Trial · NCT01751087
Cervical Preparation Before Dilation and Evacuation
NCT01751087, Not applicable, Completed, Planned Parenthood League of Massachusetts; results first posted 2016-02-24
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Cervical Preparation Before Dilation and Evacuation. Trials, record NCT01751087. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01751087
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Cervical Preparation Before Dilation and Evacuation
- NCT number
- NCT01751087
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 300 participants, actual
- Lead sponsor
- Planned Parenthood League of Massachusetts
- Conditions
- Abortion, Induced
- Interventions
- Mifepristone, misoprostol, Osmotic dilators, placebo, placebo
- First posted
- 2012-12-17
- Last updated
- 2016-02-24
- Results first posted
- 2016-02-24
- Limitations and caveats
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.
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Operative Time | participants were assessed for the duration of the procedure, an average of 6 minutes | 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 |
| Secondary | Initial Cervical Dilation | participants were assessed during cervical dilation process, average time of 1 minute | Measured at the time of procedure (immediately before the start of D\&E) |
| Secondary | Ability to Complete the D&E on the First Attempt | participants were assessed for the duration of the procedure, an average of 6 minutes | 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. |
| Secondary | Need for Mechanical Dilation | participants were assessed for the duration of the procedure, an average of 6 minutes | Assessed on Day of procedure. Assessed immediately after completion of D\&E |
| Secondary | Ease of Mechanical Dilation | participants were assessed for the duration of the procedure, an average of 6 minutes | 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 |
| Secondary | Complications From Procedure | assessed immediately after completion of D&E and at 1 week and 1 month post-procedure | Patient having any complication, including hospitalizations transfusions additional unplanned procedures |
| Secondary | Chills (Any) After Day 2 Medication Administration | assessed immediately after administration of day 2 medication | chills (any) after Day 2 medication administration |
| Secondary | Patient Satisfaction With Cervical Prep | patients' satisfaction with cervical prep was evaluated over course of cervical prep and procedure, up to 3 days | 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. |
| Secondary | Physician Satisfaction With Cervical Preparation | physicians' satisfaction with cervical prep was evaluated over course of procedure, an average of 6 minutes | 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. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Operative Time | participants were assessed for the duration of the procedure, an average of 6 minutes | 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\]. | minutes | MEAN |
| SECONDARY | Initial Cervical Dilation | participants were assessed during cervical dilation process, average time of 1 minute | 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. | centimeters | MEAN |
| SECONDARY | Ability to Complete the D&E on the First Attempt | participants were assessed for the duration of the procedure, an average of 6 minutes | participants | NUMBER | |
| SECONDARY | Need for Mechanical Dilation | participants were assessed for the duration of the procedure, an average of 6 minutes | Arm 1: one subject withdrawn/no intervention. Arm 2: one subject expelled, no D\&E. Arm 3: one subject withdrawn/no intervention | participants | NUMBER |
| SECONDARY | Ease of Mechanical Dilation | participants were assessed for the duration of the procedure, an average of 6 minutes | Number of participants in each arm who required additional mechanical dilation | participants | NUMBER |
| SECONDARY | Complications From Procedure | assessed immediately after completion of D&E and at 1 week and 1 month post-procedure | participants | NUMBER | |
| SECONDARY | Chills (Any) After Day 2 Medication Administration | assessed immediately after administration of day 2 medication | participants | NUMBER | |
| SECONDARY | Patient Satisfaction With Cervical Prep | patients' satisfaction with cervical prep was evaluated over course of cervical prep and procedure, up to 3 days | participants | NUMBER | |
| SECONDARY | Physician Satisfaction With Cervical Preparation | physicians' satisfaction with cervical prep was evaluated over course of procedure, an average of 6 minutes | 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. | participants | NUMBER |
Source ClinicalTrials.gov
Results by group27
