Contraceptive Choice Center | NCT02633631

Studies
Contraceptive Choice Center

NCT02633631

Sponsor

Washington University School of Medicine

Status

Completed

Last Update Posted

Jun 3, 2021Actual

Enrollment

2,664Actual

Phase

Not provided

Conditions

Unintended Pregnancy
Contraception
Family Planning

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 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

Jan 2015Actual

Primary Completion Date

Apr 2020Actual

Completion Date

Apr 2020Actual

First Submitted Date

Apr 22, 2015

First Submission Date that Met QC Criteria

Dec 14, 2015

First Posted Date

Dec 17, 2015Estimated

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

Jun 1, 2021

Last Update Posted Date

Jun 3, 2021Actual

Name	Class
Centers for Medicare and Medicaid Services	FED

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

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.

Detailed Description

The Center will provide high-quality contraceptive care using the innovative model of the Contraceptive CHOICE Project. Specifically, the model will provide the following components: 1) Structured, evidence-based contraceptive counseling; 2) education of providers about long-acting reversible contraceptive (LARC) methods and evidence-based guidelines for contraceptive provision; 3) removal of patient barriers to family planning services; and 4) post-visit contraceptive support. The model addresses the barriers to contraceptive uptake.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

2,664Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Women seeking family planning services		Women seeking family planning and gynecological services will be enrolled in our study.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Rate of unintended births	Reduce unintended births and associated costs by 15% - # of births that are unintended per 1000 reproductive age women	24 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

14 Years

Maximum Age

45 Years

Standard Ages

ChildAdult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Tessa Madden, MD,MPH	Washington University School of Medicine	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Division of Clinical Research at Washington University		St Louis	Missouri	63108	United States