Misoprostol Dose and Timing Before Surgical Abortion at 13 to 16 Weeks' Gestation: a Randomized Trial
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | November 2014 |
| End Date: | June 2016 |
| Contact: | Principal Investigator, MD, MPH |
| Email: | cti@ppnyc.org |
| Phone: | 212-274-7324 |
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
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
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
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