| ID | Type | Description | Link |
|---|---|---|---|
| SFPRF6-MS | Other Grant/Funding Number | Society for Family Planning Research Fund |
Not provided
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| Name | Class |
|---|---|
| Society of Family Planning | OTHER |
Not provided
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The purpose of this research study is to compare three different ways of opening a woman's cervix before her second-trimester surgical abortion.
Hypotheses:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Osmotic dilators + placebo (vit c) + placebo (vit B12) | Other | Women will receive osmotic dilators on Day 1, oral placebo on Day 1, and buccal placebo on Day 2. |
|
| Osmotic dilators + placebo (vit c) + misoprostol | Active Comparator | Women will receive osmotic dilators on Day 1, oral placebo on Day 1, and buccal misoprostol 400 mcg on Day 2. |
|
| Osmotic dilators + mifepristone + placebo (vit B12) | Active Comparator | Women will receive osmotic dilators on Day 1, oral mifepristone 200 mg on Day 1, and buccal placebo on Day 2. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mifepristone | Other | oral mifepristone 200 mg on Day 1. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Operative Time | The duration of the D&E procedure was measured with a stopwatch, starting with the first instrument that passes into the uterus and ending when the last instrument is removed from the uterus upon completion of the D&E | participants were assessed for the duration of the procedure, an average of 6 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Initial Cervical Dilation | Measured at the time of procedure (immediately before the start of D&E) | participants were assessed during cervical dilation process, average time of 1 minute |
| Ability to Complete the D&E on the First Attempt |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Principal Investigator, MD, MPH | Planned Parenthood League of Massachusetts | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Francisco General Hospital | San Francisco | California | 94110 | United States | ||
| Family Planning Associates |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26196084 | Derived | Goldberg AB, Fortin JA, Drey EA, Dean G, Lichtenberg ES, Bednarek PH, Chen BA, Dutton C, McKetta S, Maurer R, Winikoff B, Fitzmaurice GM. Cervical Preparation Before Dilation and Evacuation Using Adjunctive Misoprostol or Mifepristone Compared With Overnight Osmotic Dilators Alone: A Randomized Controlled Trial. Obstet Gynecol. 2015 Sep;126(3):599-609. doi: 10.1097/AOG.0000000000000977. |
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Recruitment period: February 2013-February 2014
Number of recruitment sites: 7
Types of location: medical clinic (3), hospital-based (4)
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Osmotic Dilators + Placebo (Vit c) + Placebo (Vit B12) | Women will receive osmotic dilators on Day 1, oral placebo on Day 1, and buccal placebo on Day 2. Osmotic dilators: osmotic dilators on Day 1 placebo: placebo for mifepristone, on day 1 placebo: placebo for misoprostol, on day 2 |
| FG001 | Osmotic Dilators + Placebo (Vit c) + Misoprostol | Women will receive osmotic dilators on Day 1, oral placebo on Day 1, and buccal misoprostol 400 mcg on Day 2. misoprostol: buccal misoprostol 400 mcg on Day 2 Osmotic dilators: osmotic dilators on Day 1 placebo: placebo for mifepristone, on day 1 |
| FG002 | Osmotic Dilators + Mifepristone + Placebo (Vit B12) | Women will receive osmotic dilators on Day 1, oral mifepristone 200 mg on Day 1, and buccal placebo on Day 2. Mifepristone: oral mifepristone 200 mg on Day 1. Osmotic dilators: osmotic dilators on Day 1 placebo: placebo for misoprostol, on day 2 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
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| ID | Title | Description |
|---|---|---|
| BG000 | Osmotic Dilators + Placebo (Vit c) + Placebo (Vit B12) | Women will receive osmotic dilators on Day 1, oral placebo on Day 1, and buccal placebo on Day 2. Osmotic dilators: osmotic dilators on Day 1 placebo: placebo for mifepristone, on day 1 placebo: placebo for misoprostol, on day 2 |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Operative Time | The duration of the D&E procedure was measured with a stopwatch, starting with the first instrument that passes into the uterus and ending when the last instrument is removed from the uterus upon completion of the D&E | Arm 1 (dilators-alone): 1 subject excluded [withdrawn/no intervention]. Arm 2 (dilators + misoprostol): 2 excluded: [one expelled, no D&E, one D&E not completed on first attempt & data missing]. Arm 3 (dilators + mifepristone): 2 excluded (1 withdrawn/no intervention, 1 D&E not completed on first attempt & data missing]. | Posted | Mean | Standard Deviation | minutes | participants were assessed for the duration of the procedure, an average of 6 minutes |
|
1 month post-procedure
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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 Dilators + Placebo (Vit c) + Placebo (Vit B12) | Women will receive osmotic dilators on Day 1, oral placebo on Day 1, and buccal placebo on Day 2. Osmotic dilators: osmotic dilators on Day 1 placebo: placebo for mifepristone, on day 1 placebo: placebo for misoprostol, on day 2 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalization for bleeding | Reproductive system and breast disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| uterine re-aspiration | Reproductive system and breast disorders | Systematic Assessment |
Limitations include inadequate sample size to measure complications as a primary outcome and reliance on outcomes that measure efficacy of the cervical preparation rather than its direct effect on overall safety.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Principal Investigator | Planned Parenthood League of Massachusetts, Inc. | 617.616.1600 |
Not provided
| ID | Term |
|---|---|
| D015735 | Mifepristone |
| D016595 | Misoprostol |
| D001205 | Ascorbic Acid |
| D014805 | Vitamin B 12 |
| ID | Term |
|---|---|
| D004963 | Estrenes |
| D004962 | Estranes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
Not provided
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| misoprostol | Drug | buccal misoprostol 400 mcg on Day 2 |
|
|
| Osmotic dilators | Device | osmotic dilators on Day 1 |
|
|
| placebo | Other | placebo for mifepristone, on day 1 |
|
|
| placebo | Other | placebo for misoprostol, on day 2 |
|
|
Assessed on day of procedure and following day. If the procedure was unable to be completed as planned and the subject had to leave the procedure room and return for another attempt either at a time later the same day or the next day.
