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Misoprostol Dose and Timing Before Surgical Abortion at 13 to 16 Weeks' Gestation: a Randomized Trial

Abortion, Induced Clinical Trial

Official title:
Misoprostol Dose and Timing Before Surgical Abortion at 13 to 16 Weeks' Gestation: a Randomized Trial

Clinical Trial Summary

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

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02279914
Study type Interventional
Source Planned Parenthood of Greater New York
Contact
Status Completed
Phase N/A
Start date November 2014
Completion date August 2016
View Details
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