Hosam T. Salem

Sonographic assessment of ovarian and endometrial changes during long-term Norplant use and their correlation with hormonal levels*

OBJECTIVE To study the probability of ovulation and subclinical abortion during long-term use of Norplant and to assess the concomitant endometrial development. DESIGN This was a prospective nonrandomized comparative study. The ovaries and endometrium were assessed daily by ultrasonography during 59 menstrual cycles in 50 women who were using Norplant for > 1 year. Serum concentrations of E2, P, FSH, LH, pregnancy specific beta 1 glycoprotein (Sp1), and hCG were also daily measured. The findings were compared with those in 35 ovulatory cycles in normal fertile women not using contraception. SETTING Clients of the Family Planning Clinic of Assiut University Hospital (Norplant users) and the hospital women staff (controls). RESULTS Sonographic and hormonal evidence of ovulation were observed in one third of Norplant users; two of them resulted in conception. However, the majority of these ovulatory cycles showed low midcycle peaks of E2, FSH, and LH and evidence of luteal phase defect (LPD). Excessive follicular enlargement was observed in 46% of the cycles. Norplant users had significantly thinner endometrium that did not exhibit the normal phasic changes in sonographic texture. Apart from conceptive cycles, no rise in Sp1 or hCG was observed. CONCLUSIONS Norplant acts mainly by inhibiting ovulation, but when this occurs, it is associated with LPD and subnormal endometrial development. Subclinical abortion does not contribute to the contraceptive effect.

Multicenter clinical trial on the efficacy and acceptability of a single contraceptive implant of nomegestrol acetate, Uniplant

Uniplant, a single Silastic implant containing nomegestrol acetate, provides contraceptive efficacy for one year. Uniplant use for one year was studied in 1,803 healthy women of reproductive age, enrolled from 10 centers in 9 countries, after informed consent. Implants were placed subdermally either in the upper arm or in the gluteal region. Two-hundred-seventy-six subjects discontinued prior to completing one year of study. Cumulative discontinuation rate at 12 months was 15.72%. Medical reasons for discontinuation were principally menstrual-related. Fifteen pregnancies occurred during the one year study period, resulting in a 12-month net cumulative pregnancy rate of 0.94%. Approximately 56% of subjects using Uniplant had bleeding patterns similar to normal menstruation. Results from this study confirm that Uniplant is an efficient, well tolerated, 12-month contraceptive implant, with the advantage of easier insertion and removal of the single implant compared to other multiple implant methods.

Influence of levonorgestrel contraceptive implants, NORPLANTR, initiated early postpartum upon lactation and infant growth

This study was undertaken to investigate the effect of use of levonorgestrel contraceptive implants, NORPLANT, by breastfeeding mothers on lactational performance and infant growth. NORPLANT implants were inserted between days 30 and 42 postpartum in 50 lactating women. Two control groups of breastfeeding mothers, 50 each, were studied in parallel: the first used an intrauterine device (Cu T380-Ag) and the second used either barrier or no contraception. There was no difference in lactational performance among the three groups. The increments in infant weight and height in the three groups were within the normal range for Egyptian infants. However, the rates of weight and height gain in the early postpartum months were slightly, but significantly, lower in the NORPLANT group than in the two control groups. However, by the sixth postpartum month, there were no significant group differences in these growth parameters. The possible confusing effect of supplementary feeding is discussed.

Prognostic value of biochemical tests in the assessment of fetal outcome in threatened abortion

Maternal concentrations of serum progesterone, oestradiol, chorionic gonadotrophin, Schwangerschaftsprotein 1 and placental protein 5 were measured in 67 patients with threatened abortion. The levels of all biochemical variables were significantly reduced in those patients who had an unfavourable outcome. The clinical efficiency of each of these tests was very similar.

The use of nomegestrol acetate subdermal contraceptive implant, uniplant, during lactation

