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Not yet recruiting NCT07509138

Quality of Life in Women Using LARC Contraception

Observational Quality of Life

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: Etonogestrel Implant, Levonorgestrel Intrauterine Device, Copper Intrauterine Device.
Who it may be relevant to
Registry conditions: Quality of Life. Basic parameters: 18 years — 45 years · Female.
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
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

assessment of quality of life in women using LARC

Detailed description

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)

Interventions

  • Device 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.
  • Device Levonorgestrel Intrauterine Device
    Insertion of a levonorgestrel-releasing intrauterine device into the uterine cavity by a trained healthcare provider for long-acting contraception.
  • Device 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.

Primary outcome measures

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

Eligibility criteria

Inclusion criteria

  • women aged 18 to 45 years,

women used LARC contraception,

women agreed to participate.

Exclusion criteria

  • women using non LARC contraception,

women had any psychiatric disorder

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Case-crossover

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07509138 · LARC-Contraception-QoL

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