Pregnancy outcomes following cabergoline treatment: extended results from a 12-year observational study.
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.


METHODS
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.


METHODS
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 < or = 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.


CONCLUSIONS
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.
Colao
Annamaria
A
Department of Molecular and Clinical Endocrinology and Oncology, Section of Endocrinology, University Federico II of Naples, Naples, Italy. colao@unina.it
Abs
Roger
R
Bárcena
David González
DG
Chanson
Philippe
P
Paulus
Wolfgang
W
Kleinberg
David L
DL
D000022:Abortion, Spontaneous / Q000139:chemically induced; D000077465:Cabergoline; D018491:Dopamine Agonists / Q000009:adverse effects* / Q000627:therapeutic use; D004873:Ergolines / Q000009:adverse effects* / Q000627:therapeutic use; D005260:Female; D006801:Humans; D006966:Hyperprolactinemia / Q000188:drug therapy; D011247:Pregnancy; D011256:Pregnancy Outcome; D011446:Prospective Studies
D018491:Dopamine Agonists; D004873:Ergolines; D000077465:Cabergoline