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PubMed1992

Medical records in litigation: the Dalkon Shield story.

The Dalkon Shield was manufactured by A.H. Robins Inc. in the early and mid seventies, before it was withdrawn from sale because of the influx of lawsuits against the manufacturers. The case has become the largest tort case in history, with approximately 200,000 claimants worldwide and will not be wound up for years to come. Slater and Gordon is an Australian firm of solicitors with offices in three states. They have the largest Dalkon Shield practice in the world and represent almost 3,000 claimants. One of their most difficult tasks in preparing the cases is the gathering of medical evidence to substantiate claimants' assertions. This entails collecting relevant medical records from across the country and around the world going back almost twenty years for almost 2,000 women. The project has magnified the importance of accurate and complete documentation, kept intact and made accessible. The influence of medical record administrators is highlighted.

Australia↗
PubMed1976

The heterocytotoxicity of human serum. III. Studies of the serum levels and distribution of activity in human populations.

A metabolic inhibition assay has been employed to investigate the distribution of serum heterocytotoxicity mediated by natural antibody activating the classical complement pathway and by antibody-independent activation of the alternative complement pathway in human serum samples derived from various groups of individuals. Levels in female cancer patients and in women taking oral contraceptives were significantly elevated over normal controls. Newborn infants exhibited approximately half of the average adult levels. Levels were maximally elevated in patients with visceral cancer, particularly in individuals with adenocarcinomas, while patients with sarcomas exhibited reduced levels. These and other data derived from the literature suggest that the metabolic inhibition assay may provide a useful measure of natural antibody and activation of the alternate complement pathway representative of mechanisms of natural immunity vs tumours.

Adult↗
PubMed1986

Body fluid volumes in rats with mestranol-induced hypertension.

Because estrogens have been reported to produce sodium retention, this study investigated the possibility that hypertension in rats resulting from the ingestion of an estrogen used as an oral contraceptive could be due to increases in body fluid volumes. Female rats were given feed containing mestranol for 1, 3, and 6 mo; control rats were given the feed without mestranol. The mestranol-treated rats had higher arterial pressures than the controls only after 6 mo of treatment. Plasma volume, extracellular fluid volume, and total body water were measured in each rat by the distribution volumes of radioiodinated serum albumin, 35SO4, and tritiated water, respectively. Values for blood volume, interstitial fluid volume, and intracellular fluid volume were derived from these measurements. These body fluid volumes, expressed per 100 g of body weight, were not different between the mestranol-treated rats and their controls at any of the three treatment times. Due to differences in body weight and lean body mass between the mestranol-treated and the control rats, these volumes also were expressed per 100 g of lean body mass. Again, no differences were observed between the mestranol-treated rats and the control rats for any of these body fluid compartments at any of the treatment times. These studies, therefore, were unable to provide evidence that increases in body fluid volumes contributed to the elevated arterial pressure in this rat model of oral contraceptive hypertension.

Animals↗
PubMed2001

[A study of relationship between oral contraceptives and gene polymorphism and types of stroke].

OBJECTIVE: To evaluate the relationship between combined oral contraceptives (COC) taking and differential types of stroke, together with the role of the susceptive genetic factors associated with the onset of stroke in women using pills. METHODS: Case-case study was used. A total of 111 female patients with stroke were selected and with questionnaires filled in and blood samples collected. The distributions of coagulative factor V Leiden mutation (G1691-->A), prothrombin gene mutation (G20210-->A) and angiotensin converting enzyme (ACE) gene insertion/deletion(I/D) polymorphism were observed. Differences of genetic and nongenetic risk factors between hemorrhagic and ischaemic stroke were compared. RESULTS: Women using pills had a higher risk developing hemorrhagic than ischaemic stroke (OR = 3.03, P < 0.05), comparing with those never used pills. The strength of association between body mass index (BMI) > or = 24 kg/m2 and ischaemic stroke was much greater than it between BMI and hemorrhagic stroke (OR = 2.99, P < 0.05). No mutation of G1691-->A or G20210-->A was found. The deletion allele frequency of ACE gene was slightly higher in ischaemic stroke group, but with no statistic significance. CONCLUSION: The results suggested that possible association existed between the use of COC and the onset of hemorrhagic stroke, however the mutations of G1691-->A in factor V gene, G20210-->A in prothrombin gene and I/D polymorphism of ACE gene did not seem to contribute to this association.

China↗
PubMed1998

Pharmacokinetics of etonogestrel released from the contraceptive implant Implanon.

Eight healthy women between 22 and 40 years of age participated in this prospective open study of 2 years' duration. Either on or between days 1 to 7 of a spontaneous menses, an intravenous bolus dose of 150 micrograms etonogestrel (3-ketodesogestrel) was given. During days 1-5 of a subsequent spontaneous cycle, the single-rod contraceptive implant (Implanon) was inserted in the upper arm of the volunteer. One year after placement of the implant, another intravenous bolus dose was given (implant in place), and a third bolus dose was given after 2 years, with the implant removed. Frequent serum sampling immediately after the intravenous dosings of etonogestrel was done to study the primary pharmacokinetic parameters, i.e., volume of distribution and clearance, allowing the calculation of the absorption rate and bioavailability of the implant, as a function of time. Results showed that etonogestrel released from Implanon has an absorption rate of approximately 60 micrograms/day after 3 months, which slowly decreases to 30 micrograms/day at the end of 2 years. The bioavailability over this period of time was constant and close to 100%. The clearance remained around 7.5 L/h. With a bioavailability and clearance that remained constant, it may be concluded that there is no accumulation of etonogestrel.

Absorption↗
PubMed1983

Influence of acetaminophen-induced hepatic necrosis on the pharmacokinetics of levonorgestrel.

The pharmacokinetics of levonorgestrel in control mice and in mice with induced hepatic necrosis were investigated. Hepatic necrosis was induced by fasting mice for 18 hr and then giving the acetaminophen in a dose of 750 mg/kg i.p. Measurement by radioimmunoassay of plasma levonorgestrel has been used to compare the pharmacokinetic parameters of the drug after oral and intravenous administration in both control and liver-affected animals. The pharmacokinetic parameters of levonorgestrel in control mice showed some similarity to those observed in human subjects, save the systemic bioavailability which was about 67% in mice compared to 100% in humans. The animals with induced hepatic necrosis compared with controls showed: 1 - Similar mean plasma levels; 2 - Increased metabolic clearance; 3 - Shortened elimination half-life; and 4 - No change in volume of distribution, half-life of distribution and systemic bioavailability. The reasons for any change have been discussed and interpreted.

Acetaminophen↗
PubMed1999

A retrospective study on the clinical presentation and treatment outcome of melasma in a tertiary dermatological referral centre in Singapore.

BACKGROUND: This is a retrospective study on the epidemiology of 205 patients with melasma seen in a tertiary dermatological referral centre in Singapore. PATIENTS: The mean age of the 205 patients with melasma was 42.3 years with a female preponderance of 21:1 female to male ratio. There were proportionally more Chinese with melasma than the other races compared to the racial distribution of patients attending our clinic. Ninety percent of our patients had skin type III or IV. The mean age of onset of melasma was 37.6 years. Most sought treatment only 5 years after the appearance of their melasma. Forty-six percent of melasma were light brown, the majority of which were distributed on the malar areas (89%). More than 2/3 had epidermal melasma. Eighty-eight percent had mild localised melasma (occurring on < 20% of the total facial area). Only 26.8% of our patients reported sun exposure, 25 (12.1%) reported pregnancy and 27 (13.1%) reported oral contraceptives as precipitating factors. A positive family history of melasma was observed in 21 (10.2%) patients. Sunscreen forms the backbone in the treatment of melasma in our patients. Most patients were prescribed a sunscreen together with hydroquinone containing bleaching cream (54%) as first line treatment. Patients with epidermal type of melasma responded slightly better to treatment than those with dermal type of melasma (28% experienced > 25% reduction in pigmentation compared to 16% respectively (n.s.)). CONCLUSION: Overall, 53% of our patients experienced some reduction of pigmentation with 28% experiencing > 25% reduction and 7% experiencing > 75% reduction. In 40%, the pigmentation remained stable with treatment. Treatment of melasma remains an enigma. More studies need to be undertaken to improve treatment response to alleviate the psychosocial impact melasma has on the patient.

