Clinical study of a monophasic pill containing 20 microg ethinylestradiol and 150 microg desogestrel in Thai women.

OBJECTIVES: To evaluate the contraceptive reliability and clinical effects of a monophasic oral contraceptive containing 20 microg ethinylestradiol and 150 microg desogestrel (Mercilon) in Thai women. METHOD: The study was carried out at the Family Planning Clinic of King Chulalongkorn Memorial Hospital, Bangkok, Thailand. One hundred and forty six healthy women of fertile age were enrolled and treated with the study oral contraceptives for 12 cycles. Clinical data of vaginal bleeding, side effects, blood pressure and body weight were assessed periodically. RESULTS: One thousand four hundred and twenty five cycles were evaluated. No conception occurred. The cycles were almost regular. The incidence of irregular bleeding was highest in the first cycle, after the third cycle, the value was below 4 per cent. Side effects were very few. There was no change in blood pressure. A slight decrease in mean body weight was observed. CONCLUSION: The oral contraceptive containing 20 microg ethinylestradiol and 150 microg desogestrel has high contraceptive efficacy, good cycle control and minimal side effects.

DMPA use above the age of 35 in Thai women.

A prospective study of depot-medroxyprogesterone acetate (DMPA) use in women aged above 35 years was conducted in Bangkok, Thailand. The objectives of the study were to evaluate efficacy, continuation rate, and side effects of DMPA use in these women. A total of 60 women were enrolled in a one-year clinical trial. Their mean age was 38 years. Most of them had completed primary school. No accidental pregnancies occurred throughout the 1-year use in this study. The continuation rate was 20%. Irregular bleeding was the major cause of termination. The major side effect was also irregular bleeding. Nevertheless, DMPA in older women is a safe and effective contraceptive. DMPA is a contraceptive akterbatuve fir women aged above 35 with contraindications to combination oral contraceptives.

Effects of clomiphene citrate on the endometrium of regularly cycling women.

OBJECTIVE: To study the effects of clomiphene citrate (CC) on the endometrium of regularly cycling women. DESIGN: Prospective, controlled study. SETTING: Department of Obstetrics and Gynaecology, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand. PATIENT(S): Thirty healthy, regularly cycling, female volunteers. INTERVENTION(S): All volunteers were studied for two consecutive cycles, one control cycle and one CC-treated cycle. Clomiphene citrate (100 mg/d) was given on days 3-7 of the CC-treated cycles. Ultrasonography was performed daily to assess ovulation. Ultrasonography and endometrial biopsy were performed, and blood samples were obtained for determination of E2 and progesterone levels 7 days after ovulation in both the control and CC-treated cycles. MAIN OUTCOME MEASURE(S): Histologic dating, morphometric analysis, and ultrasonographic appearance and thickness of the endometrium. RESULT(S): Histologic dating and ultrasonographic appearance and thickness of the endometrium were similar in the control and CC-treated cycles, but morphometric parameters were different. The number of glands per square millimeter and the mean diameter of the glands were lower in the CC-treated cycles than in the control cycles, but the number of vacuolated cells per 1,000 glandular cells was higher. CONCLUSION(S): Clomiphene citrate has effects on the endometrium of regularly cycling women, as demonstrated by a reduction in glandular density and an increase in the number of vacuolated cells.

Effects of the etonogestrel-releasing contraceptive implant (Implanon on parameters of breastfeeding compared to those of an intrauterine device.

Eighty healthy single births born at a gestational age of 259-294 days were studied in an open, non-randomized, group comparative fashion. The mothers were on average 6 weeks postpartum, healthy, and fully breastfeeding at the start of treatment. Forty-two mothers elected to use the etonogestrel-releasing implant, Implanon, while 38 chose use of a non-hormone medicated intrauterine device (IUD). One month after implant placement, the dose of etonogestrel ingested by the infants via breast milk was 19.86 ng/kg/day, which decreased to 10.45 ng/kg/day at the end of the study period (month 4). The volume of breast milk production was not affected by the use of Implanon. There were no significant differences between groups in milk content of total fat, total protein, and lactose. The timing and quantity of supplementary feedings did not differ between the two groups. Growth of the infants was analyzed by treatment and gender. For the girls, no differences between groups were seen for body weight, body length, and head circumference. The same applied to the boys except for a somewhat larger, although not statistically significant, increase in body weight for boys whose mother used Implanon. There was a low incidence of intercurrent illnesses in the infants of both groups. None of the conditions was of a serious nature. From the present study, we conclude that Implanon did not change the volume and composition of breast milk. The low concentration of etonogestrel ingested by the infant was not associated with adverse effects.

