Cramping up to One Hour After Procedure
Patients' completed survey regarding side effects in recovery room.
Measured: Assessed approximately 1 hour after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2015 (estimated)
- Study startMar 2015
- Primary completionMar 2017
- Study completionMar 2017
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 HemorrhageStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 284 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jennifer Kerns, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02408965
- Sponsor's protocol ID
- UP Trial 2015
- Acronym
- UPT
- Status last verified
- Aug 2019
- First submitted
- 11 Mar 2015
- Last updated
- 6 Sep 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Methylergonovine Prophylaxis After Dilation and Evacuation Abortion
- ClinicalTrials.gov ID
- NCT02408965
- Acronym / sponsor ID
- UPT / UP Trial 2015
- Conditions
- Hemorrhage
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 284 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- Mar 2015 (actual)
- Primary completion
- Mar 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 6 Apr 2015 (estimated)
- Results
- Posted 6 Sep 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Excessive bleeding after dilation and evacuation (D\&E) requiring interventions is common, occurring in approximately 30% of cases at one large abortion-providing clinic. Uterotonic prophylaxis at the time of D\&E, particularly with methylergonovine maleate (MM), is a common practice among D\&E providers despite nearly no evidence for its efficacy. Finding ways to decrease excessive bleeding after D\&E has the potential both to improve patient safety and to reduce costs of provider-initiated interventions. The investigators propose a randomized, controlled trial to investigate the efficacy of MM prophylaxis versus placebo in decreasing excessive bleeding measured by a composite outcome among women undergoing D\&E at 20 to 24 weeks.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| methergine | Experimental | Drug: MethergineMethergine group 0.2 mg of methylergonovine maleate single injection when manual cervical dilation begins the day before the procedure |
| saline placebo | Placebo comparator | Other: placeboPlacebo group saline single injection when manual cervical dilation begins the day before the procedure |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Between 20 wks 0 days gestation and 24 wks 0 days gestation
- English or Spanish speaking
- BP before injection 140/90 or below
- 18 years old or over
Key exclusion criteria (5 listed)
- hypertension either on the preoperative or operative day (defined as systolic blood pressure greater than 140 mmHg or diastolic blood pressure greater than 90 mmHg)
- D\&E procedures with more than one day of cervical preparation with dilators
- use of protease inhibitors
- known coagulopathy
- known morbidly adherent placenta
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 |
|---|---|---|
| MethergineAlso: methylergonovine maleate0.2 mg of methylergonovine maleate | Drug | methergine |
| placebosaline placebo to maintain blinding | Other | saline placebo |
Primary outcome
Number of Participants With Excessive Bleeding as Determined by the Composite Outcome Criteria
Time frame: Approximately 1-2 hours after procedure
Clinical factors included in composite outcome of excessive bleeding after D\&E: Post-procedure total blood loss > 125cc (after D\&E) Transfusion Admission for bleeding Re-aspiration for bleeding Balloon tamponade Uterine artery embolization Major surgery for bleeding At least 1 uterotonic medication given Prescription given for any uterotonic medication at discharge Uterine compression (uterine massage or manual pressure for 2 minutes
Amount of Post-procedure Blood Loss Measured in mL
Time frame: measured 1 to 2 hours after procedure
post-procedure blood loss measured in recovery room
Number of Participants Who Had a Balloon Tamponade Placed From Start of Procedure to Hospital Discharge
Time frame: duration of procedure and until discharged from hospital
number of participants who had a balloon tamponade placed
Number of Participants Who Returned to OR for Re-aspiration During Recovery Period
Time frame: from cervical preparation through discharge
Returned to OR for re-aspiration
Number of Participants Who Were Admitted for Bleeding After Procedure
Time frame: post-procedure and during recovery until discharge
hospital admission for bleeding post-procedure
Number of Participants Given Any Uterotonic
Time frame: intra-operative or post-operative until discharge
any uterotonic medication given intraoperative or postoperative
3 secondary outcomes
Number of Participants Who Reported Nausea up to One Hour After Procedure
Time frame: Assessed approximately 1 hour after procedure
Number of Patients Who Reported Vomiting up to One Hour After Procedure
Time frame: Assessed approximately 1 hour after procedure
Number of Participants Who Reported Cramping up to One Hour After Procedure
Time frame: Assessed approximately 1 hour after procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Jennifer Kerns, MD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Methergine in people with Hemorrhage, run by University of California, San Francisco 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 4 inclusion and 5 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 6 Sep 2019. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Sep 2019). 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?
Number of Participants With Excessive Bleeding as Determined by the Composite Outcome Criteria (time frame: Approximately 1-2 hours after procedure). The study lists 6 primary outcomes in all. 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 6 Sep 2019.