Endocrine Abstracts

Recombinant human growth hormone (GH) is not indicated for use during pregnancy and in women of childbearing potential not using contraception. Nonetheless, in clinical practice, some women taking GH replacement conceive during treatment and many continue GH during their pregnancy. Here we report data on GH-treated women enrolled in two complementary, international, non-interventional registry studies, NordiNet IOS (NCT00960128; 2006–2016) and ANSWER (NCT01009905; 2002–2016), that assessed effectiveness and safety of real-life treatment with Norditropin (somatropin).

Patient information was entered at routine clinic visits by participating physicians using a web-based system. Overall, 54 pregnancies were reported in 40 female patients with GH deficiency (GHD): 28 women had one pregnancy, 10 had two and two had three pregnancies. Median (range) age at estimated conception date was 31.9 (23.0–41.8) years. Pituitary disease aetiology included pituitary/hypothalamic tumours/adenomas in 27.5%, craniopharyngioma in 12.5%, idiopathic/congenital in 25.0% and other causes of acquired GHD in 30.0%. Seven patients had isolated GHD. Twenty-four (60.0%) patients had adult-onset GHD and 14 (35.0%) had childhood-onset GHD (missing, n = 2). At baseline, 27.5% of patients reported one additional pituitary hormone deficiency, 10.0% had two, 17.5% had three, 20.0% had four, 2.5% had five and 5.0% had six. Deficiency of LH/FSH was present in 50.0%, TSH in 42.5%, ACTH in 35.0% and ADH in 12.5% of patients at conception. Seven (17.5%) patients had diabetes insipidus. GH dose (mg/day) at conception was >0.6 in 20 (37.0%) pregnancies, 0.4–0.6 in nine (16.7%) and ≤ 0.4 in six (11.1%). In seven (13.0%) pregnancies GH therapy was stopped by conception, permanently discontinued/stopped before study inclusion in two (3.7%), and patient was not treated in two (3.7%) (missing, n = 8). During pregnancy, GH therapy was stopped (≤5 months/before conception) in 27 (50.0%) pregnancies, partially continued (> 5 – < 7 months) in two (3.7%) and continued in 16 (29.6%) pregnancies (no treatment, n = 3; missing, n = 9). Among the 18 pregnancies with continued/partially-continued GH therapy, mean daily dose was >0.6 mg in 10, 0.4–0.6 mg in six and ≤ 0.4 in two. Forty-two (77.8%) pregnancies resulted in the birth of a healthy child; no birth defects were reported. There were five (9.3%) spontaneous abortions and two elective terminations (patient wish, n = 1; medical indication, n = 1). Outcome was unknown for five pregnancies.

In these women, most pregnancies resulted in the birth of healthy children. These data add to available knowledge on the outcome of pregnancy in GH-treated women with GHD.