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| Name | Class |
|---|---|
| Society of Family Planning | OTHER |
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Women who are requesting pregnancy termination at 14-16 weeks, who would normally have osmotic dilator insertion the day before their procedure, would be asked if they wanted to participate. Participants would be randomized to two groups: first, dilator insertion as usual, or second, mifepristone taken the day before the procedure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| mifepristone | Experimental | women in the mifepristone are would take mifepristone 200 mg for cervical preparation the day before their procedure, and not have dilators inserted. In this group, the sstandard procedure of osmotic dilator insertion is NOT performed. |
|
| Osmotic dilator insertion | Active Comparator | Women assigned to this arm would have the standard procedure for cervical preparation, which is insertion of osmotic dilators the day before the abortion procedure |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mifepristone 200 mg | Drug | mifepristone would be given the day before the procedure |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Time for Completion of Procedure | Minutes, from the time of the start of the procedure (speculum insertion) to the conclusion of the procedure (speculum removal) | Performance and completion of the abortion procedure takes 10-20 minutes. The length of the procedure is measured. The procedure occurs approximately 24 hours after enrollment. |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of Ease of Procedure by Operator | The operator for each procedure rated the ease of procedure on a categorical scale. The categories were collapsed into two: "easy or very easy" and "average or difficult". | It is administered shortly after the primary outcome, which is one day after enrollment. The study is complete at that point. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| L B, MD, MPH | Boston University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boston Medical Center | Boston | Massachusetts | 02118 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22682721 | Derived | Borgatta L, Roncari D, Sonalkar S, Mark A, Hou MY, Finneseth M, Vragovic O. Mifepristone vs. osmotic dilator insertion for cervical preparation prior to surgical abortion at 14-16 weeks: a randomized trial. Contraception. 2012 Nov;86(5):567-71. doi: 10.1016/j.contraception.2012.05.002. Epub 2012 Jun 6. |
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All women enrolled were assigned to groups. Group assignment was done very shortly after enrollment.
Patients were recruited from the abortion clinic, after they had already consented to the abortion procedure, October 2009 to March 2011.
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard Osmotic Dilator Insertion | Women assigned to this arm would have the standard procedure, which is insertion of osmotic dilators the day before the procedure. Osmotic dilator insertion : osmotic dilators (3-6) would be inserted as usual the day before the procedure. All women would have the surgical abortion procedure done on the day following osmotic dilator insertion by standard surgical technique. |
| FG001 | Mifepristone | Women in the mifepristone are would take mifepristone 200 mg the day before their procedure, and not have dilators inserted Mifepristone 200 mg : mifepristone would be given the day before the procedure All women would have the surgical abortion procedure done on the day following mifepristone, by standard surgical technique. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard Osmotic Dilators | Women assigned to this arm would have the standard procedure, which is insertion of osmotic dilators the day before the procedure. Osmotic dilator insertion : osmotic dilators (3-6) would be inserted as usual the day before the procedure. All women would have the surgical abortion procedure done on the day following osmotic dilator insertion by standard technique. |
| 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 | Time for Completion of Procedure | Minutes, from the time of the start of the procedure (speculum insertion) to the conclusion of the procedure (speculum removal) | Of the 25 women enrolled in the osmotic dilator group, all had osmotic dilators insertion. One woman aborted spontaneously before the surgical abortion; therefore she did not have an abortion procedure and time could not be obtained. she did contribute information about her experience to that point. | Posted | Mean | 95% Confidence Interval | Minutes | Performance and completion of the abortion procedure takes 10-20 minutes. The length of the procedure is measured. The procedure occurs approximately 24 hours after enrollment. |
|
18 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 | Standard Osmotic Dilators | Women assigned to this arm would have the standard procedure, which is insertion of osmotic dilators the day before the procedure. Osmotic dilator insertion : osmotic dilators (3-6) would be inserted as usual the day before the procedure. All women would have the surgical abortion procedure done on the day following osmotic dilator insertion by standard technique. |
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This study was completed as planned.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Research | Boston University Department of Obstetrics and Gynecology | 617-414-5175 | rstudy@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 dilator insertion |
| Device |
osmotic dilators (3-6) would be inserted as usual the day before the procedure |
|
| Moderate or Severe Pain Overnight | Women wer asked to rank their amount of pain on a catergorical scale. The outcome measure is the number of women experiencing moderate or severe pain overnight (after mifepristone or osmotic dilators, and before the abortions procedure) | Overnight |
| BG001 | Mifepristone | Women in the mifepristone are would take mifepristone 200 mg the day before their procedure, and not have dilators inserted Mifepristone 200 mg : mifepristone would be given the day before the procedure All women would have the surgical abortion procedure done on the day following osmotic dilator insertion by standard technique. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Mifepristone | Women in the mifepristone are would take mifepristone 200 mg the day before their procedure, and not have dilators inserted. No osmotic dilators are used. Mifepristone 200 mg : mifepristone would be given the day before the procedure All women would have the surgical abortion procedure done on the day following osmotic dilator insertion by standard technique. |
|
|
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| Secondary | Assessment of Ease of Procedure by Operator | The operator for each procedure rated the ease of procedure on a categorical scale. The categories were collapsed into two: "easy or very easy" and "average or difficult". | All participants with a completed abortion procedure were rated by the operator as to ease of completing the procedure. The number of women in each group having an abortion procedure rated "easy or very easy" is tabulated | Posted | Number | percentage of participants | It is administered shortly after the primary outcome, which is one day after enrollment. The study is complete at that point. |
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|
|
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| Secondary | Moderate or Severe Pain Overnight | Women wer asked to rank their amount of pain on a catergorical scale. The outcome measure is the number of women experiencing moderate or severe pain overnight (after mifepristone or osmotic dilators, and before the abortions procedure) | All participants are included | Posted | Number | percentage of participants | Overnight |
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|
| 0 |
| 25 |
| 0 |
| 25 |
| EG001 | Mifepristone | Women in the mifepristone are would take mifepristone 200 mg the day before their procedure, and not have dilators inserted Mifepristone 200 mg : mifepristone would be given the day before the procedure All women would have the surgical abortion procedure done on the day following osmotic dilator insertion by standard technique. | 0 | 25 | 0 | 25 |
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| D011083 |
| Polycyclic Compounds |