NCT02633631

Brief Summary

The Contraceptive Choice Center will use an innovative-model of contraceptive care which was developed as a part of the Contraceptive CHOICE Project (CHOICE). This delivery model will deliver high-quality family planning services for women and reduce unintended pregnancies and births. This intervention will result in improved health for women, improved health care, and reduced costs to Medicaid. The Center will provide care to women ages 14-45 years of age.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,664

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 22, 2015

Completed
8 months until next milestone

First Posted

Study publicly available on registry

December 17, 2015

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2020

Completed
Last Updated

June 3, 2021

Status Verified

June 1, 2021

Enrollment Period

5.3 years

First QC Date

April 22, 2015

Last Update Submit

June 1, 2021

Conditions

Unintended PregnancyContraceptionFamily Planning

Outcome Measures

Primary Outcomes (1)

  • Rate of unintended pregnancy

    Reduce unintended pregnancy by 10% - # of pregnancies that are unintended per 1000 reproductive-age women (14-45 years)

    24 months

Secondary Outcomes (1)

  • Rate of unintended births

    24 months

Study Arms (1)

Women seeking family planning services

Women seeking family planning and gynecological services will be enrolled in our study.

Eligibility Criteria

Age14 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

We plan to recruit women who are at high risk for unintended pregnancy and birth.

You may qualify if:

  • Childbearing-age seeking family planning services
  • Negative pregnancy test
  • Willing and able to undergo informed consent

You may not qualify if:

  • Current participation in a research study that would interfere with the conduct of this study
  • Currently pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Division of Clinical Research at Washington University

St Louis, Missouri, 63108, United States

Location

Study Officials

  • Tessa Madden, MD,MPH

    Washington University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

April 22, 2015

First Posted

December 17, 2015

Study Start

January 1, 2015

Primary Completion

April 1, 2020

Study Completion

April 1, 2020

Last Updated

June 3, 2021

Record last verified: 2021-06

Locations

US(1)