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inadequate enrollment
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One the day prior to medical abortion (labor induction) in the second trimester, insertion of osmotic dilators is added to the routine procedures. The study is to see whether the addition of dilators decreases the abortion time (time for the pregnancy to be expelled)
This is a pilot study and is an uncontrolled, non-randomized series. Women having a medical abortion in second trimester undergo several procedures the day before the medication to cause contractions occurs. On the day before admission, they take mifepristone orally, and have a feticidal injection. to this would be added the insertion of cervical osmotic dilators (the intervention). On the day of induction, the dilators would be removed and misoprostol started to cause contractions. We are hoping the median abortion time will drop from the present 9-10 hours to 4-6 hours. women who do not abort in 6 hours will have option of surgical completion of the abortion (dilation and evacuation) if medically appropriate.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| osmotic dilator | Experimental | osmotic dilator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| osmotic dilator insertion | Device | osmotic dilators are placed in the cervix to cause cervical dilation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Length of Medical Abortion | This is the time elapsed from the first dose of misoprostol (the agent to induce abortion) and expulsion of the fetus | hours since the start of medical abortion |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lynn Borgatta, MD, MPH | Boston University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boston Medical Center | Boston | Massachusetts | 02118 | United States |
Women were eligible for study intervention if they had singleton pregnancy with intact membranes, without signs of infection.
Women requesting abortion at 19-23 weeks were eligible to enroll if they were able to consent and had no contraindications to medical abortion. Women were informed of the study after all counseling for abortion was completed and after they had given consent for abortion
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| ID | Title | Description |
|---|---|---|
| FG000 | Osmotic Dilator | osmotic dilator |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Osmotic Dilator | osmotic dilator |
| 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 Medical Abortion | This is the time elapsed from the first dose of misoprostol (the agent to induce abortion) and expulsion of the fetus | Posted | Mar 2011 | Mean | Standard Deviation | hours | hours since the start of medical abortion |
|
|
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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 | Osmotic Dilator | osmotic dilator |
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The study was terminated early because the clinical facility changed and eligible patients were not seen at the facility.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lynn Borgatta, MD | Boston University | 617-414-3440 | lynn.borgatta@bmc.org |
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| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 0 |
| 4 |
| 0 |
| 4 |
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