Pregnancy in Women With HIV Infection

Study Overview
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Brief Summary
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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.

Official Title
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Pregnancy in Women With HIV Infection: a Multicenter Cohort in Spain

Conditions
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HIV Infections, Pregnancy Related

Intervention / Treatment
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* Other: Pregnancy
* Other: Pregnancy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Retrospective pregnancies<br>Women recruited in CoRIS from January 2004 to November 2019 and who became pregnant during this period. | Other: Pregnancy<br>* To measure and characterize pregnancies and describe the clinical course during pregnancy<br>|
| Prospective pregnancies<br>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. | Other: Pregnancy<br>* To evaluate attitudes towards pregnancy (ie. planned pregnancy) and social support among women who become pregnant during the year 2020<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of pregnancies |  | From 2004 to 2019 | 
| Epidemiological characteristics of women who become pregnant | Proportion of diagnostic delay among women diagnosed with HIV infection after becoming pregnant | 2004 to 2019 | 
| Clinical course during pregnancy | Proportion of women with undetectable viral load at week 36 of pregnancy | 2004 to 2019 | 
| Opportunistic infections during pregnancy | Incidence of opportunistic infections throughout pregnancy | 2004 to 2019 | 
| Persistence of Antiretroviral treatment (ART) during pregnancy | Time from ART initition to treatment change during pregnancy | 2004 to 2019 | 
| Antiretroviral treatment (ART) administered to pregnant women | Distribution of ART regimens administered to women at pregnancy | 2004 to 2019 | 
| Follow-up after pregnancy | Rate of lost-to-follow-up during the first year after pregnancy termination | 2004 to 2019 | 
| Clinical outcomes after pregnancy | Proportion of women with undetectable viral load 6 months after pregnancy termination | 2004 to 2019 | 
| Outcome of the conception | Proportion of interrupted pregnancies, spontaneous abortions and term pregnancies | 2004 to 2019 | 
| Term pregnancies | Proportion of term pregnancies | 2004 to 2019 | 
| Type of delivery | Proportion of vaginal deliveries | 2004 to 2019 | 
| HIV infection of the newborn | Proportion of newborns with HIV infections | 2004 to 2019 | 
| Attitudes towards pregnancy | Proportion of unintended pregnancies (unplanned or unwanted at the time of conception) | Pregnancies during the year 2020 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, Pregnancy, Adverse pregnancy outcomes