Michigan Contraceptive Access, Research, and Evaluation Study Children: Phase 1
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Mother receives voucher valued at 100% of cost of name-brand IUD (March 4, 2019-March 31, 2023), Mother receives voucher valued at 50% of cost of name-brand IUD (August 26, 2018-March 3, 2019).
- Who it may be relevant to
- Registry conditions: Pregnancy. Basic parameters: 0 years — 17 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Effects of Unintended Pregnancy on Children
Overview
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.
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.
Interventions
- 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.
Primary outcome measures
- Number of siblings born after study enrollment (1 year) [Time frame: 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 siblings born after study enrollment (5 year) [Time frame: Up to 5 year post enrollment]
- Standardized achievement test score (1 year) [Time frame: Up to 1 year post enrollment]
- Standardized achievement test score (3 year) [Time frame: Up to 3 year post enrollment]
- Standardized achievement test score (5 year) [Time frame: Up to 5 year post enrollment]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
United States · 9 centers
- Planned Parenthood - Ann Arbor-West — Ann Arbor
- Planned Parenthood - Detroit — Detroit
- Planned Parenthood - Ferndale — Ferndale
- Planned Parenthood - Grand Rapids — Grand Rapids
- Planned Parenthood - Kalamazoo — Kalamazoo
- Planned Parenthood - Lansing — Lansing
- Planned Parenthood - Livonia — Livonia
- Planned Parenthood - Traverse City — Traverse City
- … and 1 more center
Identifiers
NCT: NCT04371900 · HUM00132909B