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Набор скоро начнётся NCT07509138

Quality of Life in Women Using LARC Contraception

Наблюдательное Quality of Life

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: Etonogestrel Implant, Levonorgestrel Intrauterine Device, Copper Intrauterine Device.
Кому может быть актуально
Состояния в реестре: Quality of Life. Базовые параметры: 18 лет — 45 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Quality of Life in Women Using LARC Contraception: Cross-Sectional Study

Обзор

assessment of quality of life in women using LARC

Подробное описание

The ability to control one's fertility is a cornerstone of reproductive health and personal autonomy, fundamentally influencing women's educational, economic, and social trajectories. Modern contraception provides this control, offering a diverse range of methods that allow women and couples to plan if and when to have children. The choice of contraceptive method is a deeply personal decision, often guided by a complex interplay of medical history, lifestyle, personal values, and an individual's priorities regarding efficacy, convenience, and potential side effects (Bangar \& Bansal, 2023).

Long-Acting Reversible Contraception (LARC) emerged as a highly effective and increasingly popular category. LARC methods are distinguished by their requirement for administration by a healthcare provider but offer protection against pregnancy for an extended period, ranging from three to ten years, without any ongoing user action. Their "forget-and-forget" nature eliminates the need for daily, weekly, or monthly adherence, resulting in typical-use effectiveness rates that rival those of permanent sterilization. (Francis et al., 2024).

While the clinical effectiveness of LARC in preventing pregnancy is well-established, a comprehensive understanding of its impact must extend beyond this singular outcome to encompass the broader concept of quality of life (QoL). Quality of life is a multidimensional construct that includes physical well-being, psychological state, social relationships, and environmental factors. For a woman using contraception, QoL is affected not only by her confidence in avoiding an unintended pregnancy but also by her experience with method-related side effects (such as changes in bleeding patterns, mood, or weight), the convenience of use, and the overall sense of control over her reproductive health. (Alsammani \& Ahmed, 2023)

Вмешательства

  • Устройство Etonogestrel Implant
    Insertion of a single etonogestrel-releasing subdermal contraceptive implant in the upper arm by a trained healthcare provider according to standard clinical practice.
  • Устройство Levonorgestrel Intrauterine Device
    Insertion of a levonorgestrel-releasing intrauterine device into the uterine cavity by a trained healthcare provider for long-acting contraception.
  • Устройство Copper Intrauterine Device
    Insertion of a copper intrauterine device into the uterine cavity by a trained healthcare provider as a non-hormonal long-acting contraceptive method.

Первичные конечные точки

  • Change in World Health Organization Quality of Life-BREF (WHOQOL-BREF) Total Score at 3 Months Post-Method Initiation [Срок оценки: Baseline and 3 months after contraceptive method initiation]
Вторичные конечные точки (4)
  • Proportion of Participants Reporting Dysmenorrhea Assessed by Visual Analogue Scale (VAS) for Pain [Срок оценки: Baseline and 3 months after method initiation]
  • Mean Dysmenorrhea Severity Score Assessed by Visual Analogue Scale (VAS) [Срок оценки: Baseline and 3 months after method initiation]
  • Change in Female Sexual Function Index (FSFI) Total Score [Срок оценки: Baseline and 3 months after method initiation]
  • Change in Depression Subscale Score of the Depression Anxiety Stress Scales-21 (DASS-21) [Срок оценки: Baseline and 3 months after method initiation]

Критерии участия

Критерии включения

  • women aged 18 to 45 years,

women used LARC contraception,

women agreed to participate.

Критерии исключения

  • women using non LARC contraception,

women had any psychiatric disorder

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

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Случай-кроссовер

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07509138 · LARC-Contraception-QoL

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