Trial · NCT01615731
Value of Mifepristone in Cervical Preparation Prior to Dilation and Evacuation 19-24 Weeks
NCT01615731, Not applicable, Completed, Stanford University; results first posted 2015-01-26
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Value of Mifepristone in Cervical Preparation Prior to Dilation and Evacuation 19-24 Weeks. Trials, record NCT01615731. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01615731
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Value of Mifepristone in Cervical Preparation Prior to Dilation and Evacuation 19-24 Weeks
- NCT number
- NCT01615731
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 50 participants, actual
- Lead sponsor
- Stanford University
- Conditions
- Abortion, Induced
- Interventions
- Mifepristone, Hygroscopic cervical dilators, Misoprostol, Intra-amniotic digoxin
- First posted
- 2012-06-11
- Last updated
- 2024-02-13
- Results first posted
- 2015-01-26
- Limitations and caveats
- Failure of randomization with respect to assigning similar numbers of nulliparous women to both groups; inaccurate method for measurement of pre-operative cervical dilation; small size of cohort.
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Procedure Time | Intraoperative Time | Measured as time from speculum insertion to removal |
| Primary | Total Procedure Time | Measured at clinic visits and on OR day, over a 3 day period | |
| Secondary | Maximum Cervical Dilation | Measured intra-operatively | Measured by estimate with bimanual exam and passage of largest dilator immediately prior to procedure. |
| Secondary | Adverse Events (EBL) | Intraoperatively | One adverse event: Estimated Blood Loss |
| Secondary | Ease of Procedure by Blinded Surgeon | Measured Immediately after procedure | Used a Visual Analogue Scale to determine the ease of procedure by blinded surgeon. The VAS ranges from 0-100. 0 being the easiest procedure the surgeon felt they had every performed and 100 being the most difficult procedure imaginable by the surgeon. |
| Secondary | Pain Perceived by Patient | Measured pre-operatively (after misoprostol, immediately before transport to OR) and post-operatively (in recovery room, on average 1.5 hours post-operatively) | Used a Visual Analogue Scale to determine the pain perceived by the patient pre-operatively (after misoprostol, immediately before transport to OR) and post-operatively (in recovery room, on average 1.5 hours post-operatively). The VAS ranges from 0-100. 0 being no pain felt by the patient and 100 being the worst pain imaginable felt by the patient. |
| Secondary | Overall Patient Experience | Measured post operatively (at least 30 minutes, on average 1.5 hours) prior to discharge | Used a Visual Analogue Scale to determine the patient's overall satisfaction with her experience. The VAS ranges from 0-100. 0 being a worse than expected experience, 50 being what the patient expected and 100 being a better than expected experience. |
| Secondary | Adverse Events | Intraoperatively and 2 weeks post operatively | uterine perforation, uterine injury, etc. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Procedure Time | Intraoperative Time | minutes | MEAN | |
| PRIMARY | Total Procedure Time | Measured at clinic visits and on OR day, over a 3 day period | Data missing for two subjects in Mifepristone plus one set of dilators arm. | hours | MEAN |
| SECONDARY | Maximum Cervical Dilation | Measured intra-operatively | Data missing for one subject in Mifepristone plus one set of dilators arm. | participants | NUMBER |
| SECONDARY | Adverse Events (EBL) | Intraoperatively | mL | MEAN | |
| SECONDARY | Ease of Procedure by Blinded Surgeon | Measured Immediately after procedure | units on a scale | MEDIAN | |
| SECONDARY | Pain Perceived by Patient | Measured pre-operatively (after misoprostol, immediately before transport to OR) and post-operatively (in recovery room, on average 1.5 hours post-operatively) | units on a scale | MEDIAN | |
| SECONDARY | Overall Patient Experience | Measured post operatively (at least 30 minutes, on average 1.5 hours) prior to discharge | units on a scale | MEDIAN | |
| SECONDARY | Adverse Events | Intraoperatively and 2 weeks post operatively | participants | NUMBER |
Source ClinicalTrials.gov
Results by group28
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Procedure Time | Two Sets of Dilators | 10.9 | Standard Deviation 5.1 | minutes | |
| Procedure Time | Mifepristone Plus One Set of Dilators | 11.8 | Standard Deviation 5.4 | minutes | |
| Total Procedure Time | Two Sets of Dilators | 165 | Standard Deviation 57 | hours | |
| Total Procedure Time | Mifepristone Plus One Set of Dilators | 86 | Standard Deviation 44 | hours | |
| Maximum Cervical Dilation | Two Sets of Dilators | Pre-op Cervical Dilation 2 cm | 2 | participants | |
| Maximum Cervical Dilation | Mifepristone Plus One Set of Dilators | Pre-op Cervical Dilation 2 cm | 3 | participants | |
| Maximum Cervical Dilation | Two Sets of Dilators | Pre-op Cervical Dilation 3 cm | 9 | participants | |
| Maximum Cervical Dilation | Mifepristone Plus One Set of Dilators | Pre-op Cervical Dilation 3 cm | 14 | participants | |
| Maximum Cervical Dilation | Two Sets of Dilators | Pre-Op Cervical Dilation 4 cm | 8 | participants | |
| Maximum Cervical Dilation | Mifepristone Plus One Set of Dilators | Pre-Op Cervical Dilation 4 cm | 5 | participants |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Two Sets of Dilators | 24 | |
| Overall Study | STARTED | Mifepristone Plus One Set of Dilators | 26 | |
| Overall Study | COMPLETED | Two Sets of Dilators | 21 | |
| Overall Study | COMPLETED | Mifepristone Plus One Set of Dilators | 24 | |
| Overall Study | NOT COMPLETED | Two Sets of Dilators | 3 | |
| Overall Study | NOT COMPLETED | Mifepristone Plus One Set of Dilators | 2 |
Source ClinicalTrials.gov
Adverse events6
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Pre-Procedure Delivery | Pregnancy, puerperium and perinatal conditions | Two Sets of Dilators | 2 | 24 | |
| other | Pre-Procedure Delivery | Pregnancy, puerperium and perinatal conditions | Mifepristone Plus One Set of Dilators | 1 | 26 | |
| other | Cervical Injury | Injury, poisoning and procedural complications | Two Sets of Dilators | 0 | 24 | |
| other | Cervical Injury | Injury, poisoning and procedural complications | Mifepristone Plus One Set of Dilators | 1 | 26 | |
| other | Rupture of Membranes with Subsequent Fever | Pregnancy, puerperium and perinatal conditions | Two Sets of Dilators | 1 | 24 | |
| other | Rupture of Membranes with Subsequent Fever | Pregnancy, puerperium and perinatal conditions | Mifepristone Plus One Set of Dilators | 0 | 26 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Two Sets of Dilators | ||
| Total, all-cause mortality | Mifepristone Plus One Set of Dilators | ||
| Total, other adverse events | Two Sets of Dilators | 3 | 24 |
| Total, other adverse events | Mifepristone Plus One Set of Dilators | 2 | 26 |
| Total, serious adverse events | Two Sets of Dilators | 0 | 24 |
| Total, serious adverse events | Mifepristone Plus One Set of Dilators | 0 | 26 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Two Sets of Dilators vs Mifepristone Plus One Set of Dilators: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01615731
GET https://conductscience.org/api/trials/v1/NCT01615731/results?page=2