The effect of mefenamic acid on controlling irregular uterine bleeding secondary to Norplant use.

The aim of this double-blind, placebo-controlled study was to evaluate the effect of mefenamic acid and placebo on controlling irregular uterine bleeding secondary to Norplant use. A total of 67 Norplant users attending the Family Planning Clinic of Chulalongkorn Hospital all had irregular bleeding. These women were randomly allocated into two groups. A total 34 users received mefenamic acid, 500 mg twice a day for 5 days, and placebos were given to the other 33 in the same manner. The total days of bleeding and spotting and the percentage of women in whom bleeding was stopped were analyzed in weeks 1 and 4. The percentage of subjects in whom bleeding was stopped during week 1 after initial treatment was significantly higher in the mefenamic acid group than the placebo group (76%, 27%; p < 0.001). In the follow-up period (4 weeks after initial treatment), a bleeding-free interval of > 20 days was found in 68% of the subjects treated with mefenamic acid and 33% treated with the placebo; the mean number of bleeding/spotting days was lower with mefenamic acid treatment (11.6 and 17.2 days; p < 0.05). The difference was statistically significant. It is concluded that mefenamic acid was more effective than placebo in short-term control of irregular bleeding and spotting associated with Norplant use.

PIP: This double-blind, placebo controlled study evaluates the effect of mefenamic acid and placebo on controlling irregular uterine bleeding secondary to Norplant use. A total of 67 Norplant users attending the Family Planning Clinic of Chulalongkorn Hospital who had irregular bleeding were divided into two groups. About 34 users received mefenamic acid, 500 mg twice a day for 5 days; placebos were given to the other 33 in the same manner. The total days of bleeding and spotting and the percentage of women in whom bleeding was stopped were analyzed in weeks 1 and 4. The percentage of subjects in whom bleeding was stopped during week 1 after initial treatment was significantly higher in the mefenamic acid group than the placebo group (76% vs. 27%; p 0.001). In the follow-up period (4 weeks after initial treatment), a bleeding-free interval of 20 days was found in 68% of the subjects treated with mefenamic acid and 33% treated with the placebo; the mean number of bleeding/spotting days was lower with mefenamic acid treatment (11.6 and 17.2 days; p 0.05). The difference was statistically significant. Therefore, mefenamic acid was more effective than placebo in short-term control of irregular bleeding and spotting associated with Norplant use.

Effects of DMPA on weight and blood pressure in long-term acceptors.

The study of effects on weight and blood pressure in long term DMPA acceptors is reported. The objectives were to study body weight and blood pressure changes in long term DMPA users compared with intrauterine device (IUD) acceptors. A total of 50 healthy women who had been using DMPA for 120 months were compared with 50 IUD acceptors who had been using an IUD for 120 months. Age, parity, income, body weight, and blood pressure at the initiation of contraception were matched. The mean +/- SD body weight at 120 months in the DMPA and IUD groups were 60.9 +/- 7.5 kg and 62.1 +/- 9.3 kg. No difference in mean body weight was demonstrated. The blood pressure change between DMPA and IUD acceptors also was not different. It is suggested that long term DMPA use does not have unfavorable effects on weight or blood pressure.

Prevention of mother-to-child transmission of HIV in Thailand: physicians' attitudes on zidovudine use, pregnancy termination, and willingness to provide care.

