Risk of adverse birth outcome and miscarriage in pregnant users of non-steroidal anti-inflammatory drugs: population based observational study and case-control study
British Medical Journal 2001;322:266-270 3feb01
Gunnar Lauge Nielsen, consultant, a Henrik Toft Sørensen, associate professor, b Helle Larsen, research fellow, d Lars Pedersen, biostatistician. c
a Department of Medicine, Odder Hospital, DK-8300 Odder, Denmark, b Department of Clinical Epidemiology and Medicine V, Aalborg and Aarhus University Hospitals, DK-8000 Aarhus C, Denmark, c Danish Epidemiology Science Centre, Institute of Epidemiology and Social Medicine, DK-8000 Aarhus C, d Department of Obstetrics and Gynaecology and Medicine M, Aalborg Hospital, DK-9000 Aalborg, Denmark
Correspondence to: G L Nielsen uxgln@aas.nja.dk
Objective: To estimate the risk of adverse
birth outcome in women who take non-steroidal anti-inflammatory drugs
during pregnancy.
Design and setting: Population based cohort study and a case-control
study, both based on data from a prescription registry, the Danish birth
registry, and one county's hospital discharge registry.
Participants: Cohort study: 1462 pregnant women who had taken
up prescriptions for non-steroidal anti-inflammatory drugs in the
period from 30 days before conception to birth and 17 259 pregnant
women who were not prescribed any drugs during pregnancy. Case-control
study: 4268 women who had miscarriages, of whom 63 had
taken non-steroidal anti-inflammatory drugs, and 29 750 primiparous controls
who had live births.
Main outcome measures: Incidences of congenital abnormality, low birth
weight, preterm birth, and miscarriage.
Results: Odds ratios for congenital abnormality, low birth
weight, and preterm birth among women who took up prescriptions for
non-steroidal anti-inflammatory drugs were 1.27 (95% confidence interval
0.93 to 1.75), 0.79 (0.45 to 1.38), and 1.05 (0.80 to
1.39) respectively. Odds ratios for the taking up of prescriptions in
the weeks before miscarriage ranged from 6.99 (2.75 to 17.74) when
prescriptions were taken up during the last week before the miscarriage
to 2.69 (1.81 to 4.00) when taken up between 7 and 9 weeks
before. The risk estimates were no different when the analysis was
restricted to missed abortions.
Conclusions: Use of non-steroidal anti-inflammatory drugs during
pregnancy does not seem to increase the risk of adverse birth outcome
but is associated with increased risk of miscarriage.
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