Uniplant is a single contraceptive implant intended for one year use. It contains the progestogen nomegestrol acetate. The clinical performance and the effect of its use during the first postpartum year on breastfeeding performance and growth and health of the infants were studied and compared to the findings in a parallel group who used an intrauterine contraceptive device (IUD) in a prospective, non-randomized study. This was carried out in Assiut, Egypt. Two-hundred-forty fully breastfeeding mothers asking for initiation of contraception early postpartum were assigned according to their choices into either nomegestrol subdermal contraceptive implant (Uniplant) (120 women) or intrauterine contraceptive device (CuT 380A) (120 women). The mother and infant pairs were followed up at monthly intervals during the first three months and at two-month intervals thereafter up until the first birthday of the baby. No pregnancy occurred in the two groups. Amenorrhea was significantly more prolonged in the Uniplant group than in the IUD group. There were no significant differences in net continuation rates between the two groups (88.3 versus 92.4 per 100 women, respectively). There were no significant differences between the two groups in the number of breastfeeding episodes, time of weaning, and the cumulative rates of full and partial breastfeeding. There were no significant differences between the two groups in infant weight, weight gain per day, or in infant linear growth. There were no significant differences in the incidence of important health problems affecting the infants of the two groups. However, there were seven infant deaths, six of them were in the Uniplant group. Uniplant subdermal contraceptive implants can be offered as a new contraceptive option suitable for nursing mothers.

Acceptability of injectable contraceptives in Assiut, Egypt

The present work was a randomized comparative study of two injectable progestogen-only contraceptives. The first group (200 subjects) received 150 mg of depotmedroxyprogesterone acetate (Depoprovera) every 84 +/- 7 days and the second (200 subjects) received 200 mg of norethisterone enanthate (Noristerat) every 56 +/- 7 days. Acceptors of injectable contraceptives in Assiut, Egypt, were mainly women looking for fertility termination. Menstrual disruption was the main side effect among both treatment groups. Amenorrhoea was the commonest menstrual complaint and was the main reason for discontinuation in both groups. Only one pregnancy occurred during NET-EN use; two more pregnancies occurred, one in each of the two groups but there were indications that conception preceded the first injection. Menstrual irregularities were generally more frequent with DMPA users. However, DMPA had better one-year continuation rates than NET-EN (68.8 +/- 3.5 and 57.1 +/- 3.6 per 100 women, respectively).

Levonorgestrel concentrations in maternal and infant serum during use of subdermal levonorgestrel contraceptive implants Norplant by nursing mothers.

The transfer of levonorgestrel to infants was studied in 42 lactating women in whom the contraceptive subdermal implants, Norplant, were inserted 30 to 40 days postpartum. The women breastfed their infants for one year. Simultaneous mother and infant blood samples were taken once during the year. The levonorgestrel serum concentrations were measured by radioimmunoassay. During the first postinsertion month, the levonorgestrel concentration in the infants serum amounted, on the average, to 5% of the maternal concentration. Thereafter, the ratio ranged from 8 to 13%. The implications of this finding are discussed.

Human seminal plasma contains a wide range of trophoblast-‘specific’ proteins

Summary Seminal plasma samples were assayed for placental proteins (chorionic gonadotrophin, placental lactogen, pregnancy-specific beta-1-glycoprotein, placental protein 5 and alphafetoprotein), using specific radioimmunoassay methods. Human seminal plasma was shown to contain substantial amounts of immunoreactive materials corresponding to placental proteins but not to fetal proteins.

Oral versus local treatment of vaginal candidosis

A comparative study was conducted to compare the results of the use of oral and local vaginal therapy in the treatment of vaginal candidosis. Forty‐five patients with clinical and mycological evidence of vaginal candidosis were recruited and were randomly allocated to one of the treatment groups. Twenty‐four patients received ketoconazole orally (400 mg/day for 5 days) and 21 patients received nystatin vaginal pessaries (100,000 units twice/day for 7 days). Seven out of 20 rectal swabs (35%) were positive for Candida albicans. Both drugs were significantly effective in relieving patients symptoms and physical signs. The mycological cure rates were 87.5% and 81%, and the relapsing rates were 0% and 5.9% for the ketoconazole and nystatin groups, respectively. Ketoconazole oral therapy had generally slightly higher results than local nystatin therapy in the treatment of vaginal candidosis, yet the difference was statistically insignificant.

Raised circulating levels of interleukin-6 in women with an intrauterine contraceptive device.

The aim of this study was to determine whether the presence of an intrauterine contraceptive device (IUCD) causes a systemic elevation of interleukin-6 (IL-6). The control group comprised 29 women with normal cycles and who were not using any form of contraception and the study group comprised 74 women who had had an IUCD in place for 10-24 months. Of these, 45 had intermenstrual bleeding. Systemic IL-6 was undetectable (minimum detection limit of the assay is 5 pg/ml) in the control but was raised in 20% of the women fitted with an IUCD (p < 0.01). There was no difference between IL-6 levels in IUCD users who had intermenstrual bleeding and those who did not. These results suggest that the effects of chronic IUCD usage may not be limited to the endometrium.