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Biomedical subjects

S Díaz

Publications and source records attributed to S Díaz.

At least 91 records · Page 5Linked to original sources

Recovery of fertility and outcome of planned pregnancies after the removal of Norplant subdermal implants or Copper-T IUDs.

The recovery of fertility after discontinuation of NORPLANT implant use was assessed in ninety women who stated a desire for a new child at the time of removal. Three subjects were lost to follow-up after removal. The cumulative probability of conception in the remaining 87 women was 25, 49, 73 and 86 percent at one, three, six and twelve months after removal, respectively. Nine observations were censored either because of the use of a contraceptive method soon after removal of the implants (n = 7) or separation (n = 2). All other cases were pregnant at the end of two years with exception of three subjects where a male factor for infertility was present. There was no significant correlation between the length of NORPLANT use and the length of the interval from removal to conception. A significantly higher frequency of intervals longer than 6 months was observed among women older than 30 years as compared to younger women. Pathology during pregnancy was cholestasia (n = 5), hypertension (n = 1) and gestational diabetes (n = 1). The outcome was term delivery in 59 cases, premature delivery in 4 cases, and spontaneous abortion in 7 cases. One woman is still pregnant and the outcome is unknown in 4 cases. One premature infant died. A contemporary control group of Copper T users enrolled under the same criteria as NORPLANT implant users provided 44 women who had the device removed to become pregnant. The cumulative probability of pregnancy was 27, 69, 84 and 89 at one, three, six and twelve months and all were pregnant by the end of the second year. Six censored observations occurred because of the use of another contraceptive method after removal (n = 3) or loss to follow-up (n = 3). The outcome of pregnancy was term delivery in 23 cases and abortion in 7 cases. Recovery of fertility occurred at a normal rate after NORPLANT implant removal and the incidence of problems detected in the ensuing pregnancy were within the expected range for Chilean women.

Age Factors↗

Bleeding pattern, outcome of accidental pregnancies and levonorgestrel plasma levels associated with method failure in Norplant implants users.

The aim of this study was to characterize the bleeding pattern, the outcome of pregnancies and the levonorgestrel plasma levels associated with method failures in Norplant implants users. Nineteen pregnancies are reported in 458 woman and 21,589 woman-months observed during the first eight years of Norplant use. Pregnancy rates increased slightly during the first six years of use, attaining a Pearl Index above three thereafter. All women who became pregnant had experienced a regular bleeding pattern in the six months preceding conception. Levonorgestrel plasma levels observed at different intervals before conception and during the conceptional cycle were similar to those observed in non-pregnant women at comparable intervals after Norplant insertion. The nineteen pregnancies ended in thirteen term deliveries, one premature delivery, three abortions and two ectopic pregnancies. No abnormalities were found in the infants. The two ectopic pregnancies are the only ones reported for Norplant users in The Population Council studies. The overall incidence is less than 0.8 per 1000 woman-years.

Abortion, Spontaneous↗

Clinical chemistry in women treated with six levonorgestrel covered rods or with a copper IUD.

A group of women treated with six levonorgestrel covered rods participated in a study on general chemistry and blood levels of selected hormones at treatment months 20 and 65. A comparable group of Copper T users served as control. Parameters analyzed were the SMA 12 chemistry profile, estradiol, testosterone, cortisol, T3, T4 and TSH. Samples from treated and control subjects were drawn within the same calendar period and were run simultaneously for the assay of each parameter. The values observed were within the normal limits. Significantly higher values of total protein and albumin and lower levels of estradiol and testosterone were found among implant users when compared to the control group. The results suggests little or no metabolic changes in users of six levonorgestrel covered rods which release a daily dose of approximately 105 micrograms.

Adolescent↗

Plasma levonorgestrel and progesterone levels in women treated with silastic covered rods containing levonorgestrel.

Levonorgestrel and progesterone plasma levels were measured in women bearing levonorgestrel subdermal implants. Two groups using four or six levonorgestrel covered rods and one group of non-hormonal contraceptors were compared. Blood samples were drawn twice a week for six consecutive weeks at different intervals after treatment administration. The mean levonorgestrel levels (mean +/- S.D.) observed in the four rods group was .49 +/- .13 ng/ml in the first year and decreased to .34 +/- .06 in the fifth year of treatment. The mean values observed in the six rods group were .70 +/- .15 ng/ml in the second year and .43 +/- .11 in the sixth year. The levonorgestrel plasma levels were slightly above those found with Norplantr implants in the four rods group and well above it in the six rod group. The highest plasma progesterone value found in each sampling period was above 9 nmol/l in 7 (14%) out of 50 subjects in the four rods group, in 2 (4.3%) out of 47 subjects in the six rods group and in all the 49 control women. In 4 out of the 7 subjects from the 4 rods group and in the two subjects from the 6 rods group, the highest progesterone value was preceded and followed by values lower than 6 nmol/l. It was concluded that the progesterone levels were seldom compatible with the occurrence of ovulation in women treated with four or six levonorgestrel covered rods which release an estimated daily dose of 70 and 105 micrograms, respectively.

