NCT02279914

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 118 (actual)
• Sponsor: Planned Parenthood of Greater New York · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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

Detailed 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.

Conditions

• Abortion, Induced

Interventions

Type	Name	Description
DRUG	Misoprostol 400 mcg 3 hours prior to procedure	Misoprostol 400 mcg 3 hours prior to D\&E procedure
DRUG	Misoprostol 600 mcg 90 minutes prior to procedure	Misoprostol 600 mcg 90 minutes prior to D\&E procedure

Timeline

• Start date: 2014-11-01
• Primary completion: 2016-08-01
• Completion: 2016-08-01
• First posted: 2014-10-31
• Last updated: 2021-04-26

Locations

1 site across 1 country: United States