ArticleClinical research in cardiology : official journal of the German Cardiac Society2016
Pregnancy outcome after exposure to the novel oral anticoagulant rivaroxaban in women at suspected risk for thromboembolic events: a case series from the German Embryotox Pharmacovigilance Centre.
Article in Clinical research in cardiology : official journal of the German Cardiac Society, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 21 papers, 2 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
21 citing papers in PubMed, 2 syntheses or guidelines pooled it, 70 citations in OpenAlex.
- 2023 ACC/AHA/ACCP/HRS Guideline for the Diagnosis and Management of Atrial Fibrillation: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines.Journal of the American College of Cardiology · 2024Guideline
- Guideline
- 2025 Thai guideline for the diagnosis and management of atrial fibrillation.Asian biomedicine : research, reviews and news · 2025Article
- A Saudi Heart Association Position Statement on the use of DOACs in Patients With Arterial and Venous Thrombosis.Journal of the Saudi Heart Association · 2025Article
- Special Considerations for Women of Reproductive Age on Anticoagulation.Journal of general internal medicine · 2022Review
- Pulmonary Embolism and Pregnancy-Challenges in Diagnostic and Therapeutic Decisions in High-Risk Patients.Frontiers in cardiovascular medicine · 2022Review
- Management of pregnant patients with pulmonary arterial hypertension.Frontiers in cardiovascular medicine · 2022Review
- Women and atrial fibrillation.Journal of cardiovascular electrophysiology · 2021Review
- Review
- Reproductive issues in women on direct oral anticoagulants.Research and practice in thrombosis and haemostasis · 2021Article
- Management of tachyarrhythmias in pregnancy - A review.Obstetric medicine · 2020Review
- Brazilian Cardiology Society Statement for Management of Pregnancy and Family Planning in Women with Heart Disease - 2020.Arquivos brasileiros de cardiologia · 2020Article
- Role of pregnancy hormones and hormonal interaction on the maternal cardiovascular system: a literature review.Clinical research in cardiology : official journal of the German Cardiac Society · 2019Review
- Pregnancy outcome after first trimester use of angiotensin AT1 receptor blockers: an observational cohort study.Clinical research in cardiology : official journal of the German Cardiac Society · 2018Observational
- Management of Venous Thromboembolism in Pregnancy.Current treatment options in cardiovascular medicine · 2018Review
- Valvular Heart Disease and Pregnancy.Current treatment options in cardiovascular medicine · 2018Review
- Drug safety in pregnancy: the German Embryotox institute.European journal of clinical pharmacology · 2018Article
- Evidence Gaps in the Era of Non-Vitamin K Oral Anticoagulants.Journal of the American Heart Association · 2018Review
- Challenges of Anticoagulation Therapy in Pregnancy.Current treatment options in cardiovascular medicine · 2017Review
- [Pharmacovigilance in Germany : It is about time].Der Internist · 2016Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundNew oral anticoagulants are increasingly used in women of childbearing age, but apart from one case report there is no published experience with rivaroxaban exposure during pregnancy.
methodsFrom October 2008 to December 2014, the German Embryotox Pharmacovigilance Centre identified 63 exposed pregnancies among 94 requests concerning rivaroxaban use during childbearing age. Follow-up included paediatric checks until 6 weeks after birth.
resultsAll pregnancies with completed follow-up were exposed at least during the first trimester. Treatment indications included venous thromboembolism, knee surgery, and atrial fibrillation. 37 pregnancies were prospectively ascertained and resulted in six spontaneous abortions, eight elective terminations of pregnancy, and 23 live births. All women had discontinued rivaroxaban after recognition of pregnancy, mostly in the first trimester, but in one woman treatment continued until gestational week 26. There was one major malformation (conotruncal cardiac defect) among the 37 prospectively ascertained pregnancies in a woman with complex medication and a previous foetus with cardiac malformation without exposure to rivaroxaban. Only one case of bleeding concerning a retrospective report of surgery for missed abortion was observed in our case series.
conclusionOur results might give reassurance to those women, who were inadvertently exposed to rivaroxaban in early pregnancy. However, our limited cohort size does not allow ruling out an increased malformation risk and does not support the use of rivaroxaban during pregnancy. In all cases of (inadvertent) rivaroxaban exposure during 1st trimester, anticoagulation regimen should be reconsidered and a detailed ultrasound assessment recommended to confirm normal foetal development.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.