Quality of Life in Women Using LARC Contraception: Cross-Sectional Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 427
- 主要终点
- Change in World Health Organization Quality of Life-BREF (WHOQOL-BREF) Total Score at 3 Months Post-Method Initiation
研究概览
简要总结
assessment of quality of life in women using LARC
详细描述
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)
研究设计
- 研究类型
- Observational
- 观察模型
- Case Crossover
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •women aged 18 to 45 years,
- •women used LARC contraception,
- •women agreed to participate.
排除标准
- •women using non LARC contraception,
- •women had any psychiatric disorder
研究组 & 干预措施
LNG-IUD (Levonorgestrel Intrauterine Device)
A hormonal intrauterine device (IUD) that releases levonorgestrel locally inside the uterus (e.g., Mirena or Kyleena).
The device provides long-term contraception for approximately 3-8 years depending on the model.
Its mechanism primarily involves endometrial thinning leading to reduced menstrual bleeding, with partial suppression of ovulation.
It is commonly preferred for women who require contraception along with management of heavy menstrual bleeding.
Participants using the LNG-IUD for at least 3 months will be included in this cohort.
干预措施: Levonorgestrel Intrauterine Device (Device)
Cu-IUD (Copper Intrauterine Device)
A non-hormonal copper intrauterine device (e.g., ParaGard or TCu-380A) used for long-term contraception.
The device releases copper ions that are toxic to sperm, creating an inflammatory uterine environment that prevents fertilization and implantation.
The contraceptive effect can last 5-12 years depending on the model. This method is commonly chosen by women who prefer hormone-free contraception or require an emergency contraception option.
Participants using the copper IUD for at least 3 months will be included in this cohort.
干预措施: Copper Intrauterine Device (Device)
Implanon(Etonogest Implant)
A hormonal subdermal contraceptive implant releasing etonogestrel (progestin-only).
The implant is inserted under the skin of the upper arm and provides continuous contraception for up to 3-5 years.
It works by suppressing ovulation, thickening cervical mucus, and thinning the endometrium.
This method is commonly used by women seeking long-acting reversible contraception (LARC) with minimal user action.
Participants using this method for at least 3 months will be included in this cohort.
干预措施: Etonogestrel Implant (Device)
结局指标
主要结局
Change in World Health Organization Quality of Life-BREF (WHOQOL-BREF) Total Score at 3 Months Post-Method Initiation
时间窗: Baseline and 3 months after contraceptive method initiation
Assessment of quality of life using the WHOQOL-BREF, a 26-item questionnaire with four domains (physical health, psychological well-being, social relationships, environmental factors). Raw domain scores are transformed to a 0-100 scale using the formula: \[(raw score - lowest possible)/range\] × 100. Scale range: 0 to 100 per domain; higher scores indicate better quality of life. Primary analysis will compare mean change in overall QoL score from baseline to 3 months between LARC and non-LARC groups
次要结局
- Mean Dysmenorrhea Severity Score Assessed by Visual Analogue Scale (VAS)(Baseline and 3 months after method initiation)
- Proportion of Participants Reporting Dysmenorrhea Assessed by Visual Analogue Scale (VAS) for Pain(Baseline and 3 months after method initiation)
- Change in Female Sexual Function Index (FSFI) Total Score(Baseline and 3 months after method initiation)
- Change in Depression Subscale Score of the Depression Anxiety Stress Scales-21 (DASS-21)(Baseline and 3 months after method initiation)
研究者
Aya Mohamed Abdelazeim
Doctor
Assiut University