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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 is a NA study that has completed, run by Planned Parenthood League of Massachusetts. The registered enrollment target is 300 participants.

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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.

Interventions

  • OTHER placebo
  • DRUG misoprostol
  • OTHER Mifepristone
  • DEVICE Osmotic dilators

Trial Details

FieldValue
Enrollment Target 300 participants
Start Date 2013-01
Est. Completion 2014-06
Phase NA

What the Registry Record Tells You About NCT01751087

The ClinicalTrials.gov registry entry for NCT01751087 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 300 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Planned Parenthood League of Massachusetts, which has 13 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 4 interventions - of which placebo is the first listed.

NCT01751087 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.