Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
160 participants
OBSERVATIONAL
2020-09-01
2021-06-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
OTHER
Study Groups
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Retrospective pregnancies
Women recruited in CoRIS from January 2004 to November 2019 and who became pregnant during this period.
Pregnancy
To measure and characterize pregnancies and describe the clinical course during pregnancy
Prospective pregnancies
Women recruited in CoRIS from January 2004 to November 2019 who will become pregnant during the year 2020 and who agree to participate in a telephone survey.
Pregnancy
To evaluate attitudes towards pregnancy (ie. planned pregnancy) and social support among women who become pregnant during the year 2020
Interventions
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Pregnancy
To measure and characterize pregnancies and describe the clinical course during pregnancy
Pregnancy
To evaluate attitudes towards pregnancy (ie. planned pregnancy) and social support among women who become pregnant during the year 2020
Eligibility Criteria
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Inclusion Criteria
* Became pregnant from January 2004 to November 2019
* or become pregnant during the year 2020 and agree to participate in a telephone survey
18 Years
FEMALE
No
Sponsors
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Red Temática de Investigación Cooperativa en Sida
UNKNOWN
Merck Sharp & Dohme LLC
INDUSTRY
Carlos III Health Institute
OTHER_GOV
Responsible Party
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Inmaculada Jarrín Vera
Scientific
Central Contacts
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Other Identifiers
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RIS_EPICLIN_04_2020
Identifier Type: -
Identifier Source: org_study_id
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