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Archives of Gynecology and Obstetrics
Published in: Archives of Gynecology and Obstetrics 2/2016

01-08-2016 | Maternal-Fetal Medicine

Diclofenac/misoprostol during early pregnancy and the risk of miscarriage: a Danish nationwide cohort study

Authors: Jon T. Andersen, Dimitrios Mastrogiannis, Nadia L. Andersen, Morten Petersen, Kasper Broedbaek, Vanja Cejvanovic, Torben K. Nielsen, Henrik E. Poulsen, Espen Jimenez-Solem

Published in: Archives of Gynecology and Obstetrics | Issue 2/2016

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Abstract

Introduction

Misoprostol can be used in the prevention of gastric ulcer in treatment with diclofenac and is used in rheumatic diseases. Since misoprostol causes contractions of the uterus, it can also be used to induce abortions when administrated vaginally. The aim of the study was to investigate if early pregnancy exposure to oral diclofenac/misoprostol was associated with miscarriage.

Method

We conducted a nationwide cohort study identifying all registered pregnancies in Denmark from 1997 to 2011. All births were identified using the Medical Birth Registry, and all records of induced abortion and miscarriage were from the National Hospital Register. Data on drug use were from the National Prescription Register. Cox proportional hazard regression models were used to calculate the hazard of miscarriage in women exposed to diclofenac/misoprostol in early pregnancy.

Result

We identified 1,338,824 pregnancies (970,491 births, 142,147 miscarriages, 226,145 induced abortions). One hundred sixty-six were exposed to diclofenac/misoprostol in the early pregnancy of which 28.3 % (47) ended up in a miscarriage compared to 10.6 % among unexposed. The adjusted hazard ratio of having a miscarriage after exposure to diclofenac/misoprostol in the first trimester was 3.6 (CI 95 % 2.6–4.9).

Conclusion

We found an increased risk of miscarriage after exposure to diclofenac/misoprostol during the early pregnancy. Women in the fertile age should not be treated with the combination of diclofenac/misoprostol if other options were available.
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Metadata
Title
Diclofenac/misoprostol during early pregnancy and the risk of miscarriage: a Danish nationwide cohort study
Authors
Jon T. Andersen
Dimitrios Mastrogiannis
Nadia L. Andersen
Morten Petersen
Kasper Broedbaek
Vanja Cejvanovic
Torben K. Nielsen
Henrik E. Poulsen
Espen Jimenez-Solem
Publication date
01-08-2016
Publisher
Springer Berlin Heidelberg
Published in
Archives of Gynecology and Obstetrics / Issue 2/2016
Print ISSN: 0932-0067
Electronic ISSN: 1432-0711
DOI
https://doi.org/10.1007/s00404-015-3966-9

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