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| Name | Class |
|---|---|
| Society of Family Planning | OTHER |
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The purpose of this study is to compare the dilatory effect of 400 mcg of buccally administered misoprostol to one Dilapan-S rod placed 3-4 hours before abortion by dilation and evacuation in women who are 12 weeks 0 days to 15 weeks 0 days gestation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | 400mcg buccal misoprostol |
|
| 2 | Experimental | Dilapan-S, control: vitamin B-12 administered sublingually |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| misoprostol | Drug | 400mcg misoprostol, buccal administration, 1 time dosing 3-4 hours before abortion by D&E |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cervical Dilation in Women Following Exposure to Either Ripening Agent | 3-4 hours after placement of ripening agent |
| Measure | Description | Time Frame |
|---|---|---|
| Ease of Further Mechanical Dilation in Women Following Exposure to Either Ripening Agent, as Per MD Report | Scale: None needed (score of 0) Very easy (score 1) Somewhat easy (score of 2) Moderate (score of 3) Somewhat difficult (score of 4) Very difficult (score of 5) | 3-4 hours after placement of ripening agent |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Prinicpal Investigator | Planned Parenthood League of Massachusetts | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Planned Parenthood League of Massachusetts | Boston | Massachusetts | 02215 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34061352 | Derived | Ghosh J, Papadopoulou A, Devall AJ, Jeffery HC, Beeson LE, Do V, Price MJ, Tobias A, Tuncalp O, Lavelanet A, Gulmezoglu AM, Coomarasamy A, Gallos ID. Methods for managing miscarriage: a network meta-analysis. Cochrane Database Syst Rev. 2021 Jun 1;6(6):CD012602. doi: 10.1002/14651858.CD012602.pub2. | |
| 23743471 | Derived |
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Patients were recruited for study participation on the day of their pregnancy termination procedure. All study procedures occurred on the day that the patient was enrolled.
Dates of recruitment period: January 2009 - December 2011 We recruited English- or Spanish-speaking women who were in good health, at least 18 years old, and between 12 weeks 0 days and 15 weeks 0 days gestation by ultrasound examination, seeking outpatient pregnancy termination at Planned Parenthood League of MA.
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| ID | Title | Description |
|---|---|---|
| FG000 | Misoprostol | 400mcg buccal misoprostol misoprostol : 400mcg misoprostol, buccal administration, 1 time dosing 3-4 hours before abortion by D&E |
| FG001 | Synthetic Osmotic Dilator | Dilapan-S, control: vitamin B-12 administered sublingually Dilapan-S, vitamin B-12 : One Dilapan-S rod placed in the cervix 3-4 hours before abortion by D&E. Control: 1000mcg vitamin B-12, buccal administration 3-4 hours before abortion by D&E |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Misoprostol | 400mcg buccal misoprostol misoprostol : 400mcg misoprostol, buccal administration, 1 time dosing 3-4 hours before abortion by D&E |
| BG001 | Synthetic 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 | Cervical Dilation in Women Following Exposure to Either Ripening Agent | Posted | Mean | Standard Deviation | mm | 3-4 hours after placement of ripening agent |
|
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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 | Misoprostol | 400mcg buccal misoprostol misoprostol : 400mcg misoprostol, buccal administration, 1 time dosing 3-4 hours before abortion by D&E |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Same-day re-evacuation | Reproductive system and breast disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Principal Investigator | Planned Parenthood League of Massachusetts | 6176161600 |
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| ID | Term |
|---|---|
| D016595 | Misoprostol |
| ID | Term |
|---|---|
| D011459 | Prostaglandins E, Synthetic |
| D011465 | Prostaglandins, Synthetic |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
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| Dilapan-S, vitamin B-12 | Device | One Dilapan-S rod placed in the cervix 3-4 hours before abortion by D&E. Control: 1000mcg vitamin B-12, buccal administration 3-4 hours before abortion by D&E |
