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临床试验/NCT04371900
NCT04371900招募中不适用

The Effects of Unintended Pregnancy on Children

University of Michigan9 个研究点 分布在 1 个国家目标入组 4,700 人开始时间: 2018年8月26日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
4,700
试验地点
9
主要终点
Number of siblings born after study enrollment (1 year)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
0 Years 至 17 Years(Child)
性别
All
接受健康志愿者
是

入选标准

  • •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.

排除标准

  • 未提供

研究组 & 干预措施

Experimental Group

Experimental

Mothers randomized to receive a voucher to be used at Planned Parenthood to cover the cost of contraceptives

干预措施: Mother receives voucher valued at 100% of cost of name-brand IUD (March 4, 2019-March 31, 2023) (Behavioral)

Experimental Group

Experimental

Mothers randomized to receive a voucher to be used at Planned Parenthood to cover the cost of contraceptives

干预措施: Mother receives voucher valued at 50% of cost of name-brand IUD (August 26, 2018-March 3, 2019) (Behavioral)

Control Group

No Intervention

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.

结局指标

主要结局

Number of siblings born after study enrollment (1 year)

时间窗: 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....)

Number of siblings born after study enrollment (3 year)

时间窗: 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....)

Number of siblings born after study enrollment (5 year)

时间窗: 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....)

Standardized achievement test score (1 year)

时间窗: Up to 1 year post enrollment

Percentile on state standardized achievement test (range: 1-100)

Standardized achievement test score (3 year)

时间窗: Up to 3 year post enrollment

Percentile on state standardized achievement test (range: 1-100)

Standardized achievement test score (5 year)

时间窗: Up to 5 year post enrollment

Percentile on state standardized achievement test (range: 1-100)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Martha Bailey

Adjunct Research Professor, Population Studies Center

University of Michigan

研究点 (9)

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