Pregnancy in Women With HIV Infection

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04350554
• Other study ID #: RIS_EPICLIN_04_2020
• Status: Not yet recruiting
• Start date: September 1, 2020
• Est. completion date: June 30, 2021

Study information

• Verified date: July 2020
• Source: Carlos III Health Institute
• Contact: Inma Jarrin, PhD
• Phone: 0034918222863
• Email: ijarrin[@]isciii.es
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 160
• Est. completion date: June 30, 2021
• Est. primary completion date: September 1, 2020
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• Communicable Diseases
• HIV Infections
• Infection
• Pregnancy Related

Intervention

Other:
• Pregnancy
To measure and characterize pregnancies and describe the clinical course during pregnancy
• Pregnancy
To evaluate attitudes towards pregnancy (ie. planned pregnancy) and social support among women who become pregnant during the year 2020

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Carlos III Health Institute	Merck Sharp & Dohme Corp., Red Temática de Investigación Cooperativa en Sida

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of pregnancies		From 2004 to 2019
Primary	Epidemiological characteristics of women who become pregnant	Proportion of diagnostic delay among women diagnosed with HIV infection after becoming pregnant	2004 to 2019
Primary	Clinical course during pregnancy	Proportion of women with undetectable viral load at week 36 of pregnancy	2004 to 2019
Primary	Opportunistic infections during pregnancy	Incidence of opportunistic infections throughout pregnancy	2004 to 2019
Primary	Persistence of Antiretroviral treatment (ART) during pregnancy	Time from ART initition to treatment change during pregnancy	2004 to 2019
Primary	Antiretroviral treatment (ART) administered to pregnant women	Distribution of ART regimens administered to women at pregnancy	2004 to 2019
Primary	Follow-up after pregnancy	Rate of lost-to-follow-up during the first year after pregnancy termination	2004 to 2019
Primary	Clinical outcomes after pregnancy	Proportion of women with undetectable viral load 6 months after pregnancy termination	2004 to 2019
Primary	Outcome of the conception	Proportion of interrupted pregnancies, spontaneous abortions and term pregnancies	2004 to 2019
Primary	Term pregnancies	Proportion of term pregnancies	2004 to 2019
Primary	Type of delivery	Proportion of vaginal deliveries	2004 to 2019
Primary	HIV infection of the newborn	Proportion of newborns with HIV infections	2004 to 2019
Primary	Attitudes towards pregnancy	Proportion of unintended pregnancies (unplanned or unwanted at the time of conception)	Pregnancies during the year 2020