Biomedical subjects

M M Shaaban

Publications and source records attributed to M M Shaaban.

At least 19 recordsLinked to original sources

PubMed1996

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.

Adult↗

PubMed1996

The perimenopause and contraception.

OBJECTIVES: To review the implications of pregnancy in women in their forties and the contraceptive options open to them. METHOD: Medline and popline reviews of the literature. RESULTS: Women in their forties are still potentially fertile, and pregnancy in this age group is attended with increased maternal mortality, spontaneous abortion, fetal anomalies and perinatal mortality. In developing countries, these risks are compounded by high parity and poor medical care. Contraception for women in this age group has special risks and benefits, both should be balanced to choose between the different options available. Recent epidemiological and clinical pharmacology studies have indicated the safety of extending the use of combined oral contraceptives (COCs) beyond the age of 35 years and up to menopause. The improved picture of COCs has largely resulted from the use of low-dose-formulations, and avoidance of their use in women with risk factors for developing cardiovascular diseases. Besides their high reliability, which is desirable at this age, COCs will prevent the occurrence of climacteric symptoms and menstrual irregularities which are frequently complained of in the premenopausal years. Moreover, the use of COCs has a substantial protective effect against ovarian and endometrial cancers. Women who have reasons for avoiding COCs can use progestogen-only contraceptives like pills, depot injectables and implants. Norplant combines high efficacy and the long-term effect. Both copper-releasing and levonorgestrel-releasing IUDs (LNG-IUD) combine the advantages of high efficacy and long term effect. The reduced fecundity above the age of forty can allow extending the use beyond the accepted term, and up to one or two years beyond the menopause without the need for replacement. The levonorgestrel IUD has the advantage of reducing the amount of menstrual bleeding. The extent of use of barrier methods will depend upon the availability of a back-up by abortion service in case of failure. The condom has the added benefit of protection against STDs. Male or female sterilization is an excellent contraceptive option, provided that this approach is culturally acceptable and available at reasonable cost and low risk. CONCLUSION: Increasing the number of contraceptive options available to premenopausal women will improve proper counseling and enhance compliance.

Adult↗

PubMed1996

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.

Adult↗

PubMed1995

Comparative study on intermittent versus continuous use of a contraceptive pill administered by vaginal route.

A multicenter, international, randomized, comparative trial was conducted to assess the acceptability, efficacy and safety of two different schedules of a contraceptive pill, containing 250 micrograms levonorgestrel and 50 micrograms ethinyl estradiol, administered by the vaginal route. One schedule of daily administration for 21 days with a seven-day interruption to allow withdrawal bleeding was compared to daily administration without interruption for bleeding. A total of 900 women were recruited in three countries, Brazil, Egypt and China; 7,090 women-months of vaginal pill use were recorded (3,364 using the pills intermittently and 3,726 continuously). Four undesired pregnancies occurred, one in Egypt and three in China, all four in women using the pills intermittently. There was a statistically significant difference (p = 0.486) in pregnancy rate between the two groups. There were no other significant differences in discontinuation rates despite marked differences in bleeding patterns, amenorrhea predominating in the continuous use group. Hemoglobin levels increased significantly in the two groups but hematocrit was significantly higher in the continuous use group.

Administration, Intravaginal↗

PubMed1993

Acute viral hepatitis in pregnancy.

OBJECTIVE: To describe the clinical outcome of pregnancy and vertical transmission of acute viral hepatitis in pregnancy. METHODS: Forty-eight pregnant patients with acute viral hepatitis were evaluated clinically and by abdominal ultrasonography. Serological studies for hepatitis markers were performed using radioimmunoassay. The results were evaluated using Student's t-test and tests of proportion. RESULT: Thirty-five (72.9%) delivered live birth babies at term, while 13 (27.1%) had fetal complications and/or losses. The percentage of fetal complications and/or losses was higher in patients who had non-A, non-B hepatitis (30.8%) than those who had type B hepatitis (25%). The most common fetal complication was premature delivery (14.9%) followed by stillbirth and abortion (8.3%) for each. The overall percentage of vertical transmission of hepatitis B virus was 2 out of 27 (7.4%). CONCLUSION: Acute viral hepatitis carries a high risk for both mother and fetus. Routine vaccination of all susceptible women and babies against hepatitis B is recommended in endemic areas.

Acute Disease↗

PubMed1993

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.