Adult↗
PubMed1995

A model for estimating the potency and survival of human gametes in vivo.

Sperm and ova are sensitive to numerous toxicants in animal studies; however, human vulnerability has been far more difficult to assess, due in part to a lack of methods for measuring the viable survival of human gametes in vivo. We present a parametric model for fertility, which assumes that the viable lifetime of the ovum is fixed while that of sperm is exponentially distributed. By reducing the number of parameters that must be estimated, compared to a previous approach, the model leads to improved tests for differences in sperm and egg survival between exposed and unexposed couples. Since it assumes that batches of sperm introduced on different days present independent competing "risks" (of fertilization) to the ovum, the model also provides for estimation of the age distribution, in days, of the sperm which actually fertilized the ova. This allows us to consider whether older sperm are more likely to produce defective embryos. We apply this model to data from a group of women who were intensively studied, beginning when they discontinued contraception in order to start a pregnancy. Participants kept daily records of intercourse. Daily urine specimens allowed the day of ovulation to be estimated and conceptions to be identified, based on assays of excreted hormones. Applying the parametric model to these data, the estimated mean viable lifetime for sperm is 1.4 days, while the lifetime of the ovum appears to be less than a day.(ABSTRACT TRUNCATED AT 250 WORDS)

Cell Survival↗
PubMed1993

Long-term recall of time-to-pregnancy.

OBJECTIVE: To validate two versions of a short self-completion questionnaire on time-to-pregnancy. DESIGN: Information from the questionnaire was compared with concurrently collected data from the same individuals. POPULATION: Questionnaires were sent to 1,647 women who continue to be followed up by the Oxford Family Planning Association Contraceptive Study. Replies were received from 1,498, a response rate of 91.0%. Successful matching was achieved with 1,392 pregnancies that met the study criteria and that had values of time-to-pregnancy in both data sources. Median recall time was 14 years (interquartile range, 11 to 16 years). MAIN OUTCOME MEASURES: At the group level, the frequency distributions of time-to-pregnancy from the two sources are presented as cumulative percentages. At the individual level, the distribution of discrepancies between the sources is tabulated separately for each value of time-to-pregnancy, and accuracy of detection of clinical subfertility is presented (sensitivity and specificity). RESULTS: At the group level, remarkably good agreement was found between the two sources of information. Digit preference was present to a limited degree. There were no important differences between the two questionnaire versions. At the individual level, some misclassification was evident. For the detection of clinical infertility, sensitivity was 79.9% and specificity was 94.9%. CONCLUSIONS: Short, self-completion questionnaires are remarkably accurate for assessing time-to-pregnancy at a group level. Individual-level misclassification is frequent, but detection of clinical subfertility is fairly accurate.

Adult↗
PubMedDate not supplied

Union status, marital history and female contraceptive sterilization in the United States.

