Pregnancy in Women With HIV Infection

NCT04350554 | Unknown

• 1 other identifier: RIS_EPICLIN_04_2020
• Study Type: observational
• Target: 160
• Locations: 0 countries
• Sites: N/A

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.

Conditions

HIV Infections; Pregnancy Related

Keywords

HIV; Pregnancy; Adverse pregnancy outcomes

Outcome Measures

Primary Outcomes (13)

• 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

Study Arms (2)

Retrospective pregnancies

Women recruited in CoRIS from January 2004 to November 2019 and who became pregnant during this period.

Other: Pregnancy

Prospective pregnancies

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

Interventions

Pregnancy OTHER

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

Retrospective pregnancies

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The Cohort of the Spanish AIDS Research Network (CoRIS) is a prospective multicentre cohort of HIV-positive treatment-naïve patients aged \>13 years, recruited from 46 centres from 13 Autonomous Regions in the Spanish public healthcare system. Recruitment and follow-up started in 2004 and are still ongoing. From 2004 to the last update in November 2018, 15,509 patients have been included in the cohort. This study will be performed using the update of November 2019, that will be available in June 2020.

You may qualify if:

• 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

Sponsors & Collaborators

• Carlos III Health Institute: lead
• Red Temática de Investigación Cooperativa en Sida: collaborator
• Merck Sharp & Dohme LLC: collaborator

MeSH Terms

Conditions

HIV Infections

Interventions

Pregnancy

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Reproduction; Reproductive Physiological Phenomena; Reproductive and Urinary Physiological Phenomena

Central Study Contacts

Inma Jarrin, PhD

CONTACT

0034918222863; ijarrin@isciii.es

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Scientific

Study Record Dates

• First Submitted: April 9, 2020
• First Posted: April 17, 2020
• Study Start: September 1, 2020
• Primary Completion: September 1, 2020
• Study Completion: June 30, 2021
• Last Updated: July 14, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share