Use of a low-dose oral contraceptive preparation: report of a study

A study was carried out among 100 healthy married women using the low-dose oral contraceptive (OC) Ovostat E, also known as Ovostat 28, comprised of 1.0 mg lynestrenol and 0.05 mg ethinylestradiol, and confined to the 1st 12 cycles. Patients were divided into 2 groups: 1) 35 who had never taken OCs or had discontinued 3 months prior to the study, and 2) 59 who were taking OCs prior to the study. All were seen 1 month after the initial visit and thereafter once every 3 months, and were told to record their bleeding patterns. Average age of group 1 was 24 and of group 2 was 26. All had at least 1 living child. No pregnancies occurred, bleeding patterns were not unusual although there was a high incidence (4.9%) of light breakthrough bleeding or spotting in the 1st (21.9%) and 2nd (14.6%) cycle of group 1. No significant differences in the side effects between the 2 groups was noted except for nausea (10% higher in group 1 during the 1st 4 cycles). Incidence of headache increased in group 1 but markedly decreased in group 2. Weight and blood pressure showed no significant change. At the end of the year 78 women were still on medication (others had dropped out for personal or medical reasons). In general, side effects were no different from those with normal dose OCs. Although breakthrough bleeding existed in group