Abortion, Spontaneous↗

PubMed1993

Comparative study on the efficacy, acceptability, and side effects of a contraceptive pill administered by the oral and the vaginal route: an international multicenter clinical trial.

The objective of this multicenter randomized clinical trial was to compare the efficacy, acceptability, and occurrence of side effects associated with the oral versus vaginal route of administration of contraceptive pills. Eight hundred nineteen healthy, parous women of reproductive age were recruited at family planning clinics and research centers, members of the South to South Cooperation in Reproductive Health, in seven countries of the developing world. These women were randomly assigned to use either oral or vaginal administration of the same contraceptive pill, which contained 250 micrograms levonorgestrel and 50 micrograms ethinyl estradiol. No statistically significant differences were found in discontinuation rates between the two groups after 1 year. Involuntary pregnancy rates after 1 year were not statistically significantly different between the two groups. The vaginal route of administration appears to be as acceptable and efficacious as the oral route.

Administration, Intravaginal↗

PubMed1993

Experience with NORPLANT in Egypt.

Experience with the contraceptive NORPLANT in Egypt dates back to early 1980 when the first multicentre trial was initiated. To date, more than 3000 women have received this contraceptive at the Assiut University Family Clinic alone. Analysis of the overall experience in this clinic has indicated a 5-year cumulative continuation rate of 51 and a pregnancy rate of 1.8 per 100 women. Clinical pharmacology studies pertaining to the safety of NORPLANT in our community have indicated no deleterious effect on the lipid profile, liver functions and blood coagulation system. Two studies conducted in Egypt have indicated that the initiation of NORPLANT use shortly after delivery does not have any unfavourable effect on lactational performance, or on physical or psychomotor development of the breast-fed infants. This is particularly important in Arab and Moslem cultures where prolonged breast-feeding is emphasized. A study utilizing focus-group discussion to assess users' attitudes to NORPLANT has indicated the need to improve the informational/educational package given in the service by emphasizing certain cultural considerations. On the whole, this first implant method has proven to be safe and acceptable in Egypt, where there is a special need for long-term methods for contraception, particularly as sterilization is not socially acceptable.

Adult↗

PubMed1991

Contraception with progestogens and progesterone during lactation.

The growth and development of breastfed infants whose mothers used the contraceptive implants Norplant containing levonorgestrel and the injectable containing norethisterone enanthate were studied. Each group comprised of 120 women who initiated the use during the 5th to 7th week postpartum and were compared with a similar number of IUD using mothers. The breastfeeding performance did not differ between groups. The infants of the three groups performed similarly as regards their physical growth and health as well as the time of acquisition of the various milestones of psychomental development. A vaginal ring releasing 10 mg of the "natural" progesterone per 24 h was tested in breastfeeding mothers. The continuous use of the ring produced a serum level of progesterone around 4 ng/ml. This was effective in augmenting lactational infertility even through the later phases of breastfeeding when such an effect starts to wane off. The use of the ring proved to be acceptable and had no ill-effect on breastfeeding or infant growth or health. Using the natural progesterone as a contraceptive adds a new measure of safety, since the amount of the steroid secreted in the mother's milk will not be effectively absorbed from the infant's gut. These studies suggest the possibility of using two new methods for breastfeeding mothers; Norplant and the progesterone vaginal contraceptive ring. These can be initiated early postpartum, whenever this is considered needed.

Contraceptive Devices, Female↗

PubMed1990

The recovery of fertility during breast-feeding in Assiut, Egypt.

A longitudinal study of twenty-six breast-feeding and twelve non-breast-feeding postpartum women was conducted in Assiut, Egypt in order to determine the time that ovulation resumed after childbirth, and the effect of breast-feeding frequency on the period of lactational anovulation. Breast-feeding women experienced the onset of follicular development, vaginal bleeding, ovulation and pregnancy significantly later than women who did not breast-feed. Ovulatory and non-ovulatory breast-feeders reported similar frequencies of breast-feeding episodes. The introduction of dietary supplements commonly preceded ovulation. An algorithm using three simple variables observable to the breast-feeding mother was found to predict up to 100% of the first ovulations. All breast-feeding women who did not give supplements and did not have a vaginal bleeding episode by 6 months postpartum were anovular by strict criteria for ovulation. Ovulation did not precede bleeding or supplementation in the women who experienced these events before 6 months, yielding a highly effective formula for preventing unplanned pregnancy by the informed use of breast-feeding.

