HIV Infections, Pregnancy Related
Conditions
Keywords
HIV, Pregnancy, Adverse pregnancy outcomes
Brief summary
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.
Interventions
OTHERPregnancy
To measure and characterize pregnancies and describe the clinical course during pregnancy
Sponsors
Red Temática de Investigación Cooperativa en Sida
Merck Sharp & Dohme LLC
Carlos III Health Institute
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of pregnancies | From 2004 to 2019 | — |
| Epidemiological characteristics of women who become pregnant | 2004 to 2019 | Proportion of diagnostic delay among women diagnosed with HIV infection after becoming pregnant |
| Clinical course during pregnancy | 2004 to 2019 | Proportion of women with undetectable viral load at week 36 of pregnancy |
| Opportunistic infections during pregnancy | 2004 to 2019 | Incidence of opportunistic infections throughout pregnancy |
| Persistence of Antiretroviral treatment (ART) during pregnancy | 2004 to 2019 | Time from ART initition to treatment change during pregnancy |
| Antiretroviral treatment (ART) administered to pregnant women | 2004 to 2019 | Distribution of ART regimens administered to women at pregnancy |
| Follow-up after pregnancy | 2004 to 2019 | Rate of lost-to-follow-up during the first year after pregnancy termination |
| Clinical outcomes after pregnancy | 2004 to 2019 | Proportion of women with undetectable viral load 6 months after pregnancy termination |
| Outcome of the conception | 2004 to 2019 | Proportion of interrupted pregnancies, spontaneous abortions and term pregnancies |
| Term pregnancies | 2004 to 2019 | Proportion of term pregnancies |
| Type of delivery | 2004 to 2019 | Proportion of vaginal deliveries |
| HIV infection of the newborn | 2004 to 2019 | Proportion of newborns with HIV infections |
| Attitudes towards pregnancy | Pregnancies during the year 2020 | Proportion of unintended pregnancies (unplanned or unwanted at the time of conception) |
Contacts
Primary ContactInma Jarrin, PhD
Outcome results
None listed