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Идёт набор NCT04371900

Michigan Contraceptive Access, Research, and Evaluation Study Children: Phase 1

Без фазы С лечением Pregnancy

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: 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).
Кому может быть актуально
Состояния в реестре: Pregnancy. Базовые параметры: 0 лет — 17 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
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Официальное название

The Effects of Unintended Pregnancy on Children

Обзор

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.

Подробное описание

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.

Вмешательства

  • Поведенческое 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.
  • Поведенческое 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.

Первичные конечные точки

  • Number of siblings born after study enrollment (1 year) [Срок оценки: Up to 1 year post enrollment]
  • Number of siblings born after study enrollment (3 year) [Срок оценки: Up to 3 year post enrollment]
  • Number of siblings born after study enrollment (5 year) [Срок оценки: Up to 5 year post enrollment]
  • Standardized achievement test score (1 year) [Срок оценки: Up to 1 year post enrollment]
  • Standardized achievement test score (3 year) [Срок оценки: Up to 3 year post enrollment]
  • Standardized achievement test score (5 year) [Срок оценки: Up to 5 year post enrollment]

Критерии участия

Критерии включения

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Профилактика

Центры проведения

США · 9 центров
  • 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
  • … и ещё 1 центр

Идентификаторы

NCT: NCT04371900 · HUM00132909B

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