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Article

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

1
Department of Preventive Medicine and Public Health, Faculty of Medicine, Complutense University of Madrid, 28040 Madrid, Spain
2
BIFAP, Division of Pharmacoepidemiology and Pharmacovigilance, Spanish Agency for Medicines and Medical Devices (AEMPS), 28040 Madrid, Spain
*
Author to whom correspondence should be addressed.
Academic Editor: Stefano Restaino
Healthcare 2021, 9(5), 596; https://doi.org/10.3390/healthcare9050596
Received: 14 April 2021 / Revised: 13 May 2021 / Accepted: 14 May 2021 / Published: 18 May 2021
(This article belongs to the Special Issue Diagnosis and Treatment for Women's Health)
(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 (N = 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. View Full-Text
Keywords: validation studies; pregnancy; primary care databases; miscarriages; risk factors validation studies; pregnancy; primary care databases; miscarriages; risk factors
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MDPI and ACS Style

Sanchez Ortiz, S.; Huerta, C.; Llorente-García, A.; Ortega, P.; Astasio, P.; Cea-Soriano, L. A Validation Study on the Frequency and Natural History of Miscarriages Using the Spanish Primary Care Database BIFAP. Healthcare 2021, 9, 596. https://doi.org/10.3390/healthcare9050596

AMA Style

Sanchez Ortiz S, Huerta C, Llorente-García A, Ortega P, Astasio P, Cea-Soriano L. A Validation Study on the Frequency and Natural History of Miscarriages Using the Spanish Primary Care Database BIFAP. Healthcare. 2021; 9(5):596. https://doi.org/10.3390/healthcare9050596

Chicago/Turabian Style

Sanchez Ortiz, Sara, Consuelo Huerta, Ana Llorente-García, Paloma Ortega, Paloma Astasio, and Lucía Cea-Soriano. 2021. "A Validation Study on the Frequency and Natural History of Miscarriages Using the Spanish Primary Care Database BIFAP" Healthcare 9, no. 5: 596. https://doi.org/10.3390/healthcare9050596

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