Adolescent↗

PubMed1988

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).

Adolescent↗

PubMed1987

The recovery of ovarian function during breast-feeding.

The pattern of breast-feeding was daily recorded and the serum concentrations of prolactin (PRL), FSH, LH, estradiol (E2) and progesterone (prog) were measured at weekly intervals in 26 breast-feeding mothers from the time of delivery and up to the resumption of regular ovulation or to the end of the first postpartum year. Twelve postpartum non-breast-feeding women were similarly studied as controls. An algorithm was used to characterize ovulatory events into three types: the first, with evidence highly suggestive of normal ovulation (EHSO), the second, with evidence of probable ovulation (EPO) and the third with evidence indicating questionable ovulation or deficient corpus luteum function (QO/DCT). Pregnancy preceded the first menstruation in one woman in each of the breast-feeding and control groups. Of the 19 breast-feeding women who started to menstruate during the first postpartum year, five had EHSO, one had EPO, 5 had EQO/DCL and 7 had anovulatory (AO) menstruation. The corresponding figures in the 11 controls were 6, 2, 3 and 0. Pregnancy occurred before a second menstruation in one woman in both the study group and the controls. In 18 breast-feeding women observed, the second menstruation was preceded by EHSO in 7, by EPO in 3, by EQO/DCL in one and AO in 7. In 10 controls the corresponding figures were 7, 3, 0 and 0. Out of a total of 79 menstruations observed during breast-feeding the incidence of AO was 30% and of QO/DCL was 15%. In actively breast-feeding mothers, hyperprolactinemia persisted for more than 1 yr. However, menstruation and ovulation occasionally occurred before the drop of PRL to concentrations seen during the normal menstrual cycle. In the majority of women, low E2 levels were present during lactational amenorrhea, but with occasional spikes in some. A few women maintained somewhat high values of E2 for several weeks before the resumption of menstruation. The implications of these hormonal findings to the attempts to improve on the contraceptive effect of breast-feeding are discussed.

Adult↗

PubMed1987

Five-year experience with Norplant implants in Assiut, Egypt.

This report describes the five-year experience of the first 250 acceptors of NORPLANT implants in Assiut, Egypt. The five-year net continuation rate was 58.6 per 100 women. The five-year net cumulative pregnancy rate was 1.6 per 100 women. About three-fourths of those who continued use of this contraceptive through the fifth year reported having regular cycles. There was definite improvement in the bleeding pattern with time. The five-year net termination rate because of bleeding problems was 17.7 per 100 women. After 5 years of NORPLANT use there was a slight, statistically insignificant increase in weight, systolic and diastolic blood pressures. Of those who used contraceptives after the end of the five-year term of NORPLANT, about one-third opted to have reinsertion of the implants for a second term. About 96% of those who used NORPLANT through the fifth year reported that their experience with the contraceptive had been satisfactory.

Adult↗

PubMed1986

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.

Breast Feeding↗

PubMed1985

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.

Adult↗

PubMed1985

Influence of levonorgestrel contraceptive implants, NORPLANT, 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.

Adult↗

PubMed1984

Hormonal changes during the first year of use of subdermal levonoregestrel implants, Norplant.

Sixty-three women had NORPLANT implants inserted during the first eight days of the menstrual cycle. Blood specimens were withdrawn at the time of insertion and every three days during one of the following months of observation; the first, third, sixth, ninth and twelfth month after insertion. Ten subjects were sampled at multiple times during implant use. A total of 83 months of observation was available. The serum concentrations of levonorgestrel (LNG), FSH, LH, prolactin (PRL), estradiol (E2) and progesterone (prog) were measured in each specimen. LNG concentration rapidly declined during the first 15 days of use, the decline became more gradual during the subsequent two weeks, and an almost steady level was reached during the remainder of the year. There were no significant trends of change in the levels of FSH, LH, E2 and prog during the year. Frequent peaks in E2 concentration were observed and were generally associated with or followed by LH surges. PRL concentration showed a slight but significant rise during the second half of the year. Rises in prog concentration suggestive of ovulation occurred in 36 percent of the months of observation. However, in all these instances, there were evidences suggestive of deficient luteal phase. The bleeding episodes were usually, but not always, related to decline in E2 and prog concentrations.

Adult↗

PubMed1984

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.

Adult↗