Дипроспан и 1-й триместр беременности

[dr_medvedev]

Женщина уколола "от аллергии" дипроспан не зная, что беременна
FDA относит бетаметазон к категории Д в 1-м триместре. Куча информации о побочных эффектах для плода во 2 и 3-м триместрах. По 1-му ничего не нашел

Я рекомендую пациентке прервать беременность учитывая категорию риска и пролонгированную форму препарата, но настаивать не могу, учитывая отсутствие четких медицинских показаний.

Подскажите насколько высок риск аномалий плода в этой ситуации? Женщина хочет сохранить беременность.

[dr_medvedev]

Всем спасибо. Уже отабортировались....

[Dobro]

Betamethasone is classified FDA pregnancy risk category C. Complications, including cleft palate, still birth, and premature abortion, have been reported when systemic corticosteroids were administered during pregnancy. If these drugs must be used during pregnancy, the potential risks should be discussed with the patient. Infants born to women receiving large doses of systemic corticosteroids during pregnancy should be monitored for signs of adrenal insufficiency, and appropriate therapy should be initiated, if necessary. Topical corticosteroids should not be used in large amounts, on large areas, or for prolonged periods of time in pregnant women. (Harrison's)

[Dobro]

Teratogen newsletter

Corticosteroids in pregnancy
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General Studies
Although various types of corticosteroids are available, few studies have looked at the teratogenic potential of each one separately. Most of the studies analyzed the various drugs together, making it difficult to assess the teratogenic risk for a specific medication. In addition, women are often prescribed corticosteroids as part of a regimen of various medication combinations, so there may be some synergistic effect that is difficult to ascertain. While there have been mixed findings in regards to oral clefting, available studies do not suggest an overall increase in malformations after in utero exposure to corticosteroids. In published cases, the rate of malformations for therapeutic corticosteroid use was 4.4% (Roubenoff et al, 1988). No cleft palate defects were noted in 26 babies exposed to high doses of prednisone throughout pregnancy for treatment of maternal lupus (Fine et al, 1981). The Michigan Medicaid surveyed newborns exposed to prednisone (N=236), prednisolone (N=143), and methylprednisone (N=222). The data found no association between corticosteroid use and congenital defects, except perhaps for prednisolone, which had a 7.7% incidence for total number of birth defects. No cases of oral clefting were reported (Briggs et al, 1998). Fraser and Sajoo (1995) surveyed the available literature from 1952-1994 and found 457 exposed patients, in which the frequency of malformations was 3.5%. Although single case reports may reflect reporting bias, the two cases of cleft palate observed was higher than the 0.2 cases expected, and a possible association could not be excluded.


Betamethasone (Diprosone, Celestone)
Betamethasone is a synthetic corticosteroid used to promote fetal lung maturation in the third trimester, and is also found in some topical preparations. Since betamethasone is an isomer of dexamethasone, the information on dexamethasone may also be relevant.
Betamethasone, like all the other glucocorticoids, has been associated with clefting in mice, rats, and rabbits, but it is also associated with an increased incidence of omphalocele and umbilical hernia in rats (Mosier et al, 1982; Ishimura et al, 1975). These studies show decreased cell number in the lung, and impaired myelination and cellular development of the central nervous system, as well as suppression of the immune system (MacArthur et al, 1981).
Several studies have followed prematurely-born children whose mothers were given betamethasone as part of a randomized, placebo control trial (MacArthur et al, 1981; Schmand et al, 1990; Doyle et al, 1989). No difference between placebo and steroid groups existed in cognitive or psychological development, and in physical growth. Schmand et al. (1990) found an increased number of hospital admissions due to infectious diseases in early childhood, possibly demonstrating some proof of immune system suppression in offspring due to antenatal betamethasone exposure. In one study, betamethasone was shown to mildly constrict the ductus arteriosus, but the findings were not clinically significant (Wasserstrum et al, 1989). In general, there seems to be no long-term side effects of betamethasone use in the third trimester. Like dexamethasone, betamethasone is typically not suggested for treatment of maternal disease; no studies have been reported to evaluate the risks of its use during the first and second trimesters.

[Dobro]

EARLY PREGNANCY:
Biology and Medicine
Editor-in-Chief: Eytan R. Barnea MD, FACOG

[Ссылки доступны только зарегистрированным пользователям ]

The effect produced by a teratogenic agent depends upon the fetal developmental stage at time of exposure. Several important phases in human development are recognized:

The pre-organogenetic phase, from conception until somite formation known as the "all or none" period, when insults to the embryo are likely to result in death of the conceptus and miscarriage (or resorption) or in intact survival (Fabro, 1986). At this stage, the embryo is undifferentiated and repair and recovery are possible through multiplication of the still totipotential cells to replace those, which have been lost. Exposure of embryos to teratogens during the pre-somitic stage usually does not cause congenital malformations (Moore, 1998), unless the agent persists in the body beyond this period.

The embryonic period, from 18 to 60 days after conception is the period when the basic steps in organogenesis occur. This is the period of maximum sensitivity to teratogenicity since not only are tissues differentiating rapidly but also damage to them becomes irreparable. Exposure to teratogenic agents during this period has the greatest likelihood of causing a structural anomaly. Since teratogens are capable of affecting many organ systems, the pattern of anomalies produced depends upon which systems are differentiating at the time of teratogenic exposure.

The fetal phase, from the end of the embryonic stage to term, is the period when growth and functional maturation of organs and systems already formed occur. Exposure to teratogens in this period will mainly affect fetal growth causing intrauterine growth retardation or macrosomia, the size of a specific organ, or the function of the organ. They will rarely cause gross structural anomalies, except for the brain which may be affected almost throughout the entire pregnancy.