Evidence map›Paper›PMID 37307279›Full record

ArticlePloS one2023

Congenital malformations and preeclampsia associated with integrase inhibitor use in pregnancy: A single-center analysis.

Christiana Smith, Angela J Fought, Joyce F Sung, Jennifer R McKinney, Torri D Metz, Kirk B Fetters, Sarah Lazarus, Shannon Capraro, Emily Barr, Carrie Glenny and 3 more

Open access · goldAbstract read
In one paragraph

Article in PloS one, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 1 pooled it
1.2field-weighted citation impact, top 23% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 1 synthesis or guideline pooled it, 6 citations in OpenAlex.

  1. Pooled it
  2. Review
  3. Article
  4. Article
  5. Article
  6. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors at 8 institutions in 1 country.

Christiana SmithDepartment of Pediatrics, University of Colorado, Aurora, CO, United States of America.ORCID 0000-0002-4611-6477
Angela J FoughtUniversity of Colorado, Aurora, CO, United States of America.
Joyce F SungUniversity of Colorado, Aurora, CO, United States of America.
Jennifer R McKinneyBaylor College of Medicine, Houston, TX, United States of America.ORCID 0000-0002-1641-9610
Torri D MetzUniversity of Utah Health, Salt Lake City, UT, United States of America.
Kirk B FettersDepartment of Medicine, Harbor-UCLA Medical Center, Torrance, CA, United States of America.ORCID 0000-0001-6903-0644
Sarah LazarusUniversity of Wisconsin, Madison, WI, United States of America.
Shannon CapraroDepartment of Pediatrics, Children's Mercy Hospital, Kansas City, MO, United States of America.
Emily BarrUT Health Houston, Cizik School of Nursing, Houston, TX, United States of America.
Carrie GlennyChildren's Hospital Colorado, Aurora, CO, United States of America.
Jenna BuehlerUniversity of Colorado, Aurora, CO, United States of America.
Adriana WeinbergDepartment of Pediatrics, University of Colorado, Aurora, CO, United States of America.ORCID 0000-0001-6920-0623
CHIP Perinatal Medical Team
University of Colorado Anschutz Medical Campus · USBaylor College of Medicine · USChildren's Hospital Colorado · USChildren's Mercy Hospital · USThe University of Texas Health Science Center at Houston · USUCLA Medical Center · USUniversity of Utah · USUniversity of Wisconsin–Madison · US

Funding

LOC: HIV Prevention Trials NetworkUM1AI068619 · NIAID · FAMILY HEALTH INTERNATIONAL · PI Sinead Delany-Moretlwe, RAPHAEL J LANDOVITZ · 2011 to 2026
$779.5M
The Adolescent Master Protocol (AMP) Up Series ProjectP01HD103133 · NICHD · HARVARD UNIVERSITY D/B/A HARVARD SCHOOL OF PUBLIC HEALTH · PI CHADWICK, ELLEN GOULD, HERNANDEZ-DIAZ, SONIA · 2020 to 2024
$88.3M
NIH Prior Approval Process ProfessionalUL1TR002535 · NCATS · UNIVERSITY OF COLORADO DENVER · PI SOKOL, RONALD J. · 2018 to 2022
$51.1M
University of Colorado Denver Adolescent Trials Network UnitU01HD068063 · NICHD · UNIVERSITY OF COLORADO DENVER · PI MCFARLAND, ELIZABETH JANE · 2011 to 2015
$2.3M
NCATS NIH HHS UL1 TR002535NIAID NIH HHS UM1 AI068619NICHD NIH HHS HHSN275201800001CNICHD NIH HHS HHSN275201800001INICHD NIH HHS P01 HD103133NICHD NIH HHS U01 HD068063
6 · The paper itself

Abstract

backgroundAntiretroviral therapy (ART) decreases perinatal HIV transmission, but concerns exist regarding maternal and infant safety. We compared the incidence of congenital malformations and other adverse outcomes in pregnancies exposed to integrase inhibitor (INSTI) versus non-INSTI ART.

settingSingle-site review of all pregnancies among women living with HIV between 2008 and 2018.

methodsWe used binomial family generalized estimating equations to model the relationship of congenital anomalies and pregnancy outcomes with exposure to INSTI or dolutegravir (DTG) versus non-INSTI ART.

resultsAmong 257 pregnancies, 77 women received ≥1 INSTI (54 DTG, 14 elvitegravir, 15 raltegravir), 167 received non-INSTI, and 3 had missing data. Fifty congenital anomalies were identified in 36 infants. Infants with first-trimester DTG or any first-trimester INSTI exposure had higher odds of congenital anomalies than infants with first-trimester non-INSTI exposure (OR = 2.55; 95%CI = 1.07-6.10; OR = 2.61; 95%CI = 1.15-5.94, respectively). Infants with INSTI exposure after the second trimester had no increased odds of anomalies. Women with INSTI exposure had higher odds of preeclampsia (OR = 4.73; 95%CI = 1.70-13.19). Among women who received INSTI, grade ≥3 laboratory abnormalities were noted in 2.6% while receiving the INSTI and 3.9% while not receiving the INSTI, versus 16.2% in women who received non-INSTI. There was no association between INSTI exposure and other pregnancy outcomes.

conclusionIn our cohort, first-trimester INSTI exposure was associated with increased rates of congenital anomalies and use of INSTI during pregnancy was associated with preeclampsia. These findings underscore the need for continued monitoring of the safety of INSTI in pregnancy.

Indexed as

Abnormalities, Drug-InducedHIV Integrase InhibitorsMaternal ExposureAnti-Retroviral AgentsCohort StudiesDolutegravirFemaleHIV InfectionsHumansInfantInfant, NewbornMalePre-EclampsiaPregnancyPregnancy Trimester, FirstRetrospective StudiesAnti-Retroviral AgentsDolutegravirHIV Integrase Inhibitors

Identifiers

PMID37307279
PMCPMC10259792
OpenAlexW4380318497

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.