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

NCT ID: NCT02279914

Last Updated: 2021-04-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 118 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-11-30
• Study Completion Date: 2016-08-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

400 mcg

receives 400 mcg of misoprostol 3 hours prior to the procedure

Group Type: EXPERIMENTAL

Misoprostol 400 mcg 3 hours prior to procedure

Intervention Type: DRUG

Misoprostol 400 mcg 3 hours prior to D\&E procedure

600 mcg

receives 600 mcg of misoprostol 90 minutes prior to the procedure

Group Type: EXPERIMENTAL

Misoprostol 600 mcg 90 minutes prior to procedure

Intervention Type: DRUG

Misoprostol 600 mcg 90 minutes prior to D\&E procedure

Interventions

Misoprostol 400 mcg 3 hours prior to procedure

Misoprostol 400 mcg 3 hours prior to D\&E procedure

Intervention Type: DRUG

Misoprostol 600 mcg 90 minutes prior to procedure

Misoprostol 600 mcg 90 minutes prior to D\&E procedure

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Planned Parenthood of Greater New York

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gillian Dean, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Planned Parenthood of NYC

Locations

Planned Parenthood of New York City - Margaret Sanger Center

New York, New York, United States

Countries

United States

Other Identifiers

Miso

Identifier Type: -

Identifier Source: org_study_id