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Biomedical subjects

S Basnayake

Publications and source records attributed to S Basnayake.

10 recordsLinked to original sources

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.

Administration, Intravaginal↗

Bleeding patterns and acceptability among Norplant users in two Asian countries.

Changes in menstrual bleeding patterns are the most frequent reason for discontinuing NORPLANT during the first year of use. Although NORPLANT is used by more women in Asia than in any other region, the changes that occur among these women are not well documented. In pre-introductory clinical trials of NORPLANT in the Philippines and Sri Lanka, 175 women were enrolled with greater than 95% continuing the method after one year. Daily menstrual bleeding calendars were kept by 94% of subjects for nine months and by 66% for one year. In contrast to findings in previous studies which showed that approximately 60% of NORPLANT users had bleeding disruptions in the first year of use, almost all of these women experienced bleeding disruptions. In a one-year study of menstrual pattern changes, increased bleeding was found to occur with the same frequency as reduced bleeding. However, the changes experienced by the Asian women tended to be decreases, rather than increases, in menstrual bleeding.

Adult↗

The effect of oral contraceptive formulation and field-workers: a cautionary tale.

This paper examines oral contraceptive continuation rates and reported side effects in a large scale clinical research project conducted in Sri Lanka. The project evaluated standard- and low-dose pills used with and without vitamin supplements. Differences in continuation rates and perception of side effects are used to illustrate the impact that family planning field-workers can have on women's use of oral contraceptives.

Attitude↗

A comparison of Norinyl and Brevicon in three sites in Sri Lanka.

A set of 3 four-cell randomized, blind clinical trials was carried out in Sri Lanka to evaluate the impact of vitamin supplements and different oral contraceptive formulations. This paper concentrates on the comparisons of oral contraceptives. There seems to be no important difference between Norinyl, a standard-dose oral contraceptive, and Brevicon of a lower estrogen dosage--in either continuation or side effects. Continuation at one site was higher among Norinyl users, but several factors led us to the belief that this difference was due to differences in field worker performance rather than to the pharmacological properties of the drugs. Some differences in side effects were observable along predictable lines; breakthrough bleeding was more common among Brevicon users than Norinyl users, and most other side effects were more frequent among Norinyl users, although these latter differences were quite small, and there were several exceptions.

Adolescent↗

Evaluation of safety, efficacy, and acceptability of NORPLANT implants in Sri Lanka.

This paper presents findings based on a one-year pre-introductory clinical investigation concerning safety, efficacy, and acceptability of the new contraceptive NORPLANT implants in Sri Lanka. The study is based on 400 acceptors of the implants at two clinics in Sri Lanka. Acceptors' mean age was 27 years, mean number of children was about two, and average educational attainment was eight years. Nearly half of the acceptors did not want to have another child. Follow-up was conducted at one, three, six, and twelve months. The one-year termination rate due to medical problems was very low, and the one-year life-table pregnancy rate was 0.5. Menstrual pattern disruption was the most frequently reported complaint with the implants. Amenorrhea increased in the first three months of use, and intermenstrual bleeding was common among those menstruating. In spite of these changes and some significant variations between the acceptors in the two study center, the overall degree of satisfaction with the implants was very high. The features most important to the acceptability of the implants were low risk of pregnancy, the long duration of action, and the convenience of use. The results of the study suggest that NORPLANT implants are safe, effective, and highly acceptable to Sri Lankan women.

Adolescent↗

Early symptoms and discontinuation among users of oral contraceptives in Sri Lanka.

The relationship between symptoms reported during the first two cycles of oral contraceptive use and subsequent discontinuation was studied using data from a comparative clinical trial of two oral contraceptives (standard dose and low dose) in Sri Lanka. Among 24 symptoms considered, the most commonly reported were headache, nausea, irritability, dizziness, tiredness, intermenstrual spotting/bleeding, backache, abdominal pain, vomiting, and hair loss. Headache, nausea, vomiting, and dizziness were closely associated with each other and strongly predictive of discontinuation for both drugs. No other symptoms were consistently associated with each other or with subsequent discontinuation. Intermenstrual spotting/bleeding was associated with later discontinuation of the standard dose preparation, but not the lower dose preparation.

Adolescent↗