Cervical Preparation Before Dilation and Evacuation
Completed · Not applicable · Has a placebo group
Conditions studied: Abortion, Induced
In brief
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.
Key facts
- Study ID
- NCT01751087
- Run by
- Planned Parenthood League of Massachusetts
- People needed
- 300
- Starts
- 2013-01-01
- Expected to finish
- 2014-06-01
- Last updated by the study team
- 2016-02-24
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- 18 years and older
- Able to give informed consent
- Medically eligible for outpatient second trimester pregnancy termination at the clinical site
- English-speaking or Spanish-speaking at sites with ability to obtain informed consent in Spanish
You may not qualify if…
- Active bleeding (>1 pad/hour) or hemodynamically unstable at enrollment
- Signs of chorioamnionitis or clinical infection at enrollment
- Signs of spontaneous labor or cervical insufficiency at enrollment
- Spontaneous intrauterine fetal demise
- Patient incarcerated
- Allergy to mifepristone or misoprostol
- Chronic steroid use or adrenal insufficiency
- Porphyria
- Inflammatory bowel disease requiring treatment
Where it is running
- San Francisco General Hospital — San Francisco, California, United States
- Family Planning Associates — Chicago, Illinois, United States
- Brigham and Women's Hospital — Boston, Massachusetts, United States
- Boston Medical Center — Boston, Massachusetts, United States
- Planned Parenthood of New York City — New York, New York, United States
- Lovejoy Surgical Center — Portland, Oregon, United States
- Magee Women's Hospital — Pittsburgh, Pennsylvania, United States
Full record on ClinicalTrials.gov
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