Quality of Life Related to the Care of Women Living With HIV During the Perinatal Period
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Collection of perceptions of pregnancy care via the Hospital Anxiety and Depression Scale
研究概览
简要总结
"The improvement of patient care by assessing the Quality of Life Related to Care (QLRC) in pregnant women living with HIV is of great importance for informing decision-making, resource allocation, and health policy formulation Prospective descriptive survey of women living with HIV followed for a pregnancy in the Infectious diseases department of Bichat-Claude Bernard Hospital, PARIS, France, between the first obstetric ultrasound and the 28th week of amenorrhea.
After recruitment during a follow-up consultation:
Information regarding the prenatal and perinatal management of HIV and the infant's outcomes up to 12 months will be collected retrospectively through the medical records.
Three self-questionnaires, either completed independently or with assistance, will be administered at inclusion (between the first obstetric ultrasound and 28 weeks of amenorrhea), during the third trimester of pregnancy, and at 1 year postpartum."
详细描述
"The latest report from the WHO shows that with 1.3 million (between 970,000 and 1.6 million) HIV-positive pregnant women worldwide in 2020, HIV continues to be a major global public health issue. In France, approximately 2 out of 1,000 pregnant women are infected with HIV, resulting in about 1,500 births per year over the past fifteen years. Although therapeutic advances have not yet led to a cure for the infection, they have increased life expectancy, improved the quality of life for people living with HIV, and reduced mother-to-child transmission during pregnancy, childbirth, and breastfeeding. Indeed, the very low transmission rate during replication has been completely eliminated.
The measurement of quality of life is increasingly used to complement the clinical or biological management of a disease, as it provides data to evaluate the quality of patient care, identify additional care needs, and assess the effectiveness of interventions. This approach enhances patient experience and satisfaction with treatment, in contrast to traditional management, which focuses on disease progression.
Generally, pregnant women report a lower health-related quality of life due to the impact of pregnancy on their physiological and mental health. In addition to limited physical activities in early pregnancy, most pregnant women are likely to experience nausea, vomiting, dizziness, depression, nervousness, and anxiety throughout their pregnancy. Compared to HIV-negative pregnant women, HIV-positive pregnant women may also have poorer physical health, a greater susceptibility to depression, and worse mental health. Factors such as education level, number of children, pregnancy symptoms, and occupation are key determinants of Health-Related Quality of Life (HRQoL) for pregnant women.
Consequently, improving patient care by assessing HRQoL in HIV-positive pregnant women is crucial for informing decision-making, resource allocation, and health policy formulation.
Through this project, we will explore the HRQoL of women living with HIV during the perinatal period under the care of the Infectious diseases department at Bichat-Claude Bernard Hospital, PARIS, FRANCE.
研究设计
- 研究类型
- Observational
- 观察模型
- Family Based
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •"Inclusion Criteria
- •Woman living with HIV
- •Age ≥ 18 years
- •Pregnant - due date between the first obstetric ultrasound and 28 weeks of amenorrhea
- •Information provided about the study and the right to refuse participation
排除标准
- •Refusal to participate in the study
- •Non-French speaker"
结局指标
主要结局
Collection of perceptions of pregnancy care via the Hospital Anxiety and Depression Scale
时间窗: during the Perinatal Period at 1 Year Postpartum
次要结局
- Describe the sociodemographic characteristics of the mothers(up to 1 year postpartum)
- Describe the course of pregnancy period through different parameters: HIV discovery setting, type of mother's income, administrative status, mother treatments, immunovirological control, intrapartum AZT infusion(up to 9 month)
- Describe the course of the postpartum period through different parameters: type of mother's income, administrative status, mother and child treatments, immunovirological control, delivery method, characteristics of newborns at birth(at 1 year postpartum)
- Describe the care of children born to women living with HIV : Collection of clinical and epidemiological data from children(up to 1 year)
- Describe the sharing of HIV status with the partner during pregnancy: yes or no and the reason for not sharing(up to 1 year postpartum)
- Describe the evolution of the mother's anxiety and depression(up to 1 year postpartum)
- Describe the serological status of children born to women living with HIV (HIV+ or HIV-)(at 1 year)
- Collection of perceptions of pregnancy care(at 1 year postpartum)
- Describe the mother's perception of the care of the newborn(at 1 year postpartum)
- Describe the mother's perception of the possibility of breastfeeding and conditions associated with breastfeeding(up to 1 year postpartum)
- Describe the reasons for non-inclusions: Patient refusal, Doctor refusal; Term pregnancy after 28 weeks; Does not speak French; Doesn't have time; Other(1 day)
- Describe the perception of the management of the previous pregnancy(1 day)
- describe breastfeeding practices(up to one year)
- Describe maternal virological conditions associated with breastfeeding(up to one year)
- describe pediatric conditions associated with breastfeeding(up to one year)