We administered a survey to Thai physicians, using regular mail, on their attitudes and practices regarding zidovudine (ZDV) use and pregnancy termination in HIV-infected pregnant women. We surveyed their willingness to care for these patients as well. In 1997, 79.5% of 480 respondents reported that they did not routinely use perinatal ZDV prophylaxis. Predictors of failure to use ZDV found to be significant in our logistic regression model included practice outside of Bangkok (odds ratio [OR] = 2.0), belief that ZDV is not cost effective (OR = 2.5), unfamiliarity with AIDS Clinical Trials Group (ACTG) 076 results (OR = 2.5), and failure to screen for HIV routinely (OR = 4.9). Elective abortion for HIV-infected women was advocated by 45.3% of respondents. Factors associated in multivariable analysis with this preference included specialty training in obstetrics/gynecology (OR = 1.8), practice inside Bangkok (OR = 2.0), male gender (OR = 1.9), and treatment of < or =2 HIV-infected patients yearly (OR = 1.8). A significant proportion of respondents described themselves as unwilling to perform pelvic examinations (19.2%), vaginal deliveries (30.7%), or cesarean deliveries (39.5%) on women who were known to be infected with HIV. We conclude that many Thai obstetric providers are reluctant to care for HIV-infected women, do not routinely use perinatal ZDV prophylaxis, and prefer to terminate pregnancies among HIV-infected patients. Physician education concerning the value of HIV screening and antiretroviral therapy in HIV-infected pregnant women is needed urgently in Thailand.

Uterine histopathologic changes after Cu-Fix intrauterine device insertion.

A study of uterine histopathologic changes after the insertion of the Cu-Fix intrauterine device (IUD) was carried out at the Obstetrics and Gynecology Department, Faculty of Medicine, Chulalongkorn University. Ten patients, who had cold conization for a suspicious Papanicolaou smear, were fitted with the Cu-Fix IUD. All patients were diagnosed as having carcinoma-in-situ of the cervix and were scheduled for hysterectomy at 6 weeks postconization. Preoperative ultrasonography showed the IUD anchoring at the uterine fundus, which corresponded with posthysterectomized findings. At the anchoring site of the nylon knot, which serves as a small retention body in the fundus, slight mononuclear cells infiltration in the myometrium was found in only one patient. However, in the endometrium, there was infiltration of mononuclear cells as well as a few plasma cells during the proliferative phase of the cycle. Evidence of local foreign body reaction was found in all patients. No patient had symptoms or signs of pelvic infection.

PIP: A study conducted at Chulalongkorn University in Bangkok, Thailand, investigated uterine histopathologic changes in 10 women fitted with the Copper (CU)-Fix IUD after cold conization for a suspicious Papanicolaou smear. All 10 women were diagnosed with carcinoma-in-situ of the cervix and underwent hysterectomy 6 weeks after IUD insertion. The findings of preoperative ultrasonography for localization of the IUD were compared with hysterectomized specimens, with emphasis on the anchoring site of the device's nylon knot. Slight mononuclear cell infiltration in the myometrium was observed in only 1 woman; normal findings were seen in the remaining patients. Histopathologic analysis revealed diffuse mononuclear cells as well as plasma cell infiltration during the proliferative phase of the menstrual cycle in all 10 women. This finding showed evidence of foreign body reactions similar to those described after insertion of other types of IUDs. No patient had signs or symptoms of pelvic infection. Overall, these results confirm there is no increased risk of uterine infection when the IUD is fixed in the muscle of the fundus.

Twelve-month comparative multicenter study of the TCu 380A and ML 250 intrauterine devices in Bangkok, Thailand.

The long-term effectiveness of the copper-bearing intrauterine device (IUD) has been documented. This paper reports 12-month results from a multiyear comparative study of the Copper T (TCu) 380A and Multiload (ML) 250 IUD in Bangkok, Thailand, among 1396 women. Continuation of the assigned IUD was relatively high after 12 months of use, with continuation rates of 90.17 and 87.54 per 100 women, respectively. Whereas the accidental pregnancy rate was higher for the ML 250 IUD than for the TCu 380A IUD (1.0 and 0.2 per 100 women, respectively), this difference was not considered statistically significant (p < 0.69). The rate of IUD expulsion was significantly higher among women using the ML 250 IUD than for women using the TCu 380A IUD (4.61 and 2.40 per 100 women, respectively, p = 0.05).

