Mifepristone
Otheroral mifepristone 200 mg on Day 1.
Other names: Mifeprex
NCT Number: NCT01751087
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.
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Notify Me18 year and older
Female
Interventional
Not applicable
San Francisco General Hospital, San Francisco, California, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
oral mifepristone 200 mg on Day 1.
Other names: Mifeprex
buccal misoprostol 400 mcg on Day 2
Other names: Cytotec
osmotic dilators on Day 1
Other names: laminaria, Dilapan-S
placebo for mifepristone, on day 1
Other names: vitamin C 500 mg
Time frame: participants were assessed for the duration of the procedure, an average of 6 minutes
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 during cervical dilation process, average time of 1 minute
Measured at the time of procedure (immediately before the start of D&E)
Time frame: participants were assessed for the duration of the procedure, an average of 6 minutes
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
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
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: assessed immediately after completion of D&E and at 1 week and 1 month post-procedure
Patient having any complication, including hospitalizations transfusions additional unplanned procedures
Time frame: assessed immediately after administration of day 2 medication
chills (any) after Day 2 medication administration
Time frame: patients' satisfaction with cervical prep was evaluated over course of cervical prep and procedure, up to 3 days
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: physicians' satisfaction with cervical prep was evaluated over course of procedure, an average of 6 minutes
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.
Planned Parenthood League of Massachusetts
Other
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.
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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