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NCT01751087 · ClinicalTrials.gov registry record · NA
Cervical Preparation Before Dilation and Evacuation
A NA study, sponsored by Planned Parenthood League of Massachusetts.
- Completed
- Registry status
- NA
- Development phase
- 300
- Enrollment target
NCT01751087: Completed NA study, sponsored by Planned Parenthood League of Massachusetts.
NCT01751087 is a NA study that has completed, run by Planned Parenthood League of Massachusetts. The registered enrollment target is 300 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (79% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01751087, a NA study, has completed, sponsored by Planned Parenthood League of Massachusetts.
- COMPLETED
- Registry status
- NA
- Development phase
- 300 participants
- Enrollment target
Study Summary
The purpose of this research study is to compare three different ways of opening a woman's cervix before her second-trimester surgical abortion. * Osmotic dilators: small rods that, when inserted into the cervix, gently expand to open the cervix * Osmotic dilators plus mifepristone, a medicine that is swallowed * Osmotic dilators plus misoprostol, a medicine that is placed between the cheek and gum Hypotheses: * adding buccal misoprostol 3 hours preoperatively will significantly improve dilation compared to laminaria alone, making procedures faster, easier and safer. * adding oral mifepristone at the time of laminaria placement will confer a similar benefit. * the efficacy of adjunctive misoprostol and mifepristone will be influenced by gestational age, with women later in gestation having increased efficacy from these agents. * significantly more patients who receive adjunctive misoprostol or mifepristone will have adequate initial dilation, fewer will require manual dilation or additional cervical preparation and there will be fewer complications in these arms, although complication rates will be low and we will only be able to detect relatively large differences. * patients will prefer to have the procedure done as quickly as possible with as little discomfort as possible, that cervical ripening with adjunctive misoprostol will be associated with more cramping than osmotic dilators alone and that mifepristone will be well tolerated and may not cause more cramping or other side effects than osmotic dilators alone.
Primary Outcome
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
Interventions
- OTHER placebo
- DRUG misoprostol
- OTHER Mifepristone
- DEVICE Osmotic dilators
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 300 participants |
| Start Date | 2013-01 |
| Est. Completion | 2014-06 |
| Phase | NA |
What the finished NCT01751087 record still lists
NCT01751087 is an interventional study that assigns participants to a tested intervention. The registered 300 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (79% lower).
The record links to 0 conditions, and to 4 interventions - of which placebo is the first listed.
NCT01751087 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01751087 about?
NCT01751087 is a clinical study titled "Cervical Preparation Before Dilation and Evacuation". The purpose of this research study is to compare three different ways of opening a woman's cervix before her second-trimester surgical abortion. * Osmotic dilators: small rods that, when inserted into the cervix, gently expand to open the cervix * Osmotic dilators plus mifepristone, a medicine that...
What is the current status of trial NCT01751087?
This trial is currently completed. It is a NA study. The enrollment target is 300 participants. The study started on 2013-01. Estimated completion is 2014-06.
What interventions are being tested in trial NCT01751087?
The interventions under investigation include: placebo (OTHER), misoprostol (DRUG), Mifepristone (OTHER), Osmotic dilators (DEVICE).
Who is sponsoring clinical trial NCT01751087?
This trial is sponsored by Planned Parenthood League of Massachusetts, which has 13 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01751087's enrollment target sits among peer trials
300 330th of 2000 higher than 1,630 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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