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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| methergine | Experimental | Methergine group 0.2 mg of methylergonovine maleate single injection when manual cervical dilation begins the day before the procedure |
|
| saline placebo | Placebo Comparator | Placebo group saline single injection when manual cervical dilation begins the day before the procedure |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Methergine | Drug | 0.2 mg of methylergonovine maleate |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Approximately 1-2 hours after procedure |
| Amount of Post-procedure Blood Loss Measured in mL | post-procedure blood loss measured in recovery room | 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 | 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 | from cervical preparation through discharge |
| Number of Participants Who Were Admitted for Bleeding After Procedure | hospital admission for bleeding post-procedure | post-procedure and during recovery until discharge |
| Number of Participants Given Any Uterotonic | any uterotonic medication given intraoperative or postoperative | intra-operative or post-operative until discharge |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Reported Nausea up to One Hour After Procedure | Patients' completed survey regarding side effects in recovery room. | Assessed approximately 1 hour after procedure |
| Number of Patients Who Reported Vomiting up to One Hour After Procedure |
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Inclusion Criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jennifer Kerns, MD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SFGH Women's Options Center | San Francisco | California | 94110 | United States |
Determined ineligible (n=28) Patient withdrew (n=6) Administrative error (n=2)
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| ID | Title | Description |
|---|---|---|
| FG000 | Methergine | Methergine group |
| FG001 | Placebo | Placebo group |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Methergine | Methergine group |
| BG001 | Placebo | Placebo group |
| BG002 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Count of Participants | Participants | Approximately 1-2 hours after procedure |
|
2 years, March 2015 to March 2017
It took from March 2015 to March 2017 to meet the study sample size. Therefore, the timeframe March 2015 through March 2017 is the duration that adverse events were monitored/collected.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Methergine | Methergine group | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| admission to hospital for bleeding | Reproductive system and breast disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Balloon tamponade | Reproductive system and breast disorders | Non-systematic Assessment |
Designed our study using a one-sided hypothesis given our belief that methergine could not cause increased bleeding based on postpartum data.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jennifer Kerns | UCSF | 4152068715 | Jennifer.kerns@ucsf.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 10, 2014 | Aug 14, 2019 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 10, 2014 | Aug 14, 2019 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D008755 | Methylergonovine |
| ID | Term |
|---|---|
| D004874 | Ergonovine |
| D004873 | Ergolines |
| D004876 | Ergot Alkaloids |
| D000470 | Alkaloids |
| D006571 |
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| placebo | Other | saline placebo to maintain blinding |
|
Patients' completed survey regarding side effects in recovery room. |
| 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. | Assessed approximately 1 hour after procedure |
| Total |
Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Body mass index | Median | Inter-Quartile Range | kg/m2 |
|
| Nulliparous | Count of Participants | Participants |
|
| Prior cesarean section | Count of Participants | Participants |
|
| Gestation | Median | Inter-Quartile Range | weeks |
|
| Needed mechanical dilation | Count of Participants | Participants |
|
| Length of procedure | Median | Inter-Quartile Range | minutes |
|
| Procedural measured blood loss | Median | Inter-Quartile Range | mL |
|
| Current or recent cocaine or methamphetamine use | Count of Participants | Participants |
|
| History of bleeding disorder | Count of Participants | Participants |
|
| Preoperative systolic BP | Mean | Standard Deviation | mmHg |
|
| Preoperative diastolic BP | Mean | Standard Deviation | mmHg |
|
|
|
|
| Primary | Amount of Post-procedure Blood Loss Measured in mL | post-procedure blood loss measured in recovery room | Posted | Mean | 95% Confidence Interval | mL | measured 1 to 2 hours after procedure |
|
|
|
|
| Primary | 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 | Posted | Count of Participants | Participants | duration of procedure and until discharged from hospital |
|
|
|
|
| Primary | Number of Participants Who Returned to OR for Re-aspiration During Recovery Period | Returned to OR for re-aspiration | Posted | Count of Participants | Participants | from cervical preparation through discharge |
|
|
|
|
| Primary | Number of Participants Who Were Admitted for Bleeding After Procedure | hospital admission for bleeding post-procedure | Posted | Count of Participants | Participants | post-procedure and during recovery until discharge |
|
|
|
|
| Primary | Number of Participants Given Any Uterotonic | any uterotonic medication given intraoperative or postoperative | Posted | Count of Participants | Participants | intra-operative or post-operative until discharge |
|
|
|
|
| Secondary | Number of Participants Who Reported Nausea up to One Hour After Procedure | Patients' completed survey regarding side effects in recovery room. | Posted | Count of Participants | Participants | Assessed approximately 1 hour after procedure |
|
|
|
|
| Secondary | Number of Patients Who Reported Vomiting up to One Hour After Procedure | Patients' completed survey regarding side effects in recovery room. | Posted | Count of Participants | Participants | Assessed approximately 1 hour after procedure |
|
|
|
|
| Secondary | Number of Participants Who Reported Cramping up to One Hour After Procedure | Patients' completed survey regarding side effects in recovery room. | Posted | Count of Participants | Participants | Assessed approximately 1 hour after procedure |
|
|
|
|
| 140 |
| 4 |
| 140 |
| 20 |
| 140 |
| EG001 | Placebo | Placebo group | 0 | 144 | 0 | 144 | 11 | 144 |
| reasperation | Reproductive system and breast disorders | Non-systematic Assessment |
|
| transfusion | Reproductive system and breast disorders | Non-systematic Assessment |
|
| uterine artery embolization | Reproductive system and breast disorders | Non-systematic Assessment |
|
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| Heterocyclic Compounds |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |