Hormonal Pregnancy Tests Research Articles

EXOGENOUS HORMONES AND OTHER DRUG EXPOSURES OF CHILDREN WITH CONGENITAL HEART DISEASE1

A history of oral contraceptive use, hormonal pregnancy tests, prescribed hormones and other drugs was obtained from 390 mothers of infants with congenital heart disease and 1254 mothers of normal infants in Massachusetts. The data show a small positive association between estrogen/progesterone exposure and cardiac malformation, the prevalence ratio estimate of exposed to non-exposed being 1.5 (90 per cent confidence limits are 1.0, 2.1). No association was evident, however, between hormones and trunco-conal or any other class of defect among the cases, an observation which casts doubt on a causal relationship betweem hormones and cardiovascular malformations. Several other drugs were reported more frequently by cases' mothers. These include: ampicillin; aspirin; a combined anti-nausea agent (doxylamine succinate, dicyclomine hydrochloride and pyridoxine hydrochloride); chlordiazopoxide, codeine, diazepam, diphenylhydantoin; insulin; phenobarbital; phenothiazine; phenylephrine; and tetracycline.

Continued use of hormonal pregnancy test.

In both 1975 and 1977, the Committee on Safety of Medicines reported an association between hormonal pregnancy tests (HPTs) and subsequent congenital abnormalities and stated that such tests should no longer be used. Despite these findings, the Secretary of State declined to ban the proprietary drug involved (Primodos). Following the 1977 warning, 600 consecutive abortion patients at 6 branches of the British Pregnancy Advisory Service (BPAS) were asked whether they had been given HPTs. 12 patients (2%) indicated they had received such tests. Since most women had not consulted a general practitioner before coming to BPAS, this figure is probably an underestimate of actual use. Although a few doctors may have prescribed an HPT in the belief that the pregnancy would be terminated anyway, some HPTs were administered by doctors who subsequently refused to refer the patient for an abortion. If banning Primodos is considered an unacceptable infringement of professional freedom, the Department of Health and Social Security should consider making it a controlled drug, with the requirement that physicians ascertain through an immunological test that the recipient is not pregnant.

Maternal drug histories and congenital abnormalities.

We obtained drug histories for the first trimester of pregnancy for 836 mothers of congenitally malformed babies and for an equal number of control mothers of normal babies from the same doctors' practices. There was an association between the use of a hormonal pregnancy test and the subsequent birht of a malformed baby. There was also a greater use of barbiturates by mothers of affected children compared with mothers of control babies, mainly accounted for by treatment of epileptic mothers with phenobarbitone. For all other drugs usage was similar in both sets of mothers.

Congenital heart disease and prenatal exposure to exogenous sex hormones.

One-hundred and four infants with congenital heart disease were identified from their birth certificates and matched with normal controls. Their gestational histories were examined to see whether they had been exposed to exogenous sex hormones. Exposure was 8-5 times more common among the infants with malformations than among controls. A history of hormone exposure was more common among those patients with multiple malformations, and the exposed infants were also more likely to have died (and to have died earlier) than those who had not been exposed, which suggests that hormone exposure causes severe types of malformations. The commonest type of exposure was to hormone pregnancy tests, which was needless exposure. Only two of the mothers of malformed infants had inadvertently used oral contraceptives in the first trimester.

HORMONAL PREGNANCY TESTS

Medical Journal of AustraliaVolume 1, Issue 3 p. 46-47 Comment HORMONAL PREGNANCY TESTS First published: 01 January 1977 https://doi.org/10.5694/j.1326-5377.1977.tb130498.xCitations: 1AboutPDF ToolsRequest permissionExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Share a linkShare onFacebookTwitterLinkedInRedditWechat No abstract is available for this article.Citing Literature Volume1, Issue3January 1977Pages 46-47 RelatedInformation

Hormonal pregnancy tests and congenital malformations.

I have read with interest Dr. D.T. Janerich's article (April 23, p. 1058) confirming the teratological effect of hormonal pregnancy tests and other exogenous sex hormone preparations in relation to congenital heart diseases. The discovery of the teratological effect of hormonal pregnancy tests emerged from my studies into central nervous system malformations in 1967. In this and in further publications on this topic, the teratogenic potential of hormonal pregnancy tests has always been referred to as "congenital malformations," without specifying the type but mentioning that the observation was made on spina bifida cases as my study then included only this particular malformation. The analogous effect between hormonal pregnancy tests and the use of other exogenous sex hormone preparations in early pregnancy has been emphasized in all the above communications. I am pleased that subsequent studies have confirmed my observation in different types of birth defects. The large variety of malformations reported by the above workers seems to be a clear indication that the teratogenic effect of hormonal pregnancy tests and other exogenous sex hormones is not specific but rather depends on the stage of fetal development when the insult occurs - probably a similar mode of action to that of many other powerful teratogens. Therefore it would be more prudent to adhere to the above conventional teratological principle instead of using acronyms such as the VACTREL syndrome (after Nora and Nora) which might lead to confusion.

Letter: Hormonal pregnancy tests and congenital malformations.

Letter: Hormonal pregnancy tests and congenital malformations.

Letter: Hormonal pregnancy tests and congenital malformations.

Letter: Hormonal pregnancy tests and congenital malformations.

Letter: Hormonal pregnancy tests and congenital malformations.