|
| Procedure Time for Dilation and Evacuation |
| 3-4 hours after placement of ripening agent |
| Number of Patients for Whom Physician Was Able to Complete Dilation and Evacuation Procedure on First Attempt | 3-4 hours after placement of ripening agent |
| Subject Pain During Ripening | Measure assesses patient pain during cervical preparation. Pain was assessed after cervical ripening was complete, immediately before D&E procedure. Subjects were asked to rate pain on a 6 point Likert scale: 0 = no pain 1-2 = mild pain 3 = moderate pain 4-5 = severe pain Higher values represent a worse outcome. | 3-4 hours after placement of ripening agent |
| Subject Pain During Dilation and Evacuation | Measure assesses subject pain during dilation and evacuation. Pain was assessed immediately after the D&E procedure. Subjects were asked to rate pain on a 6 point Likert scale: 0 = no pain 1-2 = mild pain 3 = moderate pain 4-5 = severe pain Higher values represent a worse outcome. | 3-4 hours after placement of ripening agent |
| Women's Satisfaction With Cervical Ripening Method | Scale: 1 = very dissatisfied, 2 = dissatisfied, 3 = neutral, 4 = satisfied, 5 = very satisfied | 5 hours after placement of ripening agent |
| Bartz D, Maurer R, Allen RH, Fortin J, Kuang B, Goldberg AB. Buccal misoprostol compared with synthetic osmotic cervical dilator before surgical abortion: a randomized controlled trial. Obstet Gynecol. 2013 Jul;122(1):57-63. doi: 10.1097/AOG.0b013e3182983889. |
Dilapan-S, control: vitamin B-12 administered sublingually
Dilapan-S, vitamin B-12 : One Dilapan-S rod placed in the cervix 3-4 hours before abortion by D&E.
Control: 1000mcg vitamin B-12, buccal administration 3-4 hours before abortion by D&E
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Ease of Further Mechanical Dilation in Women Following Exposure to Either Ripening Agent, as Per MD Report | Scale: None needed (score of 0) Very easy (score 1) Somewhat easy (score of 2) Moderate (score of 3) Somewhat difficult (score of 4) Very difficult (score of 5) | Posted | Count of Participants | Participants | 3-4 hours after placement of ripening agent |
|
|
|
| Secondary | Procedure Time for Dilation and Evacuation | Posted | Median | Inter-Quartile Range | minutes | 3-4 hours after placement of ripening agent |
|
|
|
| Secondary | Number of Patients for Whom Physician Was Able to Complete Dilation and Evacuation Procedure on First Attempt | Posted | Number | participants | 3-4 hours after placement of ripening agent |
|
|
|
| Secondary | Subject Pain During Ripening | Measure assesses patient pain during cervical preparation. Pain was assessed after cervical ripening was complete, immediately before D&E procedure. Subjects were asked to rate pain on a 6 point Likert scale: 0 = no pain 1-2 = mild pain 3 = moderate pain 4-5 = severe pain Higher values represent a worse outcome. | Posted | Median | Inter-Quartile Range | Scores on a scale | 3-4 hours after placement of ripening agent |
|
|
|
| Secondary | Subject Pain During Dilation and Evacuation | Measure assesses subject pain during dilation and evacuation. Pain was assessed immediately after the D&E procedure. Subjects were asked to rate pain on a 6 point Likert scale: 0 = no pain 1-2 = mild pain 3 = moderate pain 4-5 = severe pain Higher values represent a worse outcome. | Posted | Median | Inter-Quartile Range | Scores on a scale | 3-4 hours after placement of ripening agent |
|
|
|
| Secondary | Women's Satisfaction With Cervical Ripening Method | Scale: 1 = very dissatisfied, 2 = dissatisfied, 3 = neutral, 4 = satisfied, 5 = very satisfied | Posted | Median | Inter-Quartile Range | units on a scale | 5 hours after placement of ripening agent |
|
|
|
| 0 |
| 62 |
| 3 |
| 62 |
| EG001 | Synthetic Osmotic Dilator | Dilapan-S, control: vitamin B-12 administered sublingually Dilapan-S, vitamin B-12 : One Dilapan-S rod placed in the cervix 3-4 hours before abortion by D&E. Control: 1000mcg vitamin B-12, buccal administration 3-4 hours before abortion by D&E | 0 | 60 | 3 | 60 |
| Hemorrhage | Reproductive system and breast disorders | estimated blood loss of 300 cc |
|
| Cervical laceration | Reproductive system and breast disorders | minor, treated with cervical pressure |
|
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| D005231 |
| Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |
| Moderate (score of 3) |
|
| Somewhat-very difficult (score of 4-5) |
|