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Operative Time | Osmotic Dilators + Placebo (Vit c) + Placebo (Vit B12) | 6.27 | Standard Deviation 3.5 | minutes | |
| Operative Time | Osmotic Dilators + Placebo (Vit c) + Misoprostol | 6.28 | Standard Deviation 4.6 | minutes | |
| Operative Time | Osmotic Dilators + Mifepristone + Placebo (Vit B12) | 5.53 | Standard Deviation 2.9 | minutes | |
| Initial Cervical Dilation | Osmotic Dilators + Placebo (Vit c) + Placebo (Vit B12) | 2.2 | Standard Deviation 0.5 | centimeters | |
| Initial Cervical Dilation | Osmotic Dilators + Placebo (Vit c) + Misoprostol | 2.5 | Standard Deviation 0.9 | centimeters | |
| Initial Cervical Dilation | Osmotic Dilators + Mifepristone + Placebo (Vit B12) | 2.4 | Standard Deviation 0.5 | centimeters | |
| Ability to Complete the D&E on the First Attempt | Osmotic Dilators + Placebo (Vit c) + Placebo (Vit B12) | 98 | participants | ||
| Ability to Complete the D&E on the First Attempt | Osmotic Dilators + Placebo (Vit c) + Misoprostol | 98 | participants | ||
| Ability to Complete the D&E on the First Attempt | Osmotic Dilators + Mifepristone + Placebo (Vit B12) | 98 | participants | ||
| Need for Mechanical Dilation | Osmotic Dilators + Placebo (Vit c) + Placebo (Vit B12) | 26 | 95% Confidence Interval 17.8 to 35.3 | participants |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Osmotic Dilators + Placebo (Vit c) + Placebo (Vit B12) | 100 | |
| Overall Study | STARTED | Osmotic Dilators + Placebo (Vit c) + Misoprostol | 100 | |
| Overall Study | STARTED | Osmotic Dilators + Mifepristone + Placebo (Vit B12) | 100 | |
| Overall Study | COMPLETED | Osmotic Dilators + Placebo (Vit c) + Placebo (Vit B12) | 99 | |
| Overall Study | COMPLETED | Osmotic Dilators + Placebo (Vit c) + Misoprostol | 100 | |
| Overall Study | COMPLETED | Osmotic Dilators + Mifepristone + Placebo (Vit B12) | 99 | |
| Overall Study | NOT COMPLETED | Osmotic Dilators + Placebo (Vit c) + Placebo (Vit B12) | 1 | |
| Overall Study | NOT COMPLETED | Osmotic Dilators + Placebo (Vit c) + Misoprostol | 0 | |
| Overall Study | NOT COMPLETED | Osmotic Dilators + Mifepristone + Placebo (Vit B12) | 1 |
Source ClinicalTrials.gov
Adverse events15
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 | uterine re-aspiration | Reproductive system and breast disorders | Osmotic Dilators + Placebo (Vit c) + Placebo (Vit B12) | 2 | 99 | 2 |
| other | uterine re-aspiration | Reproductive system and breast disorders | Osmotic Dilators + Placebo (Vit c) + Misoprostol | 1 | 100 | 1 |
| other | uterine re-aspiration | Reproductive system and breast disorders | Osmotic Dilators + Mifepristone + Placebo (Vit B12) | 1 | 99 | 1 |
| other | Intrauterine tamponade or cervical stay sutures | Reproductive system and breast disorders | Osmotic Dilators + Placebo (Vit c) + Placebo (Vit B12) | 3 | 99 | 3 |
| other | Intrauterine tamponade or cervical stay sutures | Reproductive system and breast disorders | Osmotic Dilators + Placebo (Vit c) + Misoprostol | 0 | 100 | 0 |
| other | Intrauterine tamponade or cervical stay sutures | Reproductive system and breast disorders | Osmotic Dilators + Mifepristone + Placebo (Vit B12) | 0 | 99 | 0 |
| other | cervical laceration requiring sutures | Reproductive system and breast disorders | Osmotic Dilators + Placebo (Vit c) + Placebo (Vit B12) | 3 | 99 | 3 |
| other | cervical laceration requiring sutures | Reproductive system and breast disorders | Osmotic Dilators + Placebo (Vit c) + Misoprostol | 0 | 100 | 0 |
| other | cervical laceration requiring sutures | Reproductive system and breast disorders | Osmotic Dilators + Mifepristone + Placebo (Vit B12) | 0 | 99 | 0 |
| serious | Hospitalization for bleeding | Reproductive system and breast disorders | Osmotic Dilators + Placebo (Vit c) + Placebo (Vit B12) | 2 | 99 | 2 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Osmotic Dilators + Placebo (Vit c) + Placebo (Vit B12) | ||
| Total, all-cause mortality | Osmotic Dilators + Placebo (Vit c) + Misoprostol | ||
| Total, all-cause mortality | Osmotic Dilators + Mifepristone + Placebo (Vit B12) | ||
| Total, other adverse events | Osmotic Dilators + Placebo (Vit c) + Placebo (Vit B12) | 8 | 99 |
| Total, other adverse events | Osmotic Dilators + Placebo (Vit c) + Misoprostol | 1 | 100 |
| Total, other adverse events | Osmotic Dilators + Mifepristone + Placebo (Vit B12) | 1 | 99 |
| Total, serious adverse events | Osmotic Dilators + Placebo (Vit c) + Placebo (Vit B12) | 2 | 99 |
| Total, serious adverse events | Osmotic Dilators + Placebo (Vit c) + Misoprostol | 1 | 100 |
| Total, serious adverse events | Osmotic Dilators + Mifepristone + Placebo (Vit B12) | 1 | 99 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 26196084 | DERIVED |
Source PubMed
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT01751087
GET https://conductscience.org/api/trials/v1/NCT01751087/results?page=2