PIP: The performance of the Copper T 380A and Multiload 250 IUDs over a 4-year period were compared in a prospective study of 1396 women from Bangkok, Thailand, who were randomly assigned to be fitted with 1 of the 2 devices. This paper presents the findings from the first 12 months (1995-96) of the study. At insertion, 8-10% of women in both groups reported mild pelvic pain. After 12 months of use, the continuation rate was 90.2% for the Copper T 380A and 87.5% for the Multiload 250 device. Menstrual problems were the most common complaint during the follow-up period; such disturbances--primarily spotting and dysmenorrhea--were reported by 59.1% of Copper T 380A users and 44.4% of women in the Multiload 250 group. The accidental pregnancy rate after 12 months was higher, but nonsignificantly, among Multiload 250 users (1.0/100 women) than Copper T 380A acceptors (0.2/100 women). The IUD expulsion rate was significantly higher among Multiload 250 acceptors (4.61%) than users of the Copper T 380A (2.4%). The higher efficacy, lower risk of expulsion, and longer life span (10 years) of the Copper T 380A compared to the Multiload 250 IUD suggest this is an ideal method for women who desire long-term protection against pregnancy but do not wish to be sterilized.

Menstrual problems and side effects associated with long-term TCu 380A IUD use in perimenopausal women.

The study assessing menstrual problems and side effects associated with long-term TCu 380A intrauterine device (IUD) use in perimenopausal women is reported. Fifty perimenopausal TCu 380A IUD acceptors who had IUD inserted after age 40 and used IUD at least 36 months were recruited. The mean age of acceptors at time of insertion was 44.2 years with an average parity of two live births. The mean body weight at insertion was 62.13 kg. Most of the bleeding patterns were regular cycles. Intermenstrual bleeding and pelvic pain were side effects most often reported. No pregnancies, pelvic inflammatory disease, or IUD expulsions occurred during the follow-up period. This study suggests that the use of TCu 380A IUD in perimenopausal women is safe and effective.

PIP: Menstrual problems and side effects associated with long-term Copper T 380A use in perimenopausal women were investigated in a follow-up study of 50 Thai women who had the IUD inserted after 40 years of age (average, 44.2 years) and used the device for at least 36 months. All study participants had their IUD inserted at the family planning clinic of the Faculty of Medicine, Chulalongkorn University, in Bangkok, Thailand, and were followed at 6-month intervals. Their average parity was 2 live births. The numbers of women with irregular menstrual cycles at 12, 24, and 36 months after IUD insertion were 7 (14%), 11 (22%), and 15 (30%), respectively. Intermenstrual bleeding and pelvic pain--the most common side effects--were experienced by 15 (30%) and 9 (18%) women, respectively, during 36 months of follow up. No pregnancies, pelvic inflammatory disease, or IUD expulsions occurred and there were no significant changes in body weight or blood pressure. These findings suggest that TCu 380A use is both safe and effective up to menopause.

Premarital counseling clinic at Chulalongkorn Hospital.

BACKGROUND: The premarital counseling clinic at Chulalongkorn Hospital was established in 1978. The characteristics and sexual background were reviewed. AIM: To study characteristics, sexual background and choices of contraceptions of premarital couples attending the premarital counseling clinic at Chulalongkorn Hospital during the past ten years, (1988-1998). DESIGN: Descriptive study. MATERIAL AND METHOD: Two hundred couples (men (M) and women (W)) attending the premarital clinic at Chulalongkorn Hospital from July 1988 to January 1998 were recruited in the study. The counseling program included medical counseling, sex education and family planning counseling. The information of couples was recorded by the Family Planning Unit staff and the residents. RESULTS: The mean age was 31.5 +/- 4.3 yrs. (M), 28.9 +/- 3.8 yrs. (W). Most of the couples had a bachelor's degree education (61.5%--M; 72%--W). Most of them were employees (64.0%--M; 60.0%--W), had an income of 10,000-20,000 baht per month (39.0%--M; 38.0%--W) were Buddhist 97.0 per cent (M), 93.0 per cent (W). There were only 4 couples who had an abnormal physical examination. 85.5 per cent of the men had had sexual experience before while it was only 23.0 per cent in women. Most of the men had frequent masturbation 3-4 times/month (31.5%) and most of the women had no masturbation (86.0%) at all. Most of the couples (71.5%) chose to have contraception (contraceptive pill 57.5% and condom 20.0%). CONCLUSION: Premarital counseling should be adjusted to the background of the couples. Most couples had a high income and education. Sex counseling is important for couples especially women. The propagation of premarital clinic encourages further study and to outreach the general population of Thailand.

