NCT02841072

Brief Summary

The primary objective of this study is to document the rates of success and serious complications among women having outpatient medical abortions with 200 mg mifepristone + 800 buccal misoprostol at 64-70 days of gestation.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
579

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2015

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2015

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 15, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 21, 2016

Completed
Last Updated

July 21, 2016

Status Verified

July 1, 2016

Enrollment Period

11 months

First QC Date

July 15, 2016

Last Update Submit

July 20, 2016

Conditions

Abortion, Medical

Outcome Measures

Primary Outcomes (2)

  • Abortion Success

    Defined as a complete abortion without use of surgery

    1 week

  • Serious complications

    Defined as admission to hospital, receipt of parenteral antibiotics, surgery (laparoscopies, laparotomies, hysterectomies), transfusion, or death

    1 month

Secondary Outcomes (3)

  • Proportion of ongoing pregnancies

    1 week

  • Proportion of complete abortions without additional treatment

    1 week

  • Proportion of significant abortion complications

    1 month

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study will be conducted at US abortion clinics that have offered medical abortion with 200 mg mifepristone + 800 mcg buccal misoprostol to at least 20 women at 64-70 days of gestation. Designated staff at each site will review clinic records to identify and record data from every patient treated in that gestational week.

You may qualify if:

  • Women at 64-70 days of gestation
  • Received 200 mg mifepristone + 800 mcg buccal misoprostol for a medical abortion

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Family Planning Associates- Northwest Chicago

Chicago, Illinois, 60630, United States

Location

Family Planning Associates- Downtown Chicago

Chicago, Illinois, 60661, United States

Location

Study Officials

  • Elizabeth Raymond, MD, MPH

    Gynuity Health Projects

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 15, 2016

First Posted

July 21, 2016

Study Start

May 1, 2015

Primary Completion

April 1, 2016

Study Completion

April 1, 2016

Last Updated

July 21, 2016

Record last verified: 2016-07

Locations

US(2)