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A randomized double---blinded comparison of same---day mifepristone and misoprostol with misoprostol only for cervical preparation in second---trimester surgical abortion in 100 women at 14 0/7---19 6/7 weeks gestation.
Women desiring abortion at gestational ages between 14 weeks 0 days and 19 weeks 6 days were randomized to 200-mg mifepristone or identical placebo with 400-mcg misoprostol vaginally 4-6 hours prior to D&E. Primary outcome was cervical dilation assessed by the largest Hegar dilator accepted without resistance. Secondary outcomes included total procedure time, and patient and provider perceptions. The study was powered to detect a 2-mm difference in cervical dilatation with 48 participants in each arm.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mifepristone | Active Comparator | Mifepristone 200mg oral tablet, once Misoprostol 400 mcg tablets, vaginally, once |
|
| Placebo | Placebo Comparator | Placebo oral tablets, odorless, colorless and matched to Mifepristone appearance Misoprostol 400 mcg tablets, vaginally, once |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mifepristone | Drug | Progesterone antagonist |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Initial Cervical Dilation | Initial cervical dilation as measured by Hegar Dilator accepted with least resistance | Assessed 4-6 hour following medications at time of D&E procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Acceptability and Assessment of Pain and Side Effects (5-point Likert Scale) | 5-point Likert scale given to patients following procedure once recovered from anesthesia assessing pain, side effects including nausea, vomiting, diarrhea, cramping, and if they would choose the method again or recommend to friends. Likert scale: Strongly agree (5), Agree (4), Neutral (3), Disagree (2), Strongly Disagree (1) |
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Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26948184 | Derived | Casey FE, Ye PP, Perritt JD, Moreno-Ruiz NL, Reeves MF. A randomized controlled trial evaluating same-day mifepristone and misoprostol compared to misoprostol alone for cervical preparation prior to second-trimester surgical abortion. Contraception. 2016 Aug;94(2):127-33. doi: 10.1016/j.contraception.2016.02.032. Epub 2016 Mar 4. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Mifepristone | Mifepristone 200mg oral tablet, once Misoprostol 400 mcg tablets, vaginally, once Mifepristone: Progesterone antagonist Misoprostol: Prostaglandin E1 |
| FG001 | Placebo | Placebo oral tablets, odorless, colorless and matched to Mifepristone appearance Misoprostol 400 mcg tablets, vaginally, once Placebo: Tasteless, odorless, sugar based pill Misoprostol: Prostaglandin E1 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Mifepristone | Mifepristone 200mg oral tablet, once Misoprostol 400 mcg tablets, vaginally, once Mifepristone: Progesterone antagonist Misoprostol: Prostaglandin E1 |
| BG001 | Placebo |
| 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 | Initial Cervical Dilation | Initial cervical dilation as measured by Hegar Dilator accepted with least resistance | Posted | Mean | 95% Confidence Interval | mm | Assessed 4-6 hour following medications at time of D&E 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 | Placebo | Placebo oral tablets, odorless, colorless and matched to Mifepristone appearance Misoprostol 400 mcg tablets, vaginally, once Placebo: Tasteless, odorless, sugar based pill Misoprostol: Prostaglandin E1 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Frances Casey | VCU Medical Center | 804-828-7877 | frances.casey@vcuhealth.org |
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| ID | Term |
|---|---|
| D015735 | Mifepristone |
| D016595 | Misoprostol |
| ID | Term |
|---|---|
| D004963 | Estrenes |
| D004962 | Estranes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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| Misoprostol | Drug | Prostaglandin E1 |
|
|
| Placebo | Dietary Supplement | Tasteless, odorless, sugar based pill |
|
| intraoperative |
Placebo oral tablets, odorless, colorless and matched to Mifepristone appearance Misoprostol 400 mcg tablets, vaginally, once
Misoprostol: Prostaglandin E1
Placebo: Tasteless, odorless, sugar based pill
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex/Gender, Customized | Number | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Patient Acceptability and Assessment of Pain and Side Effects (5-point Likert Scale) | 5-point Likert scale given to patients following procedure once recovered from anesthesia assessing pain, side effects including nausea, vomiting, diarrhea, cramping, and if they would choose the method again or recommend to friends. Likert scale: Strongly agree (5), Agree (4), Neutral (3), Disagree (2), Strongly Disagree (1) | Posted | Mean | Full Range | units on a scale | intraoperative |
|
|
|
| 0 |
| 48 |
| 0 |
| 48 |
| 0 |
| 48 |
| EG001 | Mifepristone | Mifepristone 200mg oral tablet, once Misoprostol 400 mcg tablets, vaginally, once Mifepristone: Progesterone antagonist Misoprostol: Prostaglandin E1 | 0 | 48 | 0 | 48 | 0 | 48 |
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| 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 |