Letter: Hormonal pregnancy tests and congenital malformations.

Editorial: Can the pill cause birth defects?

Potential establishment of a causal relationship between a syndrome of multiple congenital anomalies (vertebral, anal, cardiac, tracheoesophageal, renal, and limb, i.e., "VACTERL") and maternal progesterone/estrogen exposure has been made by retrospective and prospective studies. A study providing etiologic evidence between oral contraceptives and birth defects (limb anomalies especially) found only males affected; the proportion of males in another cluster of VACTERL pa tients was also very high (10 out of 15). It was suggested that if oral contraceptives are teratogenic, it is with people who are predisposed. Unlike thalidomide, there is no high risk at each exposure but there are a high number of exposures from widespread use. The importance of eliciting accurate drug exposure histories from mothers is streesed; only 1/3 of the patients who had established exposure to oral contraceptives at a vulnerable embryonic period had this exposure recorded in their charts. It was concluded that hormonal pregnancy tests should be stopped.

Hormonal pregnancy tests and spina bifida.

GAL1 has suggested that hormonal pregnancy tests may be teratogenic to the developing central nervous system. In a study of 100 mothers of spina bifida cases she found nineteen of these mothers had had a hormonal pregnancy test (‘Amenorone Forte’ or ‘Primodos’) compared with four of 100 “matched” control mothers. Laurence2 has criticized Gal's findings on two counts: (1) the choice of controls, and (2) the possibility of finding a difference this great by chance when a number of epidemiologic factors are studied.

Risks and benefits of the use of hormonal pregnancy test tablets.

IN a preliminary communication we suggested1 the possible teratogenic effect of hormonal pregnancy tests but a recent epidemiological study2 failed to confirm the findings. In view of the conflicting results and the practical implications of further use of this test, it seems to be important to give a full account of the unpublished data on which our suggestions were based, and to give a brief summary of other findings.

Reply to Gal

GAL claims to have implicated hormonal pregnancy test tablets as one of the causes of neural tube malformations. These contain high doses of oestrogens and tend to be administered when one would expect the embryo to be most susceptible. Although on immediate inspection of her evidence, 19 tests in pregnancies ending in central nervous system malformations, with only 4 tests in matched controls, might be reason for casting suspicion on these hormone tests, a note of caution should be sounded. First, the choice of controls was unfortunate for while index cases were drawn from a wide area of Southern England, matched controls were chosen from women attending one hospital only. The difference found could be due entirely to local differences in prescribing practices. Indeed, that the controls were perhaps inappropriate in other respects too is suggested by another study by Gal and her co-workers1 when in an investigation into the possible role of Vitamin A deficiency in the genesis of central nervous system malformation, a significant relationship was demonstrated when the self-same controls were used, which all but disappeared when controls were selected from the individual hospitals where the malformed child was born. Second, it is well known in epidemiological studies that when a number of different factors are related to a medical event that one or more may be related at say a 1 in 100 level of significance. The suggested relationship should, however, always be re-examined by a second run before it is accepted. Both these objections are underlined by a study of the hormone tests in South Wales by Laurence and his co-workers (ref. 2 and personal communication) where on the one hand it was noted that practitioners in one area but not in another frequently used the test, and on the other hand, that no significant difference between the test frequency in index and control pregnancies was found, and were thus unable to confirm Gal's findings. In any case, epidemiological data during the last 30 years would not be in accordance with such an aetiology for the neural tube abnormalities.

Hormonal pregnancy tests and neural tube malformations.

IN 1967 Gal, Kirman and Stern1 reported a possible relationship between pregnancy tests using pills containing synthetic oestrogenic and progesterogenic hormones and the birth of a child with spina bifida. Of the 100 mothers of children with spina bifida, nineteen gave a history of pregnancy diagnosis by this means; only four of the 100 matched control mothers gave such a history.

Hormonal pregnancy tests and congenital malformation.

DURING a survey of babies born with meningomyelocele or hydrocephalus, one hundred mothers of such children provided histories of the relevant pregnancy. Among other things they were questioned by one of us (I. G.) as to the drugs which they had taken. The same information was obtained from a matched control group of one hundred mothers recently delivered of healthy babies. Data obtained from the mothers about drugs during pregnancy were checked with the medical advisers. As part of the survey the mothers were asked how their pregnancy was diagnosed. Nineteen mothers in the survey group and four of the control mothers reported having received oral tablets for the diagnosis of pregnancy (Table 1). There was no significant difference between the two groups with respect to any other drugs taken in the first trimester. The average interval between conception and test was 5.6 weeks in the survey group, and 6.2 weeks in the control group.

The ectopic choriocarcinoma

1.1. Choriocarcinoma is a very malignant and rapidly fatal tumor.2.2. Excessive vaginal bleeding, and lesions of the vagina, lungs, and liver, especially following a recent pregnancy, should suggest the possibility of a chorionepithelioma.3.3. Most of the cases can be diagnosed by biopsy, x-ray, history, clinical findings, and hormonal pregnancy tests.4.4. These methods of diagnosis should be used routinely, especially after the hydatidiform mole.5.5. When the diagnosis is made early, and only a solitary lesion is present, surgery offers some hope in prolonging the patient's life.6.6. If in the early stage the lesion is in a less malignant phase, early recognition and treatment may offer a better prognosis.