NCT02381223

Brief Summary

This study aims to collection additional data on the safety and acceptability of medical abortion without pretreatment pelvic ultrasound or exam in woman who meet certain criteria.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
409

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2015

Geographic Reach
3 countries

5 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

First Submitted

Initial submission to the registry

February 23, 2015

Completed
6 days until next milestone

Study Start

First participant enrolled

March 1, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 6, 2015

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

May 1, 2017

Status Verified

April 1, 2017

Enrollment Period

1.8 years

First QC Date

February 23, 2015

Last Update Submit

April 28, 2017

Conditions

Medical; Abortion, Fetus

Outcome Measures

Primary Outcomes (1)

  • Incidence of serious adverse events

    7 days

Eligibility Criteria

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

Female: only female participants are being studied

You may qualify if:

  • Women having medical abortion

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Carafem

Friendship Heights, Maryland, 20815, United States

Location

Planned Parenthood Minnesota, North Dakota, South Dakora

Minneapolis, Minnesota, 55114, United States

Location

Institute for Family Health

New York, New York, 10003, United States

Location

Centro de Salud Mexico-Espana

Mexico City, Mexico

Location

Reproductive Health Training Center

Chisinau, Moldova

Location

Related Publications (1)

  • Raymond EG, Tan YL, Comendant R, Sagaidac I, Hodorogea S, Grant M, Sanhueza P, Van Pratt E, Gillespie G, Boraas C, Weaver MA, Platais I, Bousieguez M, Winikoff B. Simplified medical abortion screening: a demonstration project. Contraception. 2018 Apr;97(4):292-296. doi: 10.1016/j.contraception.2017.11.005. Epub 2017 Nov 21.

    PMID: 29170088DERIVED

Study Officials

  • Elizabeth Raymond, MD

    Gynuity Health Projects

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 23, 2015

First Posted

March 6, 2015

Study Start

March 1, 2015

Primary Completion

January 1, 2017

Study Completion

January 1, 2017

Last Updated

May 1, 2017

Record last verified: 2017-04

Locations

US(3)ME(1)MO(1)