Characteristics and outcomes of pregnancies in the Maternal Outcomes Masterset real‐world database

Author:

Gibbs Liza R.12ORCID,Ali Ayad K.1ORCID,Albright Dawn G.3,Rubinstein Emily R.3ORCID,Klesh Reyna4ORCID,Zimmerman Ruth5ORCID,Garry Elizabeth M.1ORCID

Affiliation:

1. Scientific Research and Strategy Aetion, Inc. New York New York USA

2. Department of Epidemiology Boston University School of Public Health Boston Massachusetts USA

3. Scientific Data Insights Aetion, Inc. New York New York USA

4. Data Product & Innovation HealthVerity, Inc. Philadelphia Pennsylvania USA

5. Data Insights & Analytics HealthVerity, Inc. Philadelphia Pennsylvania USA

Abstract

AbstractPurposeDescribe patient characteristics and pregnancy outcomes among all pregnant patients, and additionally describe infant outcomes among the subset with linked infants in the Maternal Outcomes Masterset (MOM).MethodsWe used closed claims within the MOM data to identify publicly and privately insured patients at the first record of pregnancy January 1, 2018–December 1, 2021, with ≥180 days baseline enrollment. We described characteristics during baseline and follow‐up (until an observed pregnancy endpoint, disenrollment, or 42‐week maximum). We described maternal and infant characteristics overall and by infant linkage and contextualized them within national statistics.ResultsAmong the 1 438 861 pregnant patients meeting the study criteria, the most common pregnancy endpoint recorded was live birth (42%) followed by spontaneous abortion (14%). Among 602 721 patients with a live birth, 99% had a week‐specific gestational age recorded and 35% had at least one linked infant. Patients with infant linkage and sufficient follow‐up (N = 155 621) had similar baseline comorbidities, pregnancy complications, and gestational age at delivery as those without any linkage. However, more patients with linkage had commercial coverage (70% vs. 31%), and were therefore older (50% vs. 31% aged ≥30 years) and more likely to have an unknown race (57% vs. 34%).ConclusionsIn this large sample of pregnant patients, maternal and infant characteristics generally align with national statistics, providing confidence in the use of this data source for pregnancy research. Further, confirmation that the subset of patients with infant linkage is similar to the overall pregnancy cohort provides assurance that this subset can be considered representative.

Publisher

Wiley

Subject

Pharmacology (medical),Epidemiology

Reference24 articles.

1. Pregnant Women: Scientific and ethical considerations for inclusion in clinical trials guidance for industry.2018p. 14.

2. FDA/CDER/CBER.Postapproval pregnancy safety studies guidance for industry.2019p. 30.

3. FDA.NDA 214846.2021https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/214846Orig1s000ltr.pdf

4. FDA.NDA 213871.2022https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/213871Orig1s000ltr.pdf

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