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| ID | Type | Description | Link |
|---|---|---|---|
| AU 6003109 | Other Grant/Funding Number | Society of Family Planning |
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| Name | Class |
|---|---|
| Society of Family Planning | OTHER |
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In this study the investigators plan to compare mifepristone and misoprostol use to osmotic dilator use for cervical preparation for 15-18 week surgical abortion. Mifepristone would be given 24 hours prior to abortion, and misoprostol 400 mcg would be administered buccally 2 hours prior to abortion. Osmotic dilators are the method currently used in our institution, and are placed 24 hours prior to abortion. The primary outcome will be the length of the procedure. Secondary outcomes will include amount of dilation achieved, ease of procedure, participant's assessment of discomfort before mifepristone or dilators, discomfort during the abortion procedure, acceptability to participants, and acceptability to staff.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mifepristone + misoprostol | Experimental | Mifepristone 200 mg PO given 20-24 hours prior to procedure, misoprostol 400 mcg given 2 hours prior to procedure |
|
| Osmotic dilators | Active Comparator | Placed 20-24 hours prior to procedure |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mifepristone | Drug | 200 mg po 20-24 hours prior to the procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| Length of Procedure | Interval from speculum insertion to speculum removal | Subjects will be followed from the administration of mifepristone/misoprostol or laminaria, until the end of their procedure, a total of two days. |
| Measure | Description | Time Frame |
|---|---|---|
| Operative Time | Interval from initiation of vacuum aspiration to speculum removal | Subjects will be followed from the administration of mifepristone/misoprostol, or laminaria, until the end of their procedure, a total of two days. |
| Subject Discomfort Before the Abortion |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sarita Sonalkar, MD | Boston Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boston University | Boston | Massachusetts | 02130 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Mifepristone + Misoprostol | Mifepristone 200 mg PO given 20-24 hours prior to procedure, misoprostol 400 mcg given 2 hours prior to procedure Mifepristone: 200 mg po 20-24 hours prior to the procedure |
| FG001 | Osmotic Dilators | Placed 20-24 hours prior to procedure osmotic dilators: osmotic dilators placed in the cervix 20-24 hours prior to the procedure |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Mifepristone + Misoprostol | Mifepristone 200 mg PO given 20-24 hours prior to procedure, misoprostol 400 mcg given 2 hours prior to procedure |
| BG001 | Osmotic Dilators | Placed 20-24 hours prior to procedure |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Length of Procedure | Interval from speculum insertion to speculum removal | Posted | Mean | 95% Confidence Interval | minutes | Subjects will be followed from the administration of mifepristone/misoprostol or laminaria, until the end of their procedure, a total of two days. |
|
12 months
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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 | Mifepristone + Misoprostol | Mifepristone 200 mg PO given 20-24 hours prior to procedure, misoprostol 400 mcg given 2 hours prior to procedure Mifepristone: 200 mg po 20-24 hours prior to the procedure |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Olivera Vragovic | Boston Medical Center | 617 414 7304 | Olivera.Vragovic@bmc.org |
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| ID | Term |
|---|---|
| D015735 | Mifepristone |
| ID | Term |
|---|---|
| D004963 | Estrenes |
| D004962 | Estranes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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| osmotic dilators | Device | osmotic dilators placed in the cervix 20-24 hours prior to the procedure |
|
|
Pain was subjectively described by the subjects as : None, Mild, Moderate, Severe |
| Subjects will be followed from the administration of mifepristone/misoprostol, or laminaria, until the end of their procedure, a total of two days. |
| Pain Medication (Fentanyl) During the Abortion | Amount of pain medication used during the procedure: reported as micrograms of fentanyl | Subjects will be followed from the administration of mifepristone/misoprostol, or laminaria, until the end of their procedure, a total of two days. |
| Pain Medication (Midazolam) During the Abortion | Amount of pain medication used during the procedure: reported as milligrams of midazolam | Subjects will be followed from the administration of mifepristone/misoprostol, or laminaria, until the end of their procedure, a total of two days. |
| Cervical Dilation Achieved | Cervical dilation at start of procedure | At time of abortion |
| Acceptability to Patient | Patient was asked whether they would choose to be in the same group again if they had a similar procedure again. The number of participants whose response was "yes" is being reported. | After procedure completion |
| Difficulty of Procedure | Outcome measure is the number and percentage of participants where the provider rated the procedure as "difficult or very difficult". Provider assessment of difficulty of procedure categories were: "very easy", "easy", "moderate", "difficult", or "very difficult." | After completion of procedure |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| Secondary | Operative Time | Interval from initiation of vacuum aspiration to speculum removal | Posted | Median | 95% Confidence Interval | minutes | Subjects will be followed from the administration of mifepristone/misoprostol, or laminaria, until the end of their procedure, a total of two days. |
|
|
|
| Secondary | Subject Discomfort Before the Abortion | Pain was subjectively described by the subjects as : None, Mild, Moderate, Severe | Posted | Number | participants | Subjects will be followed from the administration of mifepristone/misoprostol, or laminaria, until the end of their procedure, a total of two days. |
|
|
|
| Secondary | Pain Medication (Fentanyl) During the Abortion | Amount of pain medication used during the procedure: reported as micrograms of fentanyl | Posted | Mean | Standard Deviation | mcg | Subjects will be followed from the administration of mifepristone/misoprostol, or laminaria, until the end of their procedure, a total of two days. |
|
|
|
| Secondary | Pain Medication (Midazolam) During the Abortion | Amount of pain medication used during the procedure: reported as milligrams of midazolam | Posted | Mean | Standard Deviation | mg | Subjects will be followed from the administration of mifepristone/misoprostol, or laminaria, until the end of their procedure, a total of two days. |
|
|
|
| Secondary | Cervical Dilation Achieved | Cervical dilation at start of procedure | Posted | Mean | Standard Deviation | mm | At time of abortion |
|
|
|
| Secondary | Acceptability to Patient | Patient was asked whether they would choose to be in the same group again if they had a similar procedure again. The number of participants whose response was "yes" is being reported. | Posted | Count of Participants | Participants | After procedure completion |
|
|
|
| Secondary | Difficulty of Procedure | Outcome measure is the number and percentage of participants where the provider rated the procedure as "difficult or very difficult". Provider assessment of difficulty of procedure categories were: "very easy", "easy", "moderate", "difficult", or "very difficult." | Posted | Count of Participants | Participants | After completion of procedure |
|
|
|
| 0 |
| 30 |
| 0 |
| 30 |
| 0 |
| 30 |
| EG001 | Osmotic Dilators | Placed 20-24 hours prior to procedure osmotic dilators: osmotic dilators placed in the cervix 20-24 hours prior to the procedure | 0 | 20 | 0 | 20 | 0 | 20 |
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| D011083 |
| Polycyclic Compounds |
| Moderate |
|
| Severe |
|