Michigan Contraceptive Access, Research, and Evaluation Study Children: Phase 1 (M-CARES-K)

May 30, 2026 updated by: Martha Bailey, University of Michigan

The Effects of Unintended Pregnancy on Children

This project builds on the Michigan Contraceptive Access Research and Evaluation Study (M-CARES) to evaluate the long-term effects of mothers' access to free contraceptives and reductions in unintended pregnancies on their children's well-being.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

M-CARES uses a randomized control trial design to assess the effects of providing free contraception to mothers on their children born before the intervention. The population subject to intervention is fecund women age 18-35 years at risk of pregnancy and who are clients at Planned Parenthood clinics of Michigan (PPMI), who meet income eligibility criteria, and who would otherwise pay out-of-pocket for services on the day of recruitment (i.e., lacking insurance coverage for received service). The experimental (treatment) condition is a mother's receipt of a voucher providing access to no-cost contraception (up to the price of a name-brand intrauterine device) for 100 days. The control group of mothers receives no voucher. All enrolled women complete a two-part baseline survey and consent to be re-contacted for two follow-up interviews in outgoing years. They also complete a two-part baseline survey and consent to be re-contacted for two follow up interviews in outgoing years. In addition, mothers consent to linkages to their own and their children's administrative data from records held by state and federal health, education, criminal justice, and tax records. Consent covers children already born to women at the time of intervention and children born after intervention. Survey and administrative data provide outcome measures to assess children's well-being and development up to age 18. The study will compare children of mothers who receive the intervention to those who did not.

Study Type

Interventional

Enrollment (Estimated)

4700

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48103
        • Recruiting
        • Planned Parenthood - Ann Arbor-West
        • Contact:
      • Detroit, Michigan, United States, 48201
        • Recruiting
        • Planned Parenthood - Detroit
        • Contact:
      • Ferndale, Michigan, United States, 48220
        • Recruiting
        • Planned Parenthood - Ferndale
        • Contact:
      • Grand Rapids, Michigan, United States, 49503
        • Recruiting
        • Planned Parenthood - Grand Rapids
        • Contact:
      • Kalamazoo, Michigan, United States, 49006
        • Recruiting
        • Planned Parenthood - Kalamazoo
        • Contact:
      • Lansing, Michigan, United States, 48912
        • Recruiting
        • Planned Parenthood - Lansing
        • Contact:
      • Livonia, Michigan, United States, 48154
        • Recruiting
        • Planned Parenthood - Livonia
        • Contact:
      • Traverse City, Michigan, United States, 49686
        • Recruiting
        • Planned Parenthood - Traverse City
        • Contact:
      • Warren, Michigan, United States, 48093
        • Recruiting
        • Planned Parenthood - Warren
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 second to 17 years (Child)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

The proposed project will analyze the outcomes of children ages 0 to 17 years old whose mothers enrolled in the Michigan Contraceptive Access, Research and Evaluation Study (M-CARES). M-CARES participation requires that mothers are:

  • 18-35 years old
  • physically capable (biologically female and fecund) and at risk of having a pregnancy,
  • not pregnant at the time of enrollment
  • not wishing to become pregnant in the 12 months after enrollment,
  • are seeking care at Planned Parenthood of Michigan, and
  • face out-of-pocket costs for contraceptives at Planned Parenthood of Michigan.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental Group
Mothers randomized to receive a voucher to be used at Planned Parenthood to cover the cost of contraceptives
Behavioral: Mother receives voucher valued at 100% of cost of name-brand IUD (March 4, 2019-March 31, 2023)
M-CARES randomized vouchers for contraception valued up to 100% of inserting a name-brand IUD (e.g., Skyla, Paraguard, Mirena) for women with out of pocket costs at Planned Parenthood. This intervention occurred from March 4, 2019, forward.
Behavioral: Mother receives voucher valued at 50% of cost of name-brand IUD (August 26, 2018-March 3, 2019)
M-CARES randomized vouchers for contraception valued up to 50% of inserting a name-brand IUD (e.g., Skyla, Paraguard, Mirena) for women with out of pocket costs at Planned Parenthood. This intervention occurred after November 4, 2019.
No Intervention: Control Group
Mothers randomized to NOT receive a voucher. Mothers in this arm receive the Planned Parenthood standard of care priced according to the Planned Parenthood sliding scale.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of siblings born after study enrollment (1 year)
Time Frame: Up to 1 year post enrollment
Number of children born to individual's mother as determined in mother's survey responses and Vital Records (count: 0, 1, 2....)
Up to 1 year post enrollment
Number of siblings born after study enrollment (3 year)
Time Frame: Up to 3 year post enrollment
Number of children born to individual's mother as determined in mother's survey responses and Vital Records (count: 0, 1, 2....)
Up to 3 year post enrollment
Number of siblings born after study enrollment (5 year)
Time Frame: Up to 5 year post enrollment
Number of children born to individual's mother as determined in mother's survey responses and Vital Records (count: 0, 1, 2....)
Up to 5 year post enrollment
Standardized achievement test score (1 year)
Time Frame: Up to 1 year post enrollment
Percentile on state standardized achievement test (range: 1-100)
Up to 1 year post enrollment
Standardized achievement test score (3 year)
Time Frame: Up to 3 year post enrollment
Percentile on state standardized achievement test (range: 1-100)
Up to 3 year post enrollment
Standardized achievement test score (5 year)
Time Frame: Up to 5 year post enrollment
Percentile on state standardized achievement test (range: 1-100)
Up to 5 year post enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Michigan

Collaborators

Planned Parenthood Federation of America
National Opinion Research Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 26, 2018

Primary Completion (Estimated)

December 31, 2049

Study Completion (Estimated)

December 31, 2049

Study Registration Dates

First Submitted

April 29, 2020

First Submitted That Met QC Criteria

April 29, 2020

First Posted (Actual)

May 1, 2020

Study Record Updates

Last Update Posted (Actual)

June 2, 2026

Last Update Submitted That Met QC Criteria

May 30, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • HUM00132909B

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Clinical Trials on Mother receives voucher valued at 100% of cost of name-brand IUD (March 4, 2019-March 31, 2023)

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