The frameless copper IUD (GyneFix) and the TCu380A IUD: results of an 8-year multicenter randomized comparative trial.

BACKGROUND: Clinical performance of the frameless copper IUD (GyneFix), designed to reduce side effects related to the frame of conventional IUDs, and TCu380A was compared. STUDY DESIGN: Randomized Multicenter randomized comparative trial. Parous women requesting and eligible to use IUD were admitted in 21 centers in eight countries in 1989-1993 and followed-up for up to 8 years. RESULTS: Two thousand twenty-seven women were randomized to the frameless IUD and 2036 to TCu380A; 43 insertions of the frameless IUD failed and none for TCu380A. First-year expulsion rate of the frameless IUD was 5.3 (95% CI: 4.4-6.4) per 100 and 2.5 (95% CI: 1.9-3.3) for the TCu380A; second- through eighth-year expulsion rates were not different. First-year pregnancy rates for the frameless IUD and TCu380A were 1.3 (95% CI: 0.9-2.0) and 0.5 (95% CI: 0.3-0.9), respectively; second- through eighth-year cumulative pregnancy rates were 1.2 (95% CI: 0.7-1.9) and 2.5 (95% CI: 1.8-3.4), respectively. The 8-year cumulative rates of ectopic pregnancy and IUD removal for pain were lower for the frameless IUD than for TCu380A. Removals for other reasons were not different. CONCLUSIONS: The frameless IUD had more insertion failures, expulsions and pregnancies in the first year than TCu380A, but fewer pregnancies from the second through the eighth year, and by 8 years had fewer ectopic pregnancies and removals for pain.

The prevalence of lower genital tract infections among ante-natal care (ANC) clinic patients in two central hospitals, Vientiane, Lao People's Democratic Republic.

This study of lower genital tract infections in pregnant women attending antenatal clinics in Vientiane, Lao PDR is a response to the reported rapid increase in the number of HIV infections in neighboring countries, and is a recognition of the important role of reproductive tract infections in facilitating HIV transmission. This cross-sectional study determines the prevalence of lower genital tract infections among 500 antenatal attendees (gestational age < or = 20 weeks) attending two hospitals serving urban areas in Vientiane, between September 2001 and March 2002. Most participants were housewives (64.4%) and government workers (16.0%). Their husbands were mainly government officers (31.4%), laborers or farmers (30.2%), and businessmen (12.4%). Sixty-four percent reported a past history of "any vaginal complaints" with 44.2% having sought treatment. Candida spp had the highest prevalence of all infections (27.0%), followed by bacterial vaginosis (14.4% by Amsel's criteria and 22.0% by Nugent's score), C. trachomatis (10.2% by nucleic acid hybridization and 9.6% by PCR), T. vaginalis (1.8%), and N. gonorrhoeae (0.8%), but no syphilis serological markers. Taken in conjunction with other surveillance data from the same period, this study indicates an opportunity to prevent epidemic spread into the community of both sexually transmitted disease and HIV by appropriate preventative programed activities, including treatment services targeted at higher risk community groups.

Assessment of menstrual blood loss in Belgian users of a new T-shaped levonorgestrel-releasing intrauterine system.

OBJECTIVE: This study was conducted to evaluate the effect of a T-shaped levonorgestrel-releasing intrauterine system (Femilis, LNG IUS) on the amount of menstrual blood loss (MBL) in women with and without menorrhagia. The daily release of the LNG IUS was approximately 20 mug. MATERIALS AND METHODS: In 60 Belgian women, less than 48 years of age at study enrollment, using the Femilis LNG IUS for 4 to more than 30 months, MBL was assessed with the visual assessment technique. Twenty-eight women had normal menstrual periods at baseline (menstrual score <185) and 32 women had idiopathic menorrhagia (menstrual score > or =185). RESULTS: Menstrual blood loss scores dropped significantly during the observation period in all women except one. The median menstrual score at baseline in women with normal menstrual bleeding was 140 (range 80-160) and dropped to a median score of 5 (range 0-150) at follow-up, a decrease of 96%. In the 32 women with menorrhagic bleeding at baseline, menstrual flow dropped from a median score of 232 (range 185-450) at baseline to a median score of 3 (range 0-50) at follow-up, a decrease of 99%. Twenty women developed amenorrhea (33%): 10 in the group of women with normal menstruation and 10 in those women with menorrhagia. Most of the remaining women had oligomenorrhea requiring the use of a few panty-liners only. In one woman, MBL did not decrease, thus requiring further evaluation. CONCLUSION: The impact on MBL of this new 20 mug/day LNG-releasing IUS confirms other studies with devices releasing the same or lower amounts of LNG. The strong endometrial suppression is the principal mechanism explaining the effect on MBL. The strong effect on MBL of this contraceptive method offers an important health benefit and improvement in quality of life, particularly in women with heavy bleeding and anemia, as other treatment modalities are less effective, more costly, more invasive or not readily available.

Prevalence of lower genital tract infection among women attending maternal and child health and family planning clinics in Hanoi, Vietnam.

To determine the prevalence of lower genital tract infection (LGTI) with Candida spp, Trichomonas vaginalis, Neisseria gonorrhoeae, Chlamydia trachomatis, and bacterial vaginosis among symptomatic and asymptomatic women attending maternal and child health and family planning (MCH/FP) clinics in Hanoi, Vietnam. A multi-centered, cross-sectional descriptive study stratified by reported symptoms of vaginal discharge was carried out in three MCH/FP clinics among 1,000 women aged 18-44 years in 1998. Of these, 89.1% lived in Hanoi, 97.6% were currently married, and 99.2% had only one sexual partner in the past 12 months. Regarding their contraceptive use, 28.2% did not use any contraception, 25.6% used an intrauterine device (IUD), 22.8% used condoms, and 23.4% used other methods. The overall prevalence of Candida spp was 11.1% (95% CI = 9.1-13.1%); T. vaginalis, 1.3% (95% CI = 0.6-2.0%); no gonococcal infection was found; the prevalence of C. trachomatis was 4.4% (95% CI = 3.1-5.7%); and of bacterial vaginosis, 3.5% (95% CI = 2.4-4.6%). The presence of LGTI was not associated with reported symptom of vaginal discharge. LGTI was common among married and monogamous women attending MCH/FP clinics in Hanoi, of whom many used IUDs and may have an increased risk of complications in the presence of LGTI. The lack of association between symptoms and laboratory-confirmed infection underscores the challenge of diagnosing LGTI when laboratory testing is not available.