Pregnancy in Women With HIV Infection: a Multicenter Cohort in Spain
试验速览
- 阶段
- 不适用
- 入组人数
- 160
- 主要终点
- Antiretroviral treatment (ART) administered to pregnant women
研究概览
简要总结
Women living with HIV face multiple challenges regarding pregnancy, encompassing not only their intention to procreate, but also difficulties during the course of pregnancy.
Compared to HIV-negative controls, HIV-infected women have a higher risk of pregnancy complications such as preeclampsia, gestational diabetes, or preterm labor. In addition, the treatment of HIV among pregnant women entails specific difficulties, such as changes in bioavailability of antiretroviral drugs, or the concern about the association of certain antiretrovirals with adverse pregnancy outcomes.
There is very little evidence about pregnancy among women living with HIV in Spain. Very few studies have been published, performed in single centers or in small cohorts with a limited number of patients. The Cohort of the Spanish AIDS Research Network (CoRIS) offers a unique setting to answer questions that are unlikely to be answered by a single study.
The aims of this study are (i) to describe the incidence of pregnancies and their temporal trends from 2004 to 2019, (ii) o describe the clinical and epidemiological characteristics of women who become pregnant, (iii) to assess the diagnostic delay among women diagnosed with HIV infection after becoming pregnant, (iv) to investigate the clinical course during pregnancy and its predictive factors, (v) to describe the antiretroviral treatment administered to pregnant women, (vi) to describe clinical outcomes after pregnancy, (vii) to describe the outcome of the conception in terms of interrupted pregnancies, spontaneous abortions, term pregnancies, type of delivery (vaginal or caesarean section) and HIV infection of the newborn, and (vii) to evaluate attitudes towards pregnancy (ie. planned pregnancy) and social support among women who become pregnant during the year 2020.
Study population will be women from the cohort of the Spanish AIDS Research Network (CoRIS) who have become pregnant in the period 2004-2010.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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
- •HIV-positive women recruited in CoRIS
- •Became pregnant from January 2004 to November 2019
- •or become pregnant during the year 2020 and agree to participate in a telephone survey
排除标准
- 未提供
结局指标
主要结局
Antiretroviral treatment (ART) administered to pregnant women
时间窗: 2004 to 2019
Distribution of ART regimens administered to women at pregnancy
Clinical course during pregnancy
时间窗: 2004 to 2019
Proportion of women with undetectable viral load at week 36 of pregnancy
Incidence of pregnancies
时间窗: From 2004 to 2019
Epidemiological characteristics of women who become pregnant
时间窗: 2004 to 2019
Proportion of diagnostic delay among women diagnosed with HIV infection after becoming pregnant
Follow-up after pregnancy
时间窗: 2004 to 2019
Rate of lost-to-follow-up during the first year after pregnancy termination
Clinical outcomes after pregnancy
时间窗: 2004 to 2019
Proportion of women with undetectable viral load 6 months after pregnancy termination
Opportunistic infections during pregnancy
时间窗: 2004 to 2019
Incidence of opportunistic infections throughout pregnancy
Persistence of Antiretroviral treatment (ART) during pregnancy
时间窗: 2004 to 2019
Time from ART initition to treatment change during pregnancy
Outcome of the conception
时间窗: 2004 to 2019
Proportion of interrupted pregnancies, spontaneous abortions and term pregnancies
Term pregnancies
时间窗: 2004 to 2019
Proportion of term pregnancies
Type of delivery
时间窗: 2004 to 2019
Proportion of vaginal deliveries
Attitudes towards pregnancy
时间窗: Pregnancies during the year 2020
Proportion of unintended pregnancies (unplanned or unwanted at the time of conception)
HIV infection of the newborn
时间窗: 2004 to 2019
Proportion of newborns with HIV infections
次要结局
未报告次要终点
研究者
Inmaculada Jarrín Vera
Scientific
Carlos III Health Institute