Adolescent↗

Fertility regulation in nursing women: VII. Influence of NORPLANT levonorgestrel implants upon lactation and infant growth.

The objective of this study was to test the influence of NORPLANT implants upon lactation and infant growth. The results obtained during the first postpartum year are reported. One-hundred women were enrolled in the implant group. The control group was formed by 100 women who received a Copper T IUD. Treatments were administered at day 55 +/- 3. At admission all subjects were in exclusive breastfeeding with an adequate weight increase of the infant. No significant differences were found between the treated and control groups in the percentage of women in full nursing at different postpartum intervals, except for the 12th month postpartum where a lower percentage of cases from the NORPLANT group was in the full nursing category. No difference was found in the time of weaning. The infants showed a normal weight gain rate in both groups although the girls from the NORPLANT group showed a significantly lower daily weight increase during the 4th month than the girls from the IUD group. No pregnancies were diagnosed. No women asked for implant removal during the first year. No serious side effects related to treatment were detected. Bleeding irregularities were rare during breastfeeding which is in contrast with what occurs in non-nursing women treated with NORPLANT implants. Levonorgestrel concentrations found in milk were variable and individual values ranged from 23 to 311 pg/ml. The dose received by the infant can be estimated around 15 to 18 ng/Kg/day during the first month of treatment when the higher plasma values of levonorgestrel are observed. These levels is conjunction with the clinical observations reported here minimize the potential problems associated with levonorgestrel transference through maternal milk. Nevertheless, long-term studies are required to settle this matter and until more information is available, NORPLANT implant use in lactating women should be limited to cases who require a highly effective contraceptive method and where non-hormonal methods of similar effectiveness are contraindicated or unacceptable.

Adolescent↗

Fertility regulation in nursing women: VIII. Progesterone plasma levels and contraceptive efficacy of a progesterone-releasing vaginal ring.

The objectives of this trial were to test the contraceptive efficacy and measure progesterone plasma levels of women using progesterone-releasing rings during lactation. Two types of rings delivering an average of about 5 mg or 10 mg of progesterone per day were tested in 128 healthy nursing women. A control group was formed by 127 Copper T users. Rings were inserted at day 60 postpartum and replaced every 3 months with a new one. Initially progesterone plasma levels were around 10 nmol/l and 15 nmol/l for rings releasing 5 and 10 mg per day, respectively, and decreased slightly after 30 days. Levels observed in subsequent segments of use approximated those of the first segment. These levels are within the range shown to inhibit fertility in lactating women. One pregnancy was diagnosed in 739 woman-months of progesterone ring use, and none occurred in 794 woman-months of Copper T use, which contrasts with the high incidence of pregnancy in a group of untreated nursing women where 19 pregnancies resulted during 677 woman-months. No deleterious effects were detected lactation and infant growth or maternal and infant health. It is concluded that the vaginal rings releasing progesterone are a suitable contraceptive method for lactating women.

Clinical Trials as Topic↗

Fertility regulation in nursing women. VI. Contraceptive effectiveness of a subdermal progesterone implant.

Six progesterone pellets implanted subdermally were tested as contraceptive method for lactating women. One pregnancy was diagnosed in 1614 woman-months of observation, a failure rate which was similar to that observed in a contemporary group of Copper T users. Nineteen pregnancies were diagnosed in the 677 woman-months observed in untreated lactating women. The progesterone implants were effective when administered either at 30, 60 or 240 days after delivery. The duration of the effective life was 5 months and fertility was quickly restored afterwards. There were no deleterious effects upon maternal or infant health or upon lactation and the rate of child growth. The main problem encountered was the occurrence of pellet expulsion at a variable rate which appeared related to the manufacturing procedure.

Adolescent↗

Fertility regulation in nursing women: III. Short-term influence of a low-dose combined oral contraceptive upon lactation and infant growth.

The study was designed to test the short-term influence of a low-dose combined oral contraceptive upon lactation and infant growth when treatment was initiated at day 30 postpartum. The contraceptive tested contained ethinyl estradiol 0.03 mg and levonorgestrel 0.15 mg. Two control groups were formed by women who received either an oral placebo or an injectable placebo at day 30 postpartum. An exacting list of requirements for admission and continuation in the study was applied to all groups. The oral contraceptive group had a lower percentage of cases in exclusive breastfeeding at day 91 postpartum when compared to both control groups. Infants in the oral contraceptive group showed a significantly lower average absolute weight at days 61 and 91 postpartum and a significantly lower average daily weight increase during the first month of treatment when compared to both control groups. It was concluded that the oral contraceptive tested had a negative influence upon lactation and child growth.

Adult↗

Fertility regulation in nursing women: IV. Long-term influence of a low-dose combined oral contraceptive initiated at day 30 postpartum upon lactation and infant growth.

