Pregnancy & Lactation : הריון/הנקה

4.6   Fertility, pregnancy and lactation

Given the lack of adequate teratogenic studies in humans, glucocorticoids can only be administered during pregnancy, breast-feeding and in women of fertile age after having thoroughly evaluated the health benefits and potential risks of these medications for the mother, the embryo or the fetus.

Pregnancy

When prenatal corticotherapy is indicated, the advantages and disadvantages need to be weighed and the clinical benefit compared to the side effects (including the inhibition of growth and the increased risk of infection).

In some cases it is necessary to continue the corticosteroid treatment during pregnancy or even increase the dose (e.g., in replacement corticotherapy).

Intramuscular administration of betamethasone induces a significant decrease in the frequency of dyspnea in the fetus when the product is administered more than 24 hours before delivery (before the 32nd week of gestation).

Published data show that the prophylactic use of corticosteroids after the 32nd week of pregnancy is still controversial. Therefore, the physician should weigh the benefits and potential risks for the mother and fetus when using corticosteroids after the 32nd week of pregnancy.

Corticosteroids are not indicated to treat hyaline membrane disease after birth.

In prophylactic treatment of hyaline membrane disease in premature infants, do not administer corticosteroids to pregnant women with preeclampsia or eclampsia or with signs of placental lesions.

Children born to mothers given high doses of corticosteroids during pregnancy should be carefully monitored to detect any signs of adrenal insufficiency.

When betamethasone injections have been administered to mothers before birth, infants show a transient inhibition of fetal growth hormone and presumably of the pituitary hormones that regulate the production of steroids, both in the definitive zones and fetal zones of the fetal adrenals. However, inhibition of fetal hydrocortisone has not interfered with the pituitary-adrenal responses to stress after birth.

As corticosteroids readily cross the placenta, newborns and infants born to mothers who received corticosteroids during most or part of their pregnancy should be subject to careful examination in order to detect a possible, though very rare, congenital cataract.

Women who received corticosteroids during pregnancy should be monitored during and after contractions and during childbirth to detect adrenal insufficiency due to the stress caused by birth.

Studies have shown an increased risk of neonatal hypoglycaemia following antenatal administration of a short course of betamethasone to women at risk for late preterm delivery.
Breastfeeding
Corticosteroids cross the placental barrier and are excreted in breast milk.

Given that Diprospan may induce adverse reactions in breast-fed infants, a decision must be made whether to stop breast-feeding or stop the medicinal product, taking into account the importance of the medicinal product for the mother.