MedTrace Logo

Pregnancy in Women With HIV Infection

NCT04350554 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 160

Last updated 2020-07-14

No results posted yet for this study

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.

Conditions

  • HIV Infections
  • Pregnancy Related

Interventions

OTHER

Pregnancy

To measure and characterize pregnancies and describe the clinical course during pregnancy

OTHER

Pregnancy

To evaluate attitudes towards pregnancy (ie. planned pregnancy) and social support among women who become pregnant during the year 2020

Sponsors & Collaborators

  • Red Temática de Investigación Cooperativa en Sida

    collaborator UNKNOWN

  • Merck Sharp & Dohme LLC

    collaborator INDUSTRY

  • Carlos III Health Institute

    lead OTHER_GOV

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-01
Primary Completion
2020-09-01
Completion
2021-06-30

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04350554 on ClinicalTrials.gov