PIP: This study aims to review the characteristics, sexual background, and the choice of contraception among premarital couples attending the premarital counseling clinic at Chulalongkorn Hospital in Thailand. The study recruited 200 couples attending the premarital clinic from July 1988 to January 1998, which had a counseling program that included medical counseling, sex education, and family planning counseling. Most of the participants had a bachelor's degree education and a Buddhist religion. 39% of males and 38% of females had an income of 10,000-20,000 baht per month. Some couples had abnormal physical examinations such as undescended testes and cases of varicococle. About 85.6% of men had sexual experiences before marriage compared to 23% of females. Most couples (71.5%) chose to have contraception, such as contraceptive pill (57.5%) and condom (20%). Findings suggest that premarital counseling should be adjusted to the background of the couples, and sex education should focus more on women since they have lesser sexual experience before marriage as compared to men.

The GyneFix implant systems for interval, postabortal and postpartum contraception: a significant advance in long-term reversible contraception. International Study Group on Intrauterine Drug Delivery.

Intrauterine contraception has a number of important advantages over other forms of contraception and remains, therefore, an important method of birth control. However, side-effects and other drawbacks have reduced its overall acceptance. Also misconceptions and lack of updated scientific knowledge among the potential users and providers are major obstacles to the widespread use of intrauterine contraception. Ideally, an intrauterine device (IUD) should prevent pregnancy effectively, be well tolerated, not become displaced or expelled over time, cause a minimum of side-effects, be long-lasting, have a strictly local effect, and be easy to insert and remove. A group at the University of Ghent, Belgium, the International Study Group on Intrauterine Drug Delivery, has developed, since 1985, a totally new concept in order to improve current intrauterine contraceptive efficacy and enhance tolerance, by creating a harmonious relationship between the uterine cavity and the contraceptive 'foreign body'. The new concept (GyneFix) consists of a non-biodegradable suture thread made of surgical 00 monofilament polypropylene on which six copper tubes are threaded, providing a total surface area of 330 mm2. The upper and lower tubes are crimped onto the thread to keep the tubes in place. The upper extremity of the thread is provided with a knot which serves as an anchor. The knot is implanted in the myometrium of the uterine fundus with a specially designed insertion instrument, thereby permanently securing the device in the uterine cavity. Since the initial clinical investigations, over 10,000 woman years of experience and up to 10 years' follow-up in international multicenter, non-comparative and comparative clinical trials have been collected. The clinical material also included a large number of nulligravid and nulliparous women. Due to the design characteristics of the GyneFix and its anchoring in the uterine fundus, an optimal tolerance and almost complete absence of expulsion were obtained. The constant release of copper ions in the upper part of the uterine cavity results in the high effectiveness of the anchored device. The effectiveness is higher than in the high-load conventional copper IUDs which have a risk of becoming displaced, partially or totally expelled in 10% or more (nulliparous women), resulting in a significant number of accidental pregnancies. The absence of frame and, as a consequence, its flexibility, explain the low incidence of side-effects and the very low incidence of complications, such as pelvic inflammatory disease and ectopic pregnancies. This new concept could be a major step forward in the acceptance of intrauterine contraception worldwide and increase its popularity. This article reviews the experience with the new concept for interval, postabortal and postpartum contraception.

The effect of transdermal oestradiol on bleeding pattern, hormonal profiles and sex steroid receptor distribution in the endometrium of Norplant users.

