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Clinical Trials/NCT04350554
NCT04350554
Unknown
Not Applicable

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

Carlos III Health Institute0 sites160 target enrollmentSeptember 1, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
HIV Infections
Sponsor
Carlos III Health Institute
Enrollment
160
Primary Endpoint
Antiretroviral treatment (ART) administered to pregnant women
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 1, 2020
End Date
June 30, 2021
Last Updated
5 years ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Inmaculada Jarrín Vera

Scientific

Carlos III Health Institute

Eligibility Criteria

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

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Antiretroviral treatment (ART) administered to pregnant women

Time Frame: 2004 to 2019

Distribution of ART regimens administered to women at pregnancy

Clinical course during pregnancy

Time Frame: 2004 to 2019

Proportion of women with undetectable viral load at week 36 of pregnancy

Incidence of pregnancies

Time Frame: From 2004 to 2019

Epidemiological characteristics of women who become pregnant

Time Frame: 2004 to 2019

Proportion of diagnostic delay among women diagnosed with HIV infection after becoming pregnant

Follow-up after pregnancy

Time Frame: 2004 to 2019

Rate of lost-to-follow-up during the first year after pregnancy termination

Clinical outcomes after pregnancy

Time Frame: 2004 to 2019

Proportion of women with undetectable viral load 6 months after pregnancy termination

Opportunistic infections during pregnancy

Time Frame: 2004 to 2019

Incidence of opportunistic infections throughout pregnancy

Persistence of Antiretroviral treatment (ART) during pregnancy

Time Frame: 2004 to 2019

Time from ART initition to treatment change during pregnancy

Outcome of the conception

Time Frame: 2004 to 2019

Proportion of interrupted pregnancies, spontaneous abortions and term pregnancies

Term pregnancies

Time Frame: 2004 to 2019

Proportion of term pregnancies

Type of delivery

Time Frame: 2004 to 2019

Proportion of vaginal deliveries

Attitudes towards pregnancy

Time Frame: Pregnancies during the year 2020

Proportion of unintended pregnancies (unplanned or unwanted at the time of conception)

HIV infection of the newborn

Time Frame: 2004 to 2019

Proportion of newborns with HIV infections

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