The study was designed to test the long-term influence of a low-dose combined oral contraceptive upon lactation and infant growth when treatment was initiated at day 30 postpartum. The contraceptive tested contained ethinyl estradiol 0.03 mg and levonorgestrel 0.15 mg. Two control groups were formed by women who received an injectable placebo or a Copper T at day 30 postpartum. Women in the injectable placebo group received non-hormonal contraceptives at day 90 postpartum. An exacting list of requirements for admission and continuation in the study was applied to all groups. The oral contraceptive group had a significantly lower percentage of cases in full nursing from the 4th through the 10th postpartum month when compared to both control groups. The average absolute weight of infants in the oral contraceptive group was significantly lower at several ages when compared to the placebo group but not when compared to the Copper T group. No adverse side effects upon infant's health were detected. It was concluded that the oral contraceptive tested showed a moderate inhibitory influence upon lactation when treatment was initiated at the beginning of the second postpartum month.

Adult↗

Fertility regulation in nursing women: V. Long-term influence of a low-dose combined oral contraceptive initiated at day 90 postpartum upon lactation and infant growth.

The study was designed to test the long-term influence of a low-dose oral contraceptive upon lactation and infant growth when treatment was initiated at day 90 postpartum. The contraceptive tested contained ethinyl estradiol 0.03 mg and levonorgestrel 0.15 mg. The control group was formed by women who chose non-hormonal contraception at the same postpartum time. Only cases who were in exclusive breast-feeding with a minimal infant daily weight increase of 20 g per day during the third month of age were included. The oral contraceptive group showed a significantly lower percentage of cases in full nursing from the 6th postpartum month and a significantly lower infant weight increase during the 4th month of age when compared to the control group. No differences were found in the absolute infant weight up to one year of age. No adverse side effects upon infant's health were detected. It was concluded that the oral contraceptive tested showed a moderate inhibitory influence upon lactation when treatment was initiated at day 90 postpartum.

Adult↗

Growth pattern of selected urban Chilean infants during exclusive breast-feeding.

This report describes the growth pattern of healthy, low middle and low socioeconomic class Chilean infants during exclusive breast-feeding. Two-hundred forty-two infants who were on exclusive breast-feeding at day 30 postpartum entered the study. Of these, 59% were fully nursing at 6 months and grew at a normal rate without receiving either supplementary milk or nondairy food. Supplementary feedings were administered in 27% of cases because of suspected primary inadequate milk output and in 14% of cases for other reasons such as pregnancy, illness, maternal work, or self-prescription. Full nursing provided the highest rate of weight increase during the first 3 months of life and a greater weight gain for boys than for girls up to the age of 6 months. Gastrointestinal pathology, malnourishment, or hospitalization were rare events in this population. It is concluded that maternal milk alone, if produced in sufficient amounts, can maintain normal growth up to the 6th month of life. The study supports the choice of exclusive breast-feeding on demand plus child growth monitoring up to 6 months over routine prescription of supplements at earlier times particularly where supplement administration fails to meet individual requirements.

Adolescent↗

Fertility regulation in nursing women. II. Comparative performance of progesterone implants versus placebo and copper T.

A clinical study was designed to test whether sustained administration of progesterone to nursing mothers could prolong lactation and delay the postpartum recovery of fertility. The hormone was administered by subdermal implantation of six pellets that each contained 100 mg of progesterone. This treatment was administered to 84 fully nursing women on day 30 post partum. Control groups were composed of 130 fully nursing women who received an injectably placebo, and by 125 fully nursing women who received a TCu 200 intrauterine contraceptive device. An exacting list of requirements for admission to and continuation in the study was applied to all groups. No pregnancies occurred in the progesterone-treated group from the second to the sixth postpartum month. This period coincided with the period of elevation plasma progesterone attributable to hormone released from the implants. The cumulative probability of pregnancy in the placebo group was 10.2 per 100 women at the sixth month. Treatment with progesterone did not change the duration of lactation or the rate of child growth, and no adverse effects were recorded. These results warrant further investagation of the use of progesterone as an alternative method to prevent conception in nursing women.

Birth Weight↗

Plasma progesterone levels following subdermal implantation of progesterone pellets in lactating women.

The magnitude and duration of elevated plasma progesterone levels resulting from subdermal implantation of progesterone pellets were investigated in full nursing women. This condition was chosen because it is associated with a low rate of ovulation and minimal endogenous progesterone production. In addition, treatment with progesterone pellets was intended to be a substitute for oral or parenteral administration of synthetic progestogens to nursing mothers. A control group of full nursing women receiving no hormones provided blood samples so that basal plasma progesterone levels from the second to the sixth post-partum month could be assessed. Progesterone pellets were implanted subdermally on day 30-35 after delivery. Insertion of 2, 4 or 6 pellets each containing 100 mg of progesterone caused an initial elevation of plasma progesterone to 5.9, 9.9 and 13.5 nmol/l, respectively. This initial elevation was followed by a gradual decline, so that basal levels were attained at 70, 100 and 150 days after insertion of 2, 4 or 6 pellets. Implantation of 6 progesterone pellets led to a significant decrease in the ovulation rate of nursing women. These results indicate that subdermal implantation of 6 progesterone pellets can provide biologically effective levels of the hormone for up to 5 months.

Adolescent↗