The most common side-effect and reason for discontinuation with Norplant use is bleeding disturbance. The aim of this study was to investigate whether the 6 week application of a patch which released 100 micrograms/day oestradiol would reduce the number of abnormal bleeding days or eliminate the problem. Another objective was to find out the correlation between the bleeding pattern and endometrial concentrations of oestrogen receptor (ER) and progesterone receptor (PR). Of 98 Norplant users, 34 patients had normal bleeding patterns and 64 patients had abnormal bleeding patterns. An oestradiol patch or a placebo patch were randomly used to treat 33 and 31 women with abnormal bleeding respectively. There was a clinical improvement in the oestradiol group compared with the placebo group, although this was not statistically significant. There were no correlations between PR and ER concentration and the serum oestradiol, progesterone, levonorgestrel and sex hormone-binding globulin concentrations. Significantly increased mean immunostaining scores of stromal PR were observed in those Norplant users whose endometrium had an atrophic histological appearance. The serum oestradiol concentration did not show a significant change after treatment with the oestradiol patch compared with the placebo patch.

PIP: The potential of an estradiol patch (100 mcg/day for 6 weeks) to reduce the menstrual disturbances associated with progestogen-only contraception was investigated in 98 Norplant users. Of the 64 subjects reporting abnormal bleeding, 33 were given an estradiol patch and 31 received a placebo patch; the 34 Norplant users with normal bleeding patterns served as controls. Clinical improvement was recorded in 23 estradiol patch and 13 placebo patch subjects, a nonsignificant difference. Ovarian activity, demonstrated by fluctuating high levels of estrogen, occurred in most Norplant users, but without ovulation. Serum levonorgestrel concentrations ranged from 1000 to 1500 pmol/l, with no significant differences according to group. Sex hormone-binding globulin (SHBG) levels were low (range, 20-50 nmol/l), again with no significant group differences. Both levonorgestrel and SHBG concentrations were steadier in women with normal bleeding patterns. Histology revealed that endometrial specimens from Norplant users were more atrophic than proliferative. Significantly increased mean immunostaining scores of stromal progesterone receptor were noted in Norplant users whose endometrium appeared atrophic. Also observed were low estrogen receptor concentrations in both glandular and stromal compartments. Overall, these findings suggest that progestogen-related bleeding abnormalities are related to the bioavailability of estrogen and progesterone receptors in the endometrium rather than histological changes.

Trabecular bone in long-term depot-medroxyprogesterone acetate users.

A cross-sectional study was designed to determine trabecular bone density in 75 long-term depot-medroxyprogesterone acetate (DMPA) users (> 3 yr) matched with non-DMPA users by age, body mass index (18-25), limitation of age (< 45 yr), and body weight (< 60 kg). The long-term DMPA cases were divided into 3 groups according to duration of injectable contraceptive use. Neither cases nor controls had a smoking or chronic alcohol consumption history. Cases and controls were matched by age. Trabecular bone of the femoral neck were assessed by X-ray and interpreted by a single-blinded radiologist. Trabecular bone patterns were graded according to Singh's Index. Blood collection for determination of estradiol, prolactin, calcium, phosphorus, and medroxyprogesterone acetate were performed in cases and controls. Venous blood was taken at twelfth week of injection of DMPA and within 5 days after menstrual bleeding cessation in the controls. Mean trabecular bone in the cases was 5.5 +/- 0.6 (range 4-6). It was not statistically different from that in the controls (mean 5.5 +/- 0.6, range 2-6). No statistically significant difference of serum, calcium, phosphorus, prolactin, and estradiol was seen in the cases when compared to controls at mid follicular phase of normal menstrual cycle. Serum MPA of individual case at twelfth week of injection was 4.1 +/- 1.1 nmol/l. In conclusion, trabecular bone density in long-term DMPA users were not statistically different from normal menstruating women who have not received injectable DMPA.

