Evidence map›Paper›PMID 31328328›Full record

ArticlePharmacoepidemiology and drug safety2019

Identifying pregnancies in insurance claims data: Methods and application to retinoid teratogenic surveillance.

Sarah C MacDonald, Jacqueline M Cohen, Alice Panchaud, Thomas F McElrath, Krista F Huybrechts, Sonia Hernández-Díaz

Abstract read
In one paragraph

Article in Pharmacoepidemiology and drug safety, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 67 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
67citing papers in PubMed, 1 pooled it
–field-weighted citation impact
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

67 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
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  15. Neonatal Outcome Ascertainment in Mother-Infant Paired Claims.Pharmacoepidemiology and drug safety · 2026
    Article
  16. Article
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  18. PregMedNet: Multifaceted Maternal Medication Impacts on Neonatal Complications.medRxiv : the preprint server for health sciences · 2025
    Article
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  20. Article

7 more citing papers are in PubMed but not listed here.

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

6 authors.

Sarah C MacDonaldDepartment of Epidemiology, Harvard T.H. Chan School of Public Health, Boston, Massachusetts.ORCID 0000-0001-6533-152X
Jacqueline M CohenDepartment of Epidemiology, Harvard T.H. Chan School of Public Health, Boston, Massachusetts.ORCID 0000-0002-7300-0488
Alice PanchaudDepartment of Epidemiology, Harvard T.H. Chan School of Public Health, Boston, Massachusetts.
Thomas F McElrathDivision of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts.
Krista F HuybrechtsDivision of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, Boston, Massachusetts.ORCID 0000-0001-5805-8430
Sonia Hernández-DíazDepartment of Epidemiology, Harvard T.H. Chan School of Public Health, Boston, Massachusetts.

Funding

The Training Program in Reproductive, Perinatal, and Pediatric Life Course EpidemiologyT32HD104612 · NICHD · HARVARD UNIVERSITY D/B/A HARVARD SCHOOL OF PUBLIC HEALTH · PI Sonia Hernandez-Diaz, Henning Tiemeier · 2021 to 2026
$2.2M
Comparative Safety of commonly prescribed Psychotropic Drugs in pregnant WomenR01MH100216 · NIMH · HARVARD SCHOOL OF PUBLIC HEALTH · PI HERNANDEZ-DIAZ, SONIA · 2014 to 2016
$1.4M
Pregnancy Registries Nested in International Pooled Health Care DatabasesR21HD092879 · NICHD · HARVARD SCHOOL OF PUBLIC HEALTH · PI HERNANDEZ-DIAZ, SONIA · 2017 to 2018
$478k
NICHD NIH HHS R21 HD092879NICHD NIH HHS T32 HD104612NIH HHS R21HD092879NIMH NIH HHS R01 MH100216
6 · The paper itself

Abstract

purposeThe purpose of the study is to develop an algorithm to identify pregnancies in administrative databases and apply it to assess pregnancy rates and outcomes in women prescribed isotretinoin or tretinoin.

methodsUsing the 2011 to 2015 Truven Health MarketScan Database, we identified pregnancies, including losses and terminations. In a cohort design, nonpregnant women filling a prescription for isotretinoin or tretinoin were matched to five women without either prescription. Women were followed for 365 days or until conception, medication discontinuation, or enrollment discontinuation ("prescription episode"). Rates of pregnancy, risks of pregnancy losses, and prevalence of infant malformations at birth were assessed by exposure.

resultsWe identified 2 179 192 livebirths, 8434 stillbirths, 2521 mixed births, 415 110 spontaneous abortions, 124 556 elective terminations, and 8974 unspecified abortions. There were 86 834 isotretinoin and 973 587 tretinoin episodes, matched to 5 302 105 unexposed women. Pregnancy rates were 3 (isotretinoin), 19 (tretinoin), and 34 (unexposed) per 1000 person-years. Risk of spontaneous pregnancy losses were similar; however, terminations were more common in the isotretinoin-exposed (28% [95% CI: 21%-36%]) than the tretinoin-exposed (10% [95% CI: 9%-11%]) or unexposed pregnancies (6%). Malformations occurred in 4.5% (95% CI: 3.5%-5.6%) of the tretinoin-exposed pregnancies and 4.2% of the unexposed pregnancies (adjusted odds ratio: 1.16 [95% CI: 0.85-1.58]); isotretinoin-exposed births were too few to assess malformations.

conclusionsAdministrative databases can complement risk evaluation and mitigation strategies (REMS) for known teratogens and contribute to safety surveillance for other medications. Here, isotretinoin-exposed pregnancy rates were low, but existent, and many pregnancies were terminated. Tretinoin exposure was not associated with a meaningfully elevated risk of losses or malformations as compared with unexposed pregnancies.

Indexed as

Abnormalities, Drug-InducedAdministrative Claims, HealthcareAdolescentAdultDatabases, FactualDrug PrescriptionsFemaleHumansInfant, NewbornIsotretinoinMaternal ExposureMiddle AgedPregnancyPregnancy OutcomePregnancy RatePrevalenceIsotretinoinTretinoinadministrative datahealthcare claimsisotretinoinpharmacoepidemiologypregnancytretinoin

Identifiers

PMID31328328
PMCPMC6830505

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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.