Effect of early postpartum use of the contraceptive implants, NORPLANT, on the serum levels of immunoglobulins of the mothers and their breastfed infants.

Ten breastfeeding women had the contraceptive implants NORPLANT inserted between days 30 and 39 postpartum. The immunoglobulins IgG, IgM and IgA were measured in the serum of the mothers and the infants before insertion and five months later. A control group of breastfeeding mothers who did not use any contraception or used local barrier methods were similarly studied. Although there were changes in the immunoglobulin levels with time in both mothers and infants, there were no group differences; this indicates that the use of NORPLANT does not influence these factors of humoral immunity.

PIP: This study measured major immunoglobulin levels in the serum of 10 breastfeeding mothers and their infants before insertion of the Norplant contraceptive implant (at 30-39 days postpartum) and again 5 months after insertion. 10 women who were also breastfeeding but either used no contraception or used barrier methods (diaphragm or condom) served as controls. Comparison of preinsertion and postinsertion mean serum concentrations revealed a significant rise in IgG and a significant decline in IgM in both groups of mothers. IgA concentrations declined after 6 months postpartum in both the study and control groups, but the difference was statistically significant only for women in the Norplant group. There were no significant differences between the 2 groups in changes occurring after 5 months. Similarly, there were no group differences, either at study admission or after 5 months, in the immunoglobulins of infants of Norplant-using women and controls. Overall, the changes in maternal and infant immunoglobulin levels noted in this study are similar to those expected during parturition and infancy. These results provide no evidence that use of hormonal contraception in the immediate postpartum period can make both mothers and infants more susceptible to infection. It is noted, however, that immunoglobulin levels are only 1 aspect of the immune system.

Effect of subdermal levonorgestrel contraceptive implants, Norplant, on liver functions.

Forty-seven normal health women were studied longitudinally for changes in liver functions during the use of the levonorgestrel contraceptive implant system, NORPLANT. Samples were collected before insertion of the implants and after one, three and six months of use. The enzymes studied were the transaminases (SGOT and SGPT), alkaline phosphatase and gamma-glutamyl transferase. Serum bilirubin and bile acid levels were also measured. The protein synthetic function of the liver was tested by estimation of total proteins, albumin, transferrin, hemopexin, ceruloplasmin and haptoglobin. The three main immunoglobulins, G, M and A, were also measured. There were no significant changes in the liver enzymes after NORPLANT use. Serum bilirubin and bile acid concentrations showed rises in the first month of use which ameliorated in subsequent months. Serum albumin was transiently increased during the first and third months. Ceruloplasmin decreased significantly at the sixth month. The concentrations of total serum proteins and the other individual proteins showed no significant change. The results point to safety of NORPLANT implant use, as regards hepatic functions.

Effect of subdermal levonorgestrel contraceptive implants, Norplant, on serum lipids.

Forty-seven normal non-smoking parous women were enrolled in a longitudinal study of the effect of use of the subdermal levonorgestrel implants, NORPLANT, on serum lipids. Blood samples were collected after an overnight fast before insertion and after three, six, nine and twelve months of use. The high-density lipoprotein cholesterol showed no change until the twelfth month when it was increased (P less than .05). Total cholesterol, low-density lipoprotein cholesterol and triglyceride levels decreased significantly during NORPLANT use.

Effect of levonorgestrel contraceptive implants, Norplant, on blood coagulation.

A longitudinal study of coagulation parameters was carried out on 47 women using the levonorgestrel subdermal implants, NORPLANT. The study comprised measurement of platelet count, prothrombin time, thrombin time, partial thromboplastin time with kaolin, clotting factors I, II, V and VI through XIII, plasminogen, antithrombin III (AT III), alpha 1 antitrypsin, alpha 2 macroglobulin and fibrinogen degradation products. The tests were done at admission and after one, three and six months of NORPLANT use. Parallel and similar studies were done on two groups of oral contraceptive users; the first group used a pill containing 1 mg norethisterone and 50 micrograms mestranol, and the second a pill consisting of 150 micrograms levonorgestrel and 30 micrograms ethinylestradiol. Results from this ongoing study have indicated that women using NORPLANT implants evidenced lack of effects on most of the parameters tested except for factor VII activity which was increased and AT III concentration which was decreased after six months of use. The combined pill users evidenced marked changes in the platelet count, the screening tests and in most of the coagulation-promoting factors; the changes were apparent after three months of use and became more pronounced after six months. The results demonstrate, with marked contrast, that the implants had less pronounced effects on the blood coagulation system than did the combined pills used in this study.

PIP: The effect of Norplant, a subdermal contraceptive implant containing levonorgestrel, on blood coagulation factors was investigated in 47 healthy women. Coagulation parameters were also measured in 55 subjects who were taking combination type oral contraceptives (OCs) (either a pill containing 1 mg norethisterone and 50 mcg mestranol or a preparation containing 150 mcg levonorgestrel and 30 mcg ethinyl estradiol). Blood sampling was carried out at admission and after 1, 3, and 6 months of contraceptive use. Parameters measured included platelet count, prothrombin time, thrombin time, partial thromboplastin time with kaolin, clotting factors I, II, V, and VI-XIII, plasminogen, antithrombin III, alpha 1 antitrypsin, alpha 2 macroglobulin, and fibrinogen degradation products. Norplant users showed a lack of effect on the factors tested, except for factor VII activity, which was increased, and antithrombin III concentration, which was decreased after 3 months of use. In contrast, the combined OC users evidenced marked changes in platelet count, the screening tests, and most coagulation promoting factors. These changes became more pronounced after 6 months. Women taking the levonorgestrel-ethinyl estradiol OC evidenced less pronounced changes in some coagulation parameters than those taking the norethisterone-mestranol preparation; however, the high dropout rate among OC users limits the conclusions that can be drawn from these results. These results point to a relative lack of effect of Norplant implants on the blood coagulation-fibrinolytic system, presumably due to the absence of estrogen and the low dose of progestogen delivered to the body.

Sex steroids in women with liver cirrhosis.

Eighteen women with hepatic cirrhosis were examined for plasma levels of testosterone, estrone, estradiol, progesterone and sex hormone binding globulin. For eight who were amenorrheic, with advanced liver cirrhosis and ascites, the reduction of testosterone and rise in estrone and sex hormone binding globulin concentrations were significant. Plasma extradiol and progesterone were lower than normal levels, but the differences were not statistically significant. The other ten patients were menstruating (mostly irregularly), and their hormonal levels were assessed in different states of their cycles. All of them did not ovulate, had low levels of plasma progesterone and also showed consistent estrone concentration excess relative to estradiol and significant lowering of testosterone and elevation of sex hormone binding globulin. These findings are compared with previous reports on males with liver cirrhosis.

Behaviour of hepatitis B antigen in bilharzial patients infected with HBs positive viral hepatitis.

A TOTAL of 204 cases with acute viral hepatitis were studied: 93 bilharzial and 111 non-bilharzial. This study is concerned with the 106 cases showing positive HBS Ag test. Follow up of the cases after discharge from the Fever Hospital was carried out by repeated clinical and laboratory examinations 3 montly in the first year and 6 monthly subsequently. The bilharzial and non-bilharzial patients were found to be equally susceptible to HBS Ag positive hepatitis (p=0.25). However, antigenaemia tended to last longer as a whole in the bilharzial patients (p=0. 005) and was not affected by successful specific antibilharzial treatment. It seems that bilharzial infection predisposes to "retention" of HBs antigen, after subsidance of the acute attack, thus increasing the volume of reservoir for HB virus in our rural community.