| participants were assessed for the duration of the procedure, an average of 6 minutes |
| Need for Mechanical Dilation | Assessed on Day of procedure. Assessed immediately after completion of D&E | participants were assessed for the duration of the procedure, an average of 6 minutes |
| Ease of Mechanical Dilation | Number of participants for whom, if additional mechanical dilation was required, it was difficult or very difficult. Assessed on day of procedure. Assessed after completion of D&E | participants were assessed for the duration of the procedure, an average of 6 minutes |
| Complications From Procedure | Patient having any complication, including hospitalizations transfusions additional unplanned procedures | assessed immediately after completion of D&E and at 1 week and 1 month post-procedure |
| Chills (Any) After Day 2 Medication Administration | chills (any) after Day 2 medication administration | assessed immediately after administration of day 2 medication |
| Patient Satisfaction With Cervical Prep | Patients who were very satisfied or satisfied with cervical preparation. Assessed on Day of procedure. Assessed after completion of D&E procedure and just prior to discharge home. | patients' satisfaction with cervical prep was evaluated over course of cervical prep and procedure, up to 3 days |
| Physician Satisfaction With Cervical Preparation | Participants for whom the operating physician reported being satisfied or very satisfied with the cervical preparation. Assessed on Day of procedure. Assessed after completion of D&E procedure. | physicians' satisfaction with cervical prep was evaluated over course of procedure, an average of 6 minutes |
| Chicago |
| Illinois |
| 60630 |
| United States |
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States |
| Boston Medical Center | Boston | Massachusetts | 02118 | United States |
| Planned Parenthood of New York City | New York | New York | 10012 | United States |
| Lovejoy Surgical Center | Portland | Oregon | 97210 | United States |
| Magee Women's Hospital | Pittsburgh | Pennsylvania | 15213 | United States |
| Osmotic Dilators + Placebo (Vit c) + Misoprostol |
Women will receive osmotic dilators on Day 1, oral placebo on Day 1, and buccal misoprostol 400 mcg on Day 2. misoprostol: buccal misoprostol 400 mcg on Day 2 Osmotic dilators: osmotic dilators on Day 1 placebo: placebo for mifepristone, on day 1 |
| BG002 | Osmotic Dilators + Mifepristone + Placebo (Vit B12) | Women will receive osmotic dilators on Day 1, oral mifepristone 200 mg on Day 1, and buccal placebo on Day 2. Mifepristone: oral mifepristone 200 mg on Day 1. Osmotic dilators: osmotic dilators on Day 1 placebo: placebo for misoprostol, on day 2 |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Osmotic Dilators + Placebo (Vit c) + Misoprostol | Women will receive osmotic dilators on Day 1, oral placebo on Day 1, and buccal misoprostol 400 mcg on Day 2. misoprostol: buccal misoprostol 400 mcg on Day 2 Osmotic dilators: osmotic dilators on Day 1 placebo: placebo for mifepristone, on day 1 |
| OG002 | Osmotic Dilators + Mifepristone + Placebo (Vit B12) | Women will receive osmotic dilators on Day 1, oral mifepristone 200 mg on Day 1, and buccal placebo on Day 2. Mifepristone: oral mifepristone 200 mg on Day 1. Osmotic dilators: osmotic dilators on Day 1 placebo: placebo for misoprostol, on day 2 |
|
|
| Secondary | Initial Cervical Dilation | Measured at the time of procedure (immediately before the start of D&E) | Arm 1: 1 subject excluded [withdrawn/no intervention]. Arm 2: 2 excluded: [one expelled, no D&E, one D&E not completed on first attempt & data missing]. Arm 3: 2 excluded (1 withdrawn/no intervention, 1 D&E not completed on first attempt & data missing]. Additionally missing data for one more subject in Arm 2. | Posted | Mean | Standard Deviation | centimeters | participants were assessed during cervical dilation process, average time of 1 minute |
|
|
|
| Secondary | Ability to Complete the D&E on the First Attempt | Assessed on day of procedure and following day. If the procedure was unable to be completed as planned and the subject had to leave the procedure room and return for another attempt either at a time later the same day or the next day. | Posted | Number | participants | participants were assessed for the duration of the procedure, an average of 6 minutes |
