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

Completed · Not applicable

Conditions studied: Abortion, Induced

In brief

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

Key facts

Study ID: NCT02279914
Run by: Planned Parenthood of Greater New York
People needed: 118
Starts: 2014-11-01
Expected to finish: 2016-08-01
Last updated by the study team: 2021-04-26

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: accepted.

You may qualify if…

18 years of age and older
Eligible for pregnancy termination at Planned Parenthood of NYC
Able to give informed consent
English speaking

You may not qualify if…

Reports active bleeding, severe pain, or symptoms of spontaneous labor at enrollment
Intrauterine fetal demise identified on pre-operative ultrasound
Allergy to misoprostol

Where it is running

Planned Parenthood of New York City - Margaret Sanger Center — New York, New York, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.