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Volume 68 Issue 1, Pages 66 - 71 © 2007 The Authors Journal compilation © 2007 Blackwell
Publishing Ltd
ORIGINAL ARTICLE Pregnancy outcomes following cabergoline treatment: extended
results from a 12-year observational study Annamaria Colao*, Roger Abs†, David González Bárcena‡,
Philippe Chanson§, Wolfgang Paulus¶ and David L. Kleinberg**
*Department of Molecular and Clinical Endocrinology and Oncology, Section of
Endocrinology, University Federico II of Naples, Naples, Italy,
†Department of Endocrinology, University Hospital Antwerp, Edegem, Belgium,
‡Department of Endocrinology, UMAE, Centro Médico Nacional la Raza IMSS,
Mexico,
§Department of Endocrinology, Assistance Publique-Hôpitaux de Paris, Hôpital
de Bicêtre and University Paris-Sud 11, Le Kremlin-Bicêtre, France,
¶Institute of Reproductive Toxicology, St Elisabeth Hospital (Academic Teaching
Hospital of the University of Ulm), Ravensburg, Germany and
**Neuroendocrine Unit, Department of Medicine, New York University School of
Medicine, New York, NY, USA Correspondence: Annamaria Colao, Department of Molecular and
Clinical Endocrinology and Oncology, Section of Endocrinology, University
Federico II of Naples, via S. Pansini 5, 80131 Naples, Italy.
Tel.: +39 081 7462132; Fax: +39 081 5465443;
E-mail: colao@unina.it
ABSTRACT Objective Cabergoline
is a dopamine agonist used to treat hyperprolactinaemia. Because
hyperprolactinaemia is a significant cause of infertility in women,
cabergoline and other dopamine agonists are frequently prescribed to reduce
prolactin levels and restore normal menses. They are usually discontinued
shortly after the patient becomes pregnant. Although cabergoline has been
used to treat hyperprolactinaemia since the mid-1990s, safety data related to
maternal and foetal exposure to this agent are still limited. Design The
current prospective, observational study reports on a total of 380
pregnancies. This extends by 154 pregnancies the results of a previously
published interim report on the outcomes of 226 pregnancies in women treated
with cabergoline up to 1994. Main
outcome measures Outcomes examined include the incidence
of abortions and premature delivery and the number and types of foetal
malformations or abnormalities. Results Follow-up
data were available for 329 pregnancies, including 258 (78%) deliveries
and 71 (22%) abortions. Of the 71 reported abortions, 31 (44%) were
voluntary, 30 (42%) were spontaneous miscarriages, and nine (13%)
were therapeutic. Of the 258 deliveries, 250 (97%) were live deliveries,
four (2%) were stillbirths, and the status of delivery was unknown for
the remaining four (2%). Of the 250 live deliveries, 193 (77%) were
term deliveries (gestational period > 37 weeks), 45 (18%)
were preterm deliveries (gestational period ≤ 37 weeks), and 62% of
the infants had normal birthweights (i.e. 3–4 kg). Neonatal
abnormalities were recorded for 23 (9%) of the infants with no apparent
pattern in type or severity. Conclusion The results of this study suggest
that foetal exposure to cabergoline through early pregnancy does not induce
any increase in the risk of miscarriage or foetal malformation.
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