Mamdouh M. Shaaban

A randomized clinical trial of a levonorgestrel-releasing intrauterine system and a low-dose combined oral contraceptive for fibroid-related menorrhagia.

To compare the efficacy of a levonorgestrel‐releasing intrauterine system (LNG‐IUS) with that of a low‐dose combined oral contraceptive (COC) in reducing fibroid‐related menorrhagia.

Contraceptives for lactating women: A comparative trial of a progesterone-releasing vaginal ring and the Copper T 380A IUD

From approximately one week before normal ovulation resumes, lactating women require protection against pregnancy by a contraceptive that is safe for both infant and mother in a multicenter one-year study, the natural hormone, progesterone, delivered vaginally by a sequence of four contraceptive rings designed for continuous use, was evaluated as a contraceptive for nursing mothers in comparison with the Copper T 380A IUD. Individual rings release in effective average dose of 10 mg day for a 3 month period. Evaluation included measures of lactational performance as well as of contraceptive efficacy and safety to mother and child. Nine participating clinics enrolled 802 ring users and 734 IUD acceptors between postpartum days 29 and 63. Life table analyses were performed with parallel decrements for ring and IUD subjects. Continuation in the study and analysis required that subjects not stop breastfeeding. The ring, with a one-year pregnancy rate of 1.5 per 100, did not differ significantly from the IUD with respect to contraceptive effectiveness (p > 0.05). More than half of the ring subjects were continuing at 6 months post admission and a quarter (23.5 per hundred) were still using the ring and breastfeeding one year after admission. Women with the IUD, however, had higher continuation rates (p < 0.001) at both time points. The largest single decrement for each method was that for weaning. Ring users had more complaints of vaginal problems but had fewer vaginal disorders on examination. At 12 months postpartum, 46 per 100 continuing ring users remained in amenorrhea. Lactation performance and the health and weight gain of the infants were similar among users of either regimen.

Assessing the acceptability of NORPLANT implants in four countries: findings from focus group research.

In 1986-87, a qualitative research project was conducted in the Dominican Republic, Egypt, Indonesia, and Thailand to expand understanding of the acceptability of NORPLANT contraceptive implants beyond inferences made on the basis of continuation rates. In each of the four study sites, focus group discussions or in-depth interviews were held with potential acceptors, current NORPLANT users, discontinuers, husbands of women in these three groups, and service providers. Nonclinical participants generally had little formal education and lived primarily in urban or semi-urban areas where NORPLANT has been available for at least five years. The study focused on attitudes, perceptions, and experiences of each group regarding NORPLANT implants. Results suggest that factors having an impact on the acceptability of NORPLANT implants fall into three general categories: medical/technical, cultural/religious, and informational/educational. This article discusses each of these categories, including programmatic implications of the findings, and puts forward recommendations for enhancing NORPLANT introduction efforts on the basis of these findings.

Pictorial blood loss assessment chart in the evaluation of heavy menstrual bleeding: diagnostic accuracy compared to alkaline hematin.

Background/Aims: The pictorial blood assessment chart (PBAC) is a method for evaluation of menstrual blood loss (MBL). This study was conducted to evaluate the accuracy of the PBAC score in diagnosing MBL compared to alkaline hematin as a gold standard. Methods: Two cohorts were constructed: 30 women who reported ‘normal’ menses and 170 who reported ‘heavy’ menses. Evaluation of menstruation was performed using the PBAC score and by alkaline hematin. Results: Women who reported normal menses were younger (p = 0.071), had lower parity [median parity of 3 (range 1–6) vs. 4 (range 1–12), p < 0.001] and higher hemoglobin levels (11.1 ± 1.1 vs. 10.1 ± 1.6 g/dl, p < 0.001). PBAC scores and MBL by alkaline hematin were significantly correlated (Spearman r = 0.600, p < 0.001). The PBAC score of 150 had a ĸ of 0.593 (95% CI 0.480–0.687) and an area under the curve of 0.796 (95% CI 0.770–0.821). In a multivariable regression PBAC score >150, presence of blood clots and period duration >7 days were independent predicators of heavy menstrual bleeding with an overall area under the curve of 0.858 (95% CI 0.835–0.879). Conclusions: The PBAC score is a simple and accurate tool for semiobjective of MBL that can be used in clinical practice to aid the decision about treatment and follow-up.

A Prospective Study of NORPLANT Implants and the TCu 380Ag IUD in Assiut, Egypt

This report describes the 1st year of experience of 250 acceptors of NORPLANT implants and 100 TCu380Ag IUD acceptors. The net cumulative 1 year pregnancy rate was about 1/100 women for each group. The continuation rate was 90/100 for implant users and 87/100 for IUD users. Disruption of menstrual rhythm was the main complaint of users of NORPLANT implants in the early months although complaints of menstrual irregularities were more frequent among users of the TCu 380Ag. The incidence of menstrual irregularities among implant users diminished with time. Implant users tolerated early disruption of their menstrual rhythm to a degree that surpassed expecations. There were no infections following placement of the implants. (authors modified)

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.

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.

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.

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.