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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
300
oral mifepristone 200 mg on Day 1.
buccal misoprostol 400 mcg on Day 2
osmotic dilators on Day 1
placebo for mifepristone, on day 1
placebo for misoprostol, on day 2
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
Operative Time
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
Time frame: participants were assessed for the duration of the procedure, an average of 6 minutes
Initial Cervical Dilation
Measured at the time of procedure (immediately before the start of D\&E)
Time frame: participants were assessed during cervical dilation process, average time of 1 minute
Ability to Complete the D&E on the First Attempt
Assessed on day of procedure and following day. If the procedure was unable to be completed as planned and the subject had to leave the procedure room and return for another attempt either at a time later the same day or the next day.
Time frame: participants were assessed for the duration of the procedure, an average of 6 minutes
Need for Mechanical Dilation
Assessed on Day of procedure. Assessed immediately after completion of D\&E
Time frame: participants were assessed for the duration of the procedure, an average of 6 minutes
Ease of Mechanical Dilation
Number of participants for whom, if additional mechanical dilation was required, it was difficult or very difficult. Assessed on day of procedure. Assessed after completion of D\&E
Time frame: participants were assessed for the duration of the procedure, an average of 6 minutes
Complications From Procedure
Patient having any complication, including hospitalizations transfusions additional unplanned procedures
Time frame: assessed immediately after completion of D&E and at 1 week and 1 month post-procedure
Chills (Any) After Day 2 Medication Administration
chills (any) after Day 2 medication administration
Time frame: assessed immediately after administration of day 2 medication
Patient Satisfaction With Cervical Prep
Patients who were very satisfied or satisfied with cervical preparation. Assessed on Day of procedure. Assessed after completion of D\&E procedure and just prior to discharge home.
Time frame: patients' satisfaction with cervical prep was evaluated over course of cervical prep and procedure, up to 3 days
Physician Satisfaction With Cervical Preparation
Participants for whom the operating physician reported being satisfied or very satisfied with the cervical preparation. Assessed on Day of procedure. Assessed after completion of D\&E procedure.
Time frame: physicians' satisfaction with cervical prep was evaluated over course of procedure, an average of 6 minutes
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