PIP: A cross-sectional study was designed to determine trabecular bone density in 75 long-term depot-medroxyprogesterone acetate (DMPA) users ( 3 years) matched with non-DMPA users by age, body mass index (18-25), limitation of age ( 45 years), and body weight ( 60 kg). The DMPA cases were divided into 3 groups. Group 1 contained women who had used injectable contraceptives for 3-5 years; group 2 comprised women who had used DMPA for 6-7 years; and group 3 consisted of women who had used injectables for more than 7 years. Volunteers received 150 mg (3 ml) of DMPA every 12 weeks. Neither cases nor controls had a smoking or chronic alcohol consumption history. Cases and controls were matched by age. Trabecular bones of the femoral neck were assessed by X-ray and interpreted by a single-blinded radiologist. Trabecular bone patterns were graded according to Singh's Index. Determination of estradiol, prolactin, calcium, phosphorus, and DMPA in blood was performed in cases and controls. Venous blood was taken at the 12th week of injection of DMPA and within 5 days after menstrual bleeding cessation in controls. The mean serum level for calcium ranged from 9.3 to 10.1 mg% and 3.2 to 3.5 mg% for phosphorus. The mean serum level for estradiol in the 3 DMPA user groups ranged from 122.9 pmol/l to 167.7 pmol/l compared to 141.9 pmol/l to 195 pmol/l in controls. Mean trabecular bone in Group 3 of cases (n = 25) was 5.5 +or- 0.6. It was not statistically different from that in the controls (n = 49) (mean 5.5 +or- 0.6). There were no statistically significant differences in serum calcium, phosphorus, prolactin, and estradiol levels in cases compared to controls at the mid-follicular phase of normal menstrual cycle. Individual serum MPA at the 12th week of injection was 4.1 +or- 1.1 nmol/l. Trabecular bone density in long-term DMPA users was not statistically different from normal menstruating women who had not received injectable DMPA.

Intrauterine contraception.

Currently 85 million women use an intrauterine device (IUD), making it the most widely used, reliable, reversible contraceptive method worldwide. Although the exact mechanisms by which copper-bearing IUDs produce contraceptive action are not completely defined, recent evidence indicates that they act primarily to prevent sperm from fertilizing ova. The future of the IUD is brighter than it has been for the past 20 years. The latest generation of IUDs, such as the TCu 380A (Paragard, GynoPharma, Somerville, NJ), are safer and more effective than ever. In World Health Organization large, multicenter trials, pregnancy rates for the TCu 380A are 1.0, 1.4, 1.6, and 1.8 at 3, 5, 7, and 9 years of use, respectively. The ectopic pregnancy rates and removal for pelvic inflammatory disease are very low. The device may soon be the major IUD available in most countries. The acceptability of IUD use can be increased by good clinical management, sympathetic counseling, careful client selection, proper device selection, careful insertion, timing of insertion, and regular follow-up with quick access to medical care.

PIP: 85 million women worldwide use IUDs. Most live in China (60 million), with another 14 million living in other developing countries and the remaining 11 million living in developed countries. It appears that IUDs mainly prevent pregnancy by causing a foreign body response in the myometrium which consists of increased vascular permeability, edema, and stromal infiltration of leukocytes, neutrophils, mononuclear cells, and macrophages. Another possible mechanism is biochemical changes. Each family planning provider should ask a client about her contraceptive needs, obtain a social and medical history, and inform her about various contraceptives. If the client chooses the IUD, the provider should provide her with her all the relevant information (e.g., insertion procedure, side effects, warning signs of grave complications, time for IUD replacement, and return visits). This helps her to relax during insertion and makes insertion less painful., The IUD is best suited for women who have at least 1 child and access to medical care, are in a monogamous relationship, and whose menstrual period is normal. Copper releasing IUDs, especially the TCu 380A has the lowest pregnancy and expulsion rates and is effective for 6-8 years. Only trained health workers should insert IUDs and, in many developing countries, lower level health workers insert them. A training program developed by the Johns Hopkins Program for International Education in Gynecology and obstetrics and tested in Thailand achieves competent insertion by nurse-midwives after only 5 insertions. IUD insertion can occur at any time during the menstrual cycle. Postpartum insertion is safe, effective, acceptable, and does not affect lactation. Expulsion is more likely with postpartum insertion than with interval insertion, however. Proper IUD placement is high in the fundus. Good IUD clinical management also includes sympathetic follow-up care.

A comparative clinical trial of Copper T 220 C and Alza T IPCS 52 intrauterine devices in Thai women.

