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

Sponsor

Planned Parenthood of Greater New York (Other)

Overall Status

Completed

CT.gov ID

NCT02279914

Collaborator

(none)

118

Enrollment

Location

Arms

Duration (Months)

5.6

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Abortion, Induced	Drug: Misoprostol 400 mcg 3 hours prior to procedure Drug: Misoprostol 600 mcg 90 minutes prior to procedure	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

118 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Care Provider)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Nov 1, 2014

Actual Primary Completion Date :

Aug 1, 2016

Actual Study Completion Date :

Aug 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 400 mcg receives 400 mcg of misoprostol 3 hours prior to the procedure	Drug: Misoprostol 400 mcg 3 hours prior to procedure Misoprostol 400 mcg 3 hours prior to D&E procedure
Experimental: 600 mcg receives 600 mcg of misoprostol 90 minutes prior to the procedure	Drug: Misoprostol 600 mcg 90 minutes prior to procedure Misoprostol 600 mcg 90 minutes prior to D&E procedure

Arm

Intervention/Treatment

Experimental: 400 mcg

receives 400 mcg of misoprostol 3 hours prior to the procedure

Drug: Misoprostol 400 mcg 3 hours prior to procedure

Misoprostol 400 mcg 3 hours prior to D&E procedure

Experimental: 600 mcg

receives 600 mcg of misoprostol 90 minutes prior to the procedure

Drug: Misoprostol 600 mcg 90 minutes prior to procedure

Misoprostol 600 mcg 90 minutes prior to D&E procedure

Outcome Measures

Primary Outcome Measures

procedure time [day of abortion procedure]
Operative time defined as time from speculum in vagina to speculum out of vagina.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Planned Parenthood of New York City - Margaret Sanger Center	New York	New York	United States	10012

Sponsors and Collaborators

Planned Parenthood of Greater New York

Investigators

Principal Investigator: Gillian Dean, MD, MPH, Planned Parenthood of NYC

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Planned Parenthood of Greater New York

ClinicalTrials.gov Identifier:

NCT02279914

Other Study ID Numbers:

Miso

First Posted:

Oct 31, 2014

Last Update Posted:

Apr 26, 2021

Last Verified:

Apr 1, 2021

Additional relevant MeSH terms:

Misoprostol

Study Results

No Results Posted as of Apr 26, 2021