Outcome of 100 pregnancies initiated under treatment with cabergoline in hyperprolactinaemic women.

CONTEXT: Data concerning the safety for pregnancy of cabergoline treatment in hyperprolactinaemic women are still scarce.
OBJECTIVE: To exclude a higher than normal risk for miscarriage and congenital malformation in pregnancies initiated under cabergoline treatment.
DESIGN: A retrospective study of 100 pregnancies in 72 hyperprolactinaemic women treated with cabergoline at the time of conception and follow-up of the 88 newborn children.
METHODS: Cabergoline was interrupted in 99 pregnancies and continued in one case. Foetal exposure dose to cabergoline was calculated for each pregnancy. Complications of pregnancy and neonatal status were compared to those observed in an age-and delivery time-matched control group of 163 women.
RESULTS: The mean foetal exposure dose to cabergoline was 3.6 +/- 4.7 mg. The rate of spontaneous miscarriages was 10%. Three medical terminations of pregnancy were performed for a foetal malformation (3%). Minor to moderate complications were observed in 31% of the pregnancies, a figure similar to that found in the control group. An increase in tumour size (2-8 mm) was observed in 17/37 evaluated cases, needing reintroduction of cabergoline during pregnancy in five patients. The 84 deliveries resulted in 88 infants, three of them presenting with a malformation (3.4%). Neonatal status was comparable to the control group, where a malformation rate of 6.3% was observed. Postnatal development of the children was normal.
CONCLUSION: Cabergoline treatment at the time of conception appears to be safe for both the pregnancy and the neonate, although more data are still needed on a larger number of pregnancies.