CONTEXT: Much of what is known about the choice of sterilization as a contraceptive method is based on data from married women or couples. Because of increasing rates of cohabitation, divorce and repartnering, however, the relationship context in which sterilization decisions are made has changed. METHODS: The 1995 National Survey of Family Growth includes the complete birth and union histories of 10,277 white, black and Hispanic women. The distribution of union status and marital history at the time of tubal sterilization was estimated for these three racial and ethnic groups among the 799 women who had had a tubal ligation in 1990-1995 before age 40. Cox proportional hazard regression models were used to estimate the effects of union status and marital history on the risk of tubal sterilization. The analysis controlled for the woman's age, parity, race and ethnicity education, region, experience of an unwanted birth and calendar period. RESULTS: Among women who obtained a tubal sterilization, most whites (79%) and Hispanics (66%) were married when they had the operation, compared with only 36% of black women. At the time of their sterilization, 46% of black women had never been married. Among all women, regardless of race and ethnicity and net of all controls, the probability of tubal sterilization is about 25% lower for single, never-married women than for cohabiting or married women. Cohabitation does not reduce the likelihood in comparison to marriage, however. Higher rates of tubal sterilization among Hispanic women are accounted for by their higher parity at each age; differences in parity or marriage by race only partially account for the relatively higher rates of tubal sterilization among black women. CONCLUSIONS: Because women currently spend greater proportions of their lives outside of marriage or in less-stable cohabiting partnerships than they did in the past, they are increasingly likely to make the decision to seek sterilization on their own. As a result, the gender gap in contraceptive sterilization will likely increase. The possibility of partnership change is an important consideration in choosing sterilization as a contraceptive method.

Adolescent↗
PubMed2003

Pharmacokinetic interaction of tetracycline with centchroman in healthy female volunteers.

OBJECTIVES: We aimed to investigate the effect of tetracycline coadministration, with and without lactic acid bacillus spores supplementation, on the pharmacokinetics of centchroman, a nonsteroidal oral contraceptive, in healthy female volunteers. PARTICIPANTS AND METHODS: The study was a single-centre, single-blinded, randomised, parallel treatment study in healthy female subjects of reproductive age randomised to two groups (11 subjects in each group). On day 1, subjects were given either a single oral dose of centchroman 30 mg with tetracycline 250 mg (group A) or a single dose of centchroman 30 mg, tetracycline 250 mg and one tablet containing 60 million lactic acid bacillus spores (group B). Tetracycline (250 mg three times daily) and lactic acid bacillus spores (one tablet three times daily) were continued for 3 days. Serial blood samples were collected and analysed by high performance liquid chromatography. The pharmacokinetic parameters were compared with the control data reported previously from this laboratory. RESULTS: Coadministration of tetracycline yielded significantly higher maximum plasma concentrations (C(max)) [35%] and a shorter time to reach C(max) (t(max)) values for centchroman (42%) than those obtained in the control group of females (p < 0.05). Inclusion of lactic acid bacillus spores in the regimen resulted in similar effects with increased C(max) (47%) and area under the concentration-time curve from time zero to infinity (34%) of centchroman (p < 0.05) with a significant decrease in t(max). Other parameters such as half-life, apparent clearance, apparent volume of distribution and mean residence time of centchroman were not affected by either of the treatments. CONCLUSIONS: The apparent effects of either of the regimens on centchroman pharmacokinetics seem to be of little clinical relevance in terms of increased rate or extent of availability. It can be concluded that this tetracycline-containing regimen is unlikely to alter the contraceptive efficacy of centchroman in humans.

Administration, Oral↗
PubMed1988

The permanent effect of reproductive events on blood prolactin levels and its relation to breast cancer risk: a population study of postmenopausal women.

In each of two population-based studies conducted on the Island of Guernsey between 1967-1976 and 1977-1984, respectively, single specimens of blood were taken from over 5000 normal women. From these two studies there were 1173 and 946 postmenopausal women in whom blood prolactin was determined and multivariate analysis was used to establish the association between blood prolactin concentration and possible determinants of risk of breast cancer. Since prolactin levels were log-normally distributed these analyses were done on log-transformed data. The age at menarche or menopause, age at first or last childbirth, length of reproductive life (i.e. time from menarche to menopause) or post-menopausal life (i.e. time from menopause to time of blood sampling), contraceptive use and history of breast cancer were not significantly associated with blood prolactin concentration. Of significance were age, parity, time of blood sampling and assay drift. Ponderosity (Quetelet's Index) was positively associated with prolactin concentration and this was significant using a one-tail criterion. Women with a mammographic pattern designated DY by Wolfe had significantly higher prolactin levels than those with N1 patterns. However, the main finding to emerge was that after standardizing for all the other variables increasing parity was related to a step-wise reduction in blood prolactin levels. Since this had occurred in women who had had their last child up to 35 years previously it implies this effect is permanent. It could therefore be that the protective effect on breast cancer risk of multiparity and early first pregnancy could be mediated by such a life-long reduction in blood prolactin levels.

