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

• Status: Completed
• Trial end date: 2016-08-01
• Target enrollment: 0
• Participant gender: Female

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

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Planned Parenthood of Greater New York; Planned Parenthood of New York City, Inc.
• Treatments: Misoprostol

Criteria

Inclusion Criteria:

• 18 years of age and older

• Eligible for pregnancy termination at Planned Parenthood of NYC

• Able to give informed consent

• English speaking

Exclusion Criteria:

• Reports active bleeding, severe pain, or symptoms of spontaneous labor at enrollment

• Intrauterine fetal demise identified on pre-operative ultrasound

• Allergy to misoprostol