Trial · NCT00835731
Misoprostol Versus Dilapan-S for Cervical Preparation
NCT00835731, Not applicable, Completed, Planned Parenthood League of Massachusetts; results first posted 2014-01-07
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Misoprostol Versus Dilapan-S for Cervical Preparation. Trials, record NCT00835731. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00835731
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Misoprostol Versus Dilapan-S for Cervical Preparation
- NCT number
- NCT00835731
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 125 participants, actual
- Lead sponsor
- Planned Parenthood League of Massachusetts
- Conditions
- Cervical Ripening
- Interventions
- misoprostol, Dilapan-S, vitamin B-12
- First posted
- 2009-02-04
- Last updated
- 2017-10-23
- Results first posted
- 2014-01-07
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Cervical Dilation in Women Following Exposure to Either Ripening Agent | 3-4 hours after placement of ripening agent | |
| Secondary | Ease of Further Mechanical Dilation in Women Following Exposure to Either Ripening Agent, as Per MD Report | 3-4 hours after placement of ripening agent | 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) |
| Secondary | Procedure Time for Dilation and Evacuation | 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 | 3-4 hours after placement of ripening agent | |
| Secondary | Subject Pain During Ripening | 3-4 hours after placement of ripening agent | 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. |
| Secondary | Subject Pain During Dilation and Evacuation | 3-4 hours after placement of ripening agent | 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. |
| Secondary | Women's Satisfaction With Cervical Ripening Method | 5 hours after placement of ripening agent | Scale: 1 = very dissatisfied, 2 = dissatisfied, 3 = neutral, 4 = satisfied, 5 = very satisfied |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Cervical Dilation in Women Following Exposure to Either Ripening Agent | 3-4 hours after placement of ripening agent | mm | MEAN | |
| SECONDARY | Ease of Further Mechanical Dilation in Women Following Exposure to Either Ripening Agent, as Per MD Report | 3-4 hours after placement of ripening agent | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Procedure Time for Dilation and Evacuation | 3-4 hours after placement of ripening agent | minutes | MEDIAN | |
| SECONDARY | 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 | participants | NUMBER | |
| SECONDARY | Subject Pain During Ripening | 3-4 hours after placement of ripening agent | Scores on a scale | MEDIAN | |
| SECONDARY | Subject Pain During Dilation and Evacuation | 3-4 hours after placement of ripening agent | Scores on a scale | MEDIAN | |
| SECONDARY | Women's Satisfaction With Cervical Ripening Method | 5 hours after placement of ripening agent | units on a scale | MEDIAN |
Source ClinicalTrials.gov
Results by group20
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Cervical Dilation in Women Following Exposure to Either Ripening Agent | Misoprostol | 32.1 | Standard Deviation 6.0 | mm | |
| Cervical Dilation in Women Following Exposure to Either Ripening Agent | Synthetic Osmotic Dilator | 33.9 | Standard Deviation 4.7 | mm | |
| Ease of Further Mechanical Dilation in Women Following Exposure to Either Ripening Agent, as Per MD Report | Misoprostol | None needed (score of 0) | 3 | Participants | |
| Ease of Further Mechanical Dilation in Women Following Exposure to Either Ripening Agent, as Per MD Report | Synthetic Osmotic Dilator | None needed (score of 0) | 3 | Participants | |
| Ease of Further Mechanical Dilation in Women Following Exposure to Either Ripening Agent, as Per MD Report | Misoprostol | Very-somewhat easy (score of 1-2) | 29 | Participants | |
| Ease of Further Mechanical Dilation in Women Following Exposure to Either Ripening Agent, as Per MD Report | Synthetic Osmotic Dilator | Very-somewhat easy (score of 1-2) | 27 | Participants | |
| Ease of Further Mechanical Dilation in Women Following Exposure to Either Ripening Agent, as Per MD Report | Misoprostol | Moderate (score of 3) | 12 | Participants | |
| Ease of Further Mechanical Dilation in Women Following Exposure to Either Ripening Agent, as Per MD Report | Synthetic Osmotic Dilator | Moderate (score of 3) | 24 | Participants | |
| Ease of Further Mechanical Dilation in Women Following Exposure to Either Ripening Agent, as Per MD Report | Misoprostol | Somewhat-very difficult (score of 4-5) | 18 | Participants | |
| Ease of Further Mechanical Dilation in Women Following Exposure to Either Ripening Agent, as Per MD Report | Synthetic Osmotic Dilator | Somewhat-very difficult (score of 4-5) | 6 | Participants |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Misoprostol | 64 | |
| Overall Study | STARTED | Synthetic Osmotic Dilator | 61 | |
| Overall Study | COMPLETED | Misoprostol | 62 | |
| Overall Study | COMPLETED | Synthetic Osmotic Dilator | 60 | |
| Overall Study | NOT COMPLETED | Misoprostol | 2 | |
| Overall Study | NOT COMPLETED | Synthetic Osmotic Dilator | 1 |
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 | Same-day re-evacuation | Reproductive system and breast disorders | Misoprostol | 2 | 62 | 2 |
| other | Same-day re-evacuation | Reproductive system and breast disorders | Synthetic Osmotic Dilator | 2 | 60 | 2 |
| other | Hemorrhage | Reproductive system and breast disorders | Misoprostol | 0 | 62 | 0 |
| other | Hemorrhage | Reproductive system and breast disorders | Synthetic Osmotic Dilator | 1 | 60 | 1 |
| other | Cervical laceration | Reproductive system and breast disorders | Misoprostol | 1 | 62 | 1 |
| other | Cervical laceration | Reproductive system and breast disorders | Synthetic Osmotic Dilator | 0 | 60 | 0 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Misoprostol | ||
| Total, all-cause mortality | Synthetic Osmotic Dilator | ||
| Total, other adverse events | Misoprostol | 3 | 62 |
| Total, other adverse events | Synthetic Osmotic Dilator | 3 | 60 |
| Total, serious adverse events | Misoprostol | 0 | 62 |
| Total, serious adverse events | Synthetic Osmotic Dilator | 0 | 60 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Misoprostol vs Synthetic Osmotic Dilator: Number of Patients for Whom Physician Was Able to Complete Dilation and Evacuation Procedure on First Attempt | Trial comparisons |
| Misoprostol vs Synthetic Osmotic Dilator: serious adverse events | 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/NCT00835731
GET https://conductscience.org/api/trials/v1/NCT00835731/registered