Age Factors↗
PubMed1997

Fertilization antigen-1: cDNA cloning, testis-specific expression, and immunocontraceptive effects.

cDNA encoding for a sperm antigen, designated fertilization antigen (FA-1), was cloned and sequenced from murine testis cDNA-lambdagt11 expression library using FA-1 mAb. Computer-generated translation analysis of 649-bp cDNA yielded an ORF of 164 amino acids with the first ATG Met start codon at nucleotide 81 and the stop codon TAA at nucleotide 577 and a polyadenylylation tail following the stop codon. The translated protein has a calculated molecular mass of 18.2 kDa and a potential N-linked glycosylation site at amino acids 158-160, besides at least two O-linked glycosylation sites. The hydropathy plot generated from the deduced amino acid sequence indicated it to be a membrane-anchored peptide. Extensive computer search in the GenBank, National Biomedical Research Foundation, and Swiss sequence banks did not identify any known nucleotide/amino acid sequence having homology with FA-1 cDNA or deduced amino acids, indicating it to be a novel protein. Northern blot analysis and reverse transcription-PCR indicated testis-specific expression of FA-1 antigen. The FA-1 cDNA was subcloned into pGEX-2T vector and expressed in glutathione S-transferase gene fusion system to obtain the recombinant protein. The recombinant protein specifically reacted with ZP3 of oocyte zona pellucida and its affinity-purified antibodies completely blocked sperm-zona pellucida interaction in mice. These findings suggest that the sperm-specific recombinant FA-1 antigen is an attractive candidate for the development of a contraceptive vaccine.

Amino Acid Sequence↗
PubMed1995

Terminations of pregnancy for exposure to oral retinoids in South Australia, 1985-1993.

The oral retinoids, isotretinoin and etretinate, are highly teratogenic drugs which have been available in Australia since 1985 because of their unique effectiveness in severe cystic acne, psoriasis and other keratinization disorders. Only dermatologists can prescribe them, but in spite of strict guidelines by the manufacturers and the College of Dermatologists, exposed pregnancies have occurred. We attempted to determine the circumstances of exposure to these drugs for the 18 pregnancies terminated in South Australia in 1985-1993, using questionnaires to medical practitioners who notified the terminations under legislation. The main reason for their occurrence was the lack of compliance with the use of effective contraception by the women. In South Australia, some prescriptions of oral retinoids by unauthorized doctors have been dispensed during this period. Using statistics on prescriptions dispensed, an estimate was made of 1 termination of pregnancy for 319 courses of treatment for women with isotretinoin. Extension of guidelines for prescription and more detailed counselling in relation to the use of contraception are recommended. It is also suggested that doctors intending to recommend terminations obtain consent to discuss exposure with the dermatologists concerned, who may not be aware of the exposed pregnancy.

Abortion, Induced↗
PubMed1987

The right to have a second birth given up.

The Government of the Wendeng County, Shandong Province has taken measures to carry out the family planning program in a down-to-earth way. For the past few years, there are 2141 couples who have given up, of their own accord, the right to have a 2nd birth, though they are entitled to have. During the practice of family planning, the Wendeng Government started with the publicity of family planning policies. More than 30,000 copies of publicity pamphlets were distributed and about 220 shows of videotapes, films and slides were played in the countryside. The county's Family Planning Committee and the Maternal and Child Health Care Station, together with other departments concerned gave 120 lectures on birth control in the rural areas and sent contraceptives to every village with guidance to households. For the past 3 years, the proportion of women at childbearing age using contraceptives has increased by 62%.

Asia↗