Pregnancy in Women With HIV Infection

C

Carlos III Health Institute

Status

Unknown

Conditions

Pregnancy Related
HIV Infections

Treatments

Other: Pregnancy

Study type

Observational

Funder types

Other
Industry

Identifiers

NCT04350554
RIS_EPICLIN_04_2020

Details and patient eligibility

About

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.

Enrollment

160 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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

Trial design

160 participants in 2 patient groups

Retrospective pregnancies
Description:
Women recruited in CoRIS from January 2004 to November 2019 and who became pregnant during this period.
Treatment:
Other: Pregnancy
Prospective pregnancies
Description:
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.
Treatment:
Other: Pregnancy

Trial contacts and locations

0

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Central trial contact

Inma Jarrin, PhD

Data sourced from clinicaltrials.gov

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