Evaluation of fertility regulating methods in women.
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Biomedical subjects
Publications and source records attributed to K Prema.
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Plasma alpha-feto protein (AFP) levels were measured by radioimmunoassay in 73 women using oral contraceptive pills for varying durations of time. The levels were significantly higher at 6 months of pill use and tended to return to normal after 12 months. In none of the women was plasma AFP higher than 25 ng/ml which is considered to be indicative of liver damage.
There has been a growing awareness of possible alterations in the trace element profiles of hormonal contraceptive users and their consequences. A study of serum copper and zinc levels in users of combined estrogen-progestogen contraceptives and in users of injectable progestogen was undertaken. Use of combined estrogen-progestogen contraceptives resulted in a significant decrease in serum zinc levels within 3 days and an increase in serum copper levels within 10 days. In users of combined estrogen-progestogen contraceptives the magnitude and time of occurrence of the decrease in zinc levels and the increase in copper levels was unaltered by chemical composition, dosage, route of administration, and duration of use beyond 3 months. With injectable progestogen (norethindrone enanthate, 20 mg/month), a significant decrease in serum zinc levels occurred within 24 hours after injection. Serum copper levels were not altered. With injectable progestogen, the type of drug, the dosage, and the duration of use beyond the 1st month had no effect on the magnitude of the decrease in serum zinc levels.
A study was undertaken to determine whether long-term use of a copper intrauterine device (IUD) was associated with any alteration in the serum copper levels and thereby whether absorption of copper from the device in utero could result in copper toxicity. Serial estimations in copper IUD wearers showed that there was no alteration in serum copper levels for a period of up to 24 months. The mean range and frequency distribution of serum copper levels in long-term copper IUD wearers was similar to that seen in the normal population. There was no difference in the mean 24-hour urinary copper excretion between the control group and the copper IUD wearers. Data suggest that the copper released from a copper IUD may not be readily absorbed from the uterine fluid. This hypothesis needs verification.
Plasma tocopherol (vitamin E), cholesterol and triglycerides were estimated to normal non pregnant women and in women throughout pregnancy. All three constituents were increased in the later stages of pregnancy. There was a significant statistical correlation between tocopherol and cholesterol levels, but not between the vitamin and triglycerides. The data suggest that the increase in tocopherol may be associated with a corresponding increase in cholesterol since both are known to share a common transport system, but the association was evident only during pregnancy. Compared to controls, plasma vitamin E levels were not altered in pre-eclampsia nor in oral contraceptive users.
Levels of tocopherol, cholesterol and triglycerides were estimated in paired maternal and umbilical cord plasma samples. All three constituents were significantly lower in cord plasma than in maternal plasma. Since tocopherol and lipid share a common lipoprotein carrier system, the present data suggests that the reduction observed in cord circulation could be due to the inability of the fetus to synthesise these carrier proteins. There was no relation between maternal vitamin E concentrations and infant birth weights.
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Pharmacokinetics of norethindrone (NET) was evaluated in eleven women belonging to a low socio-economic group and in five womem belonging to the high socio-economic group after the administration of an oral dose of 0.35 mg NET minipill on an empty stomach. Blood samples were collected at different intervals of time over a period of 24 hours. Plasma NET was estimated by radioimmunoassay. In all women, peak levels of NET occurred within 1-2 hours and a semi-log plot of plasma NET levels showed a biexponential decline. The half-life of plasma NET clearance was relatively shorter in women of low socio-economic group with poor nutritional status as indicated by anthropometric indices, as compared to that in well nourished women of high socio-economic group. There was a significant positive correlation between weight/(height) 2x 100 index on the one hand and t1/2 (beta) on the other in all the women studied, thereby suggesting a role for nutritional status in the metabolic handling of NET.
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The effect of the use of an oral contraceptive on the frequency of sister-chromatid exchanges (SCEs) was investigated. Oral contraceptive users showed significantly higher mean SCE per cell compared with both normal and pregnant women. This result obviously means an increased mutagenic environment in these cells--due either to the pill itself or to a metabolite(s).
Some of the parameters of immune status-percentage of B and T lymphocyte subpopulation, PHA-induced lymphocyte transformation measured by 3H-thymidine incorporation (PILT) and levels of total haemolytic complement (CH5O) were studied in Indian women from low income group who were using estrogen-progestogen combination pills. There were no differences in percentage of B and T lymphocyte subpopulation or PILT between OC users and the control group. However, CH5O levels were significantly lower in OC users. The depression in circulating complement levels in OC users is intriguing and suggests the possibility that complement system and circulating immune complexes may be altered in OC users.