Study Results
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View full resultsBasic Information
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COMPLETED
NA
300 participants
INTERVENTIONAL
2013-01-31
2014-06-30
Brief Summary
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* 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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Osmotic dilators + placebo (vit c) + placebo (vit B12)
Women will receive osmotic dilators on Day 1, oral placebo on Day 1, and buccal placebo on Day 2.
Osmotic dilators
osmotic dilators on Day 1
placebo
placebo for mifepristone, on day 1
placebo
placebo for misoprostol, on day 2
Osmotic dilators + placebo (vit c) + misoprostol
Women will receive osmotic dilators on Day 1, oral placebo on Day 1, and buccal misoprostol 400 mcg on Day 2.
misoprostol
buccal misoprostol 400 mcg on Day 2
Osmotic dilators
osmotic dilators on Day 1
placebo
placebo for mifepristone, on day 1
Osmotic dilators + mifepristone + placebo (vit B12)
Women will receive osmotic dilators on Day 1, oral mifepristone 200 mg on Day 1, and buccal placebo on Day 2.
Mifepristone
oral mifepristone 200 mg on Day 1.
Osmotic dilators
osmotic dilators on Day 1
placebo
placebo for misoprostol, on day 2
Interventions
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Mifepristone
oral mifepristone 200 mg on Day 1.
misoprostol
buccal misoprostol 400 mcg on Day 2
Osmotic dilators
osmotic dilators on Day 1
placebo
placebo for mifepristone, on day 1
placebo
placebo for misoprostol, on day 2
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
FEMALE
Yes
Sponsors
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Society of Family Planning
OTHER
Planned Parenthood League of Massachusetts
OTHER
Responsible Party
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Principal Investigators
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Principal Investigator, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
Planned Parenthood League of Massachusetts
Locations
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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
Countries
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References
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Goldberg AB, Fortin JA, Drey EA, Dean G, Lichtenberg ES, Bednarek PH, Chen BA, Dutton C, McKetta S, Maurer R, Winikoff B, Fitzmaurice GM. Cervical Preparation Before Dilation and Evacuation Using Adjunctive Misoprostol or Mifepristone Compared With Overnight Osmotic Dilators Alone: A Randomized Controlled Trial. Obstet Gynecol. 2015 Sep;126(3):599-609. doi: 10.1097/AOG.0000000000000977.
Other Identifiers
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SFPRF6-MS
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
9-500-25.1
Identifier Type: -
Identifier Source: org_study_id
NCT01799928
Identifier Type: -
Identifier Source: nct_alias
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