Misoprostol Dose and Timing Before Surgical Abortion at 1... | NCT02279914

Status Module

Record Verification Date

Apr 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2014

Primary Completion Date

Aug 2016Actual

Completion Date

Aug 2016Actual

First Submitted Date

Oct 29, 2014

First Submission Date that Met QC Criteria

Oct 29, 2014

First Posted Date

Oct 31, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 21, 2021

Last Update Posted Date

Apr 26, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sponsor

Lead Sponsor

Planned Parenthood of Greater New YorkOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

118Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
400 mcg	Experimental	receives 400 mcg of misoprostol 3 hours prior to the procedure	Drug: Misoprostol 400 mcg 3 hours prior to procedure
600 mcg	Experimental	receives 600 mcg of misoprostol 90 minutes prior to the procedure	Drug: Misoprostol 600 mcg 90 minutes prior to procedure

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Misoprostol 400 mcg 3 hours prior to procedure	Drug	Misoprostol 400 mcg 3 hours prior to D&E procedure	400 mcg

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
procedure time	Operative time defined as time from speculum in vagina to speculum out of vagina.	day of abortion procedure

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Gillian Dean, MD, MPH	Planned Parenthood of NYC	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Planned Parenthood of New York City - Margaret Sanger Center		New York	New York	10012	United States

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

No data available

No data is available for this block.

Intervention Browse Module

MeSH Terms

ID	Term
D016595	Misoprostol

Ancestor Terms

ID	Term
D011459	Prostaglandins E, Synthetic
D011465	Prostaglandins, Synthetic
D011453	Prostaglandins
D015777	Eicosanoids
D005231	Fatty Acids, Unsaturated
D005227	Fatty Acids
D008055	Lipids
D012898	Autacoids
D018836	Inflammation Mediators
D001685	Biological Factors