Two IUDs (Copper T 220 C and Alza T IPCS 52) were comparatively studied by randomized insertions in 200 Thai women who attended the Family Planning Clinic at the Department of Obstetrics and Gynecology, Faculty of Medicine, Chulalongkorn University. Point estimates of the pregnancy rate and rate of removal for bleeding and pain at 18 months were lower for the copper device than for the Alza T IPCS 52, but neither these nor any other pertinent event rates reached statistical significance. Study of the Alza device was halted before the completion of 2 years because reports from other centres indicated an unacceptable pregnancy rate beyond 2 years.

The effects of three techniques of tubal occlusion on ovarian hormones and menstruation.

PIP: This study compared the effects of 3 tubal occlusion techniques on ovarian steroid secretion and menstrual patterns in 48 Thai women aged 20-35 years. 17 women underwent laparoscopic tubal electrocautery, 18 were sterilized with the laparoscopic Falope Ring, and 13 underwent suprapubic tubal ligation. Serum estrogen and progesterone were assessed every 5 days during the 1st 3 poststerilization months; subjects were followed for a total of 12 menstrual cycles after the procedure. Poststerilization patterns and levels of serum estradiol and progesterone were similar to those of a normal menstrual cycle, regardless of the type of tubal sterilization. 20% of cycles in the laparoscopic tubal electrocautery group, 13% in the Falope Ring group, and 8% in the suprapubic tubal ligation group revealed progesterone peak levels below 4 ng/ml. In each cycle of the 3 groups, serum estradiol creased to more than 150 pg/ml before the rise in progesterone. No abnormal uterine bleeding was noted. In addition, there were no significant changes in menstrual duration or flow in the 1-year follow up period with any of the 3 methods. Of the 3 methods investigated, laparoscopic tubal cautery resulted in the most frequent episodes of corpus luteal insufficiency.^ieng

A comparative study of Lippes loop and Delta loop intrauterine devices in early postpartum.

Two IUDs (Delta loop, Lippes loop D) were randomly inserted in 260 postpartum women within 2-36 hours after delivery by uterine-packing forceps. The Delta loop was designed with the intention of lowering the expulsion rate compared with the standard Lippes loop. The analysis of the data indicated that the expulsion rate of the Delta loop was as high as the Lippes loop D at the one-month follow-up (Delta loop 24.1%, Lippes loop 23.9%). The comparison of other pertinent event rates also showed no significant differences.

Laparoscopic tubal electrocoagulation for sterilization: 5000 cases.

Five thousand cases of laparoscopic tubal electrocoagulation were performed for voluntary interval sterilization in outpatient Thai women from January 1974 through June 1978. Immediate complications occurring during surgery resulted from mesosalpingeal hemorrhage, which was successfully managed by omental packing with or without repeated electrocoagulation. The overall failure rate was 0.40%. The authors find this method of tubal electrocoagulation for fertility management to be reliable and safe as an outpatient procedure and to provide rapid convalescence.

PIP: 5000 cases of laparoscopic tubal electrocoagulation were performed for voluntary interval sterilization in outpatient Thai women from January 1974 through June 1978. Immediate complications occurring during surgery resulted from mesosalpingeal hemorrhage, which was successfully managed by omental packing with or without repeated coagulation. The overall failure rate was .40%. This method of tubal electrocoagulation for fertility management was found to be reliable as an outpatient procedure and provide rapid convalescence. Only .6% of the Thai women were under age 20; 50.3% were aged 21-30; 46% were 31-40; and, 3.2% were over 41. Only .3% were nulliparous; 1.5% were para 1, 31% were para 2; 31.5% were para 3; and, 18% were para 4. The rest were para 5 or higher. 53% lived in Bangkok; the rest lived in rural areas. Over 99% requested the procedure as a means of voluntary permanent contraception. The overall incidence of complications was 3.08%. Most of these (95 cases or 1.90%) resulted from active mesosalpingeal hemorrhage. There were 20 pregnancies following the procedure: 9 cases of luteal phase pregnancy and 9 of electrocoagulation of an inappropriate anatomical structure. 2 cases of ectopic pregnancy occurred 4 years after the original procedure. Complications often resulted from difficulty with trocar insertion which could be avoided by a slight change of the trocar insertion angle. Only 1 case with bowel injury occurred in this series.