Abortion, Induced Clinical Trial
Official title:
Cervical Preparation Before Dilation and Evacuation in the Second Trimester: A Multicenter Randomized Trial Comparing Osmotic Dilators Alone to Dilators Plus Adjunctive Misoprostol or Adjunctive Mifepristone.
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.
n/a
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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