|
|
|
| Secondary | Need for Mechanical Dilation | Assessed on Day of procedure. Assessed immediately after completion of D&E | Arm 1: one subject withdrawn/no intervention. Arm 2: one subject expelled, no D&E. Arm 3: one subject withdrawn/no intervention | Posted | Number | 95% Confidence Interval | participants | participants were assessed for the duration of the procedure, an average of 6 minutes |
|
|
|
| Secondary | Ease of Mechanical Dilation | Number of participants for whom, if additional mechanical dilation was required, it was difficult or very difficult. Assessed on day of procedure. Assessed after completion of D&E | Number of participants in each arm who required additional mechanical dilation | Posted | Number | participants | participants were assessed for the duration of the procedure, an average of 6 minutes |
|
|
|
| Secondary | Complications From Procedure | Patient having any complication, including hospitalizations transfusions additional unplanned procedures | Posted | Number | participants | assessed immediately after completion of D&E and at 1 week and 1 month post-procedure |
|
|
|
| Secondary | Chills (Any) After Day 2 Medication Administration | chills (any) after Day 2 medication administration | Posted | Number | 95% Confidence Interval | participants | assessed immediately after administration of day 2 medication |
|
|
|
| Secondary | Patient Satisfaction With Cervical Prep | Patients who were very satisfied or satisfied with cervical preparation. Assessed on Day of procedure. Assessed after completion of D&E procedure and just prior to discharge home. | Posted | Number | participants | patients' satisfaction with cervical prep was evaluated over course of cervical prep and procedure, up to 3 days |
|
|
|
| Secondary | Physician Satisfaction With Cervical Preparation | Participants for whom the operating physician reported being satisfied or very satisfied with the cervical preparation. Assessed on Day of procedure. Assessed after completion of D&E procedure. | Data on whether the physician was satisfied with the cervical preparation is available for all participants except: Arm 1: 1 participant withdrawn with no intervention; Arm 2: 1 participant who didn't have a D&E (expelled), Arm 3: 1 participant withdrawn with no intervention and one with missing data. | Posted | Number | 95% Confidence Interval | participants | physicians' satisfaction with cervical prep was evaluated over course of procedure, an average of 6 minutes |
|
|
|
| 2 |
| 99 |
| 8 |
| 99 |
| EG001 | Osmotic Dilators + Placebo (Vit c) + Misoprostol | Women will receive osmotic dilators on Day 1, oral placebo on Day 1, and buccal misoprostol 400 mcg on Day 2. misoprostol: buccal misoprostol 400 mcg on Day 2 Osmotic dilators: osmotic dilators on Day 1 placebo: placebo for mifepristone, on day 1 | 1 | 100 | 1 | 100 |
| EG002 | Osmotic Dilators + Mifepristone + Placebo (Vit B12) | Women will receive osmotic dilators on Day 1, oral mifepristone 200 mg on Day 1, and buccal placebo on Day 2. Mifepristone: oral mifepristone 200 mg on Day 1. Osmotic dilators: osmotic dilators on Day 1 placebo: placebo for misoprostol, on day 2 | 1 | 99 | 1 | 99 |
| Hospitalization for bleeding + Hysterectomy | Reproductive system and breast disorders | Systematic Assessment |
|
| Intrauterine tamponade or cervical stay sutures | Reproductive system and breast disorders | Systematic Assessment |
|
| cervical laceration requiring sutures | Reproductive system and breast disorders | Systematic Assessment |
|
Not provided
Not provided
| D011083 |
| Polycyclic Compounds |
| D011459 | Prostaglandins E, Synthetic |
| D011465 | Prostaglandins, Synthetic |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |
| D013400 | Sugar Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D006880 | Hydroxy Acids |
| D002241 | Carbohydrates |
| D045728 | Corrinoids |
| D045725 | Tetrapyrroles |
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D047028 | Macrocyclic Compounds |