A Validation Study on the Frequency and Natural History of Miscarriages Using the Spanish Primary Care Database BIFAP

(1) Background: There is a major gap of knowledge towards the natural history of miscarriages in electronic medical records. We aimed to calculate the frequency of miscarriages using data from BIFAP database. (2) Methods: We identified all pregnancy losses and carried out a multistep validation exer...

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Main Authors: Sara Sanchez Ortiz, Consuelo Huerta, Ana Llorente-García, Paloma Ortega, Paloma Astasio, Lucía Cea-Soriano
Format: Article
Language:English
Published: MDPI AG 2021-05-01
Series:Healthcare
Subjects:
Online Access:https://www.mdpi.com/2227-9032/9/5/596
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author Sara Sanchez Ortiz
Consuelo Huerta
Ana Llorente-García
Paloma Ortega
Paloma Astasio
Lucía Cea-Soriano
author_facet Sara Sanchez Ortiz
Consuelo Huerta
Ana Llorente-García
Paloma Ortega
Paloma Astasio
Lucía Cea-Soriano
author_sort Sara Sanchez Ortiz
collection DOAJ
description (1) Background: There is a major gap of knowledge towards the natural history of miscarriages in electronic medical records. We aimed to calculate the frequency of miscarriages using data from BIFAP database. (2) Methods: We identified all pregnancy losses and carried out a multistep validation exercise. Potential cases with positive predictive values (PPV) of miscarriage confirmation <85% or those confirming other pregnancy loss were excluded. Kaplan–Meier figures and incidence rates (IRs) of miscarriage with 95% confidence intervals (CIs) expressed by 1000 person-weeks were calculated. Stratifying analysis by age, specific high-risk groups, and drug exposure within the pre-pregnancy period were performed restricted to women with recording last menstrual period (LMP). (3) Results: Women with confirmed miscarriage (<i>N</i> = 18,070), tended to be older, with higher frequency of comorbidities and drug utilization. Restricting to women with LPM recorded, IR of miscarriage was 10.89 (CI 95% 10.68–11.10) per 1000 women-weeks, with a median follow-up of 10 weeks (IQR: 8–12). The IR according to age was: 2.71 (CI 95% 2.59–2.84) in those aged <30 years compared to 9.11 (CI 95% 8.55–9.70) in women aged ≥40 years. Advanced maternal age (Hazard Ratio (HR, 95% confidence interval) CI 95%: 3.34 (3.08–3.62)), use of antihypertensives (1.49 (1.21–1.84), and use of drugs classified as D or X during pregnancy (1.17 (1.07–1.29)) showed to be positive predictors associated with increased risk of miscarriages. (4) Conclusion: BIFAP database can be used to identify women suffering from miscarriages, which will serve to further study risk factors associated with miscarriages with special attention to drug utilization.
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spelling doaj.art-33e140446c194e73ab6bf60012e2c2fa2023-11-21T20:10:07ZengMDPI AGHealthcare2227-90322021-05-019559610.3390/healthcare9050596A Validation Study on the Frequency and Natural History of Miscarriages Using the Spanish Primary Care Database BIFAPSara Sanchez Ortiz0Consuelo Huerta1Ana Llorente-García2Paloma Ortega3Paloma Astasio4Lucía Cea-Soriano5Department of Preventive Medicine and Public Health, Faculty of Medicine, Complutense University of Madrid, 28040 Madrid, SpainDepartment of Preventive Medicine and Public Health, Faculty of Medicine, Complutense University of Madrid, 28040 Madrid, SpainBIFAP, Division of Pharmacoepidemiology and Pharmacovigilance, Spanish Agency for Medicines and Medical Devices (AEMPS), 28040 Madrid, SpainDepartment of Preventive Medicine and Public Health, Faculty of Medicine, Complutense University of Madrid, 28040 Madrid, SpainDepartment of Preventive Medicine and Public Health, Faculty of Medicine, Complutense University of Madrid, 28040 Madrid, SpainDepartment of Preventive Medicine and Public Health, Faculty of Medicine, Complutense University of Madrid, 28040 Madrid, Spain(1) Background: There is a major gap of knowledge towards the natural history of miscarriages in electronic medical records. We aimed to calculate the frequency of miscarriages using data from BIFAP database. (2) Methods: We identified all pregnancy losses and carried out a multistep validation exercise. Potential cases with positive predictive values (PPV) of miscarriage confirmation <85% or those confirming other pregnancy loss were excluded. Kaplan–Meier figures and incidence rates (IRs) of miscarriage with 95% confidence intervals (CIs) expressed by 1000 person-weeks were calculated. Stratifying analysis by age, specific high-risk groups, and drug exposure within the pre-pregnancy period were performed restricted to women with recording last menstrual period (LMP). (3) Results: Women with confirmed miscarriage (<i>N</i> = 18,070), tended to be older, with higher frequency of comorbidities and drug utilization. Restricting to women with LPM recorded, IR of miscarriage was 10.89 (CI 95% 10.68–11.10) per 1000 women-weeks, with a median follow-up of 10 weeks (IQR: 8–12). The IR according to age was: 2.71 (CI 95% 2.59–2.84) in those aged <30 years compared to 9.11 (CI 95% 8.55–9.70) in women aged ≥40 years. Advanced maternal age (Hazard Ratio (HR, 95% confidence interval) CI 95%: 3.34 (3.08–3.62)), use of antihypertensives (1.49 (1.21–1.84), and use of drugs classified as D or X during pregnancy (1.17 (1.07–1.29)) showed to be positive predictors associated with increased risk of miscarriages. (4) Conclusion: BIFAP database can be used to identify women suffering from miscarriages, which will serve to further study risk factors associated with miscarriages with special attention to drug utilization.https://www.mdpi.com/2227-9032/9/5/596validation studiespregnancyprimary care databasesmiscarriagesrisk factors
spellingShingle Sara Sanchez Ortiz
Consuelo Huerta
Ana Llorente-García
Paloma Ortega
Paloma Astasio
Lucía Cea-Soriano
A Validation Study on the Frequency and Natural History of Miscarriages Using the Spanish Primary Care Database BIFAP
Healthcare
validation studies
pregnancy
primary care databases
miscarriages
risk factors
title A Validation Study on the Frequency and Natural History of Miscarriages Using the Spanish Primary Care Database BIFAP
title_full A Validation Study on the Frequency and Natural History of Miscarriages Using the Spanish Primary Care Database BIFAP
title_fullStr A Validation Study on the Frequency and Natural History of Miscarriages Using the Spanish Primary Care Database BIFAP
title_full_unstemmed A Validation Study on the Frequency and Natural History of Miscarriages Using the Spanish Primary Care Database BIFAP
title_short A Validation Study on the Frequency and Natural History of Miscarriages Using the Spanish Primary Care Database BIFAP
title_sort validation study on the frequency and natural history of miscarriages using the spanish primary care database bifap
topic validation studies
pregnancy
primary care databases
miscarriages
risk factors
url https://www.mdpi.com/2227-9032/9/5/596
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