An interventional study of Misoprostol 400 mcg 3 hours prior to procedure and Misoprostol 600 mcg 90 minutes prior to procedure in Abortion, Induced, sponsored by Planned Parenthood of Greater New York. Completed at 1 site in United States. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-04-26.
Sponsored by Planned Parenthood of Greater New York · Not applicable, Interventional, and Treatment
This study is a blinded randomized trial to compare two different doses and intervals of buccal misoprostol for cervical preparation before surgical abortion at 13 to 16 weeks' gestation: 400 mcg administered 3 hours before D\&E (dilation and extraction), and 600 mcg administered 1.5 hours before D\&E.
Primary objective: To compare operative times after two different doses and intervals of misoprostol using a non-inferiority design.
Secondary objectives: To compare the doses and intervals of misoprostol for differences in: (1) initial cervical dilation; (2) need for mechanical dilation and ease of dilation if required; (3) ability to complete the abortion procedure without further cervical preparation; (4) complications; (5) provider variables including ease of procedure and satisfaction with cervical preparation; (6) patient variables including pre-operative side effects, post-operative pain, and acceptability
The investigators compared two doses and intervals of buccal misoprostol for cervical preparation before surgical abortion at 13 to 16 weeks' gestation. This blinded randomized trial compared 400 mcg misoprostol administered 3 hours and 600 mcg administered 1.5 hours before abortion. The investigators analyzed results for the primary outcome (procedure time) using a non-inferiority limit of 3 or more minutes. The investigators tested two separate non-inferiority hypotheses each powered at 95% (2.5% confidence interval) for two gestational age groups: 13.0-14.3 and 14.4-15.6 weeks. Assuming 10% withdrawals, the investigators required 118 participants. Secondary outcomes included mechanical dilation, complications, provider satisfaction, and patient side effects and acceptability.
Planned Parenthood of Greater New York is the lead sponsor of 6 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
receives 400 mcg of misoprostol 3 hours prior to the procedure
Drug: Misoprostol 400 mcg 3 hours prior to procedure
receives 600 mcg of misoprostol 90 minutes prior to the procedure
Drug: Misoprostol 600 mcg 90 minutes prior to procedure
Misoprostol 400 mcg 3 hours prior to D\&E procedure
Misoprostol 600 mcg 90 minutes prior to D\&E procedure
procedure time
Operative time defined as time from speculum in vagina to speculum out of vagina.
Time frame: day of abortion procedure
This study is completed, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.
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Planned Parenthood of Greater New York