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 Details — Status: Completed

Administrative data

• NCT number: NCT02279914
• Other study ID #: Miso
• Status: Completed
• Phase: N/A
• Start date: November 2014
• Est. completion date: August 2016

Study information

• Verified date: April 2021
• Source: Planned Parenthood of Greater New York
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 118
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Abortion, Induced

Intervention

Drug:
• Misoprostol 400 mcg 3 hours prior to procedure
Misoprostol 400 mcg 3 hours prior to D&E procedure
• Misoprostol 600 mcg 90 minutes prior to procedure
Misoprostol 600 mcg 90 minutes prior to D&E procedure

Locations

Country	Name	City	State
United States	Planned Parenthood of New York City - Margaret Sanger Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Planned Parenthood of Greater New York

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	procedure time	Operative time defined as time from speculum in vagina to speculum out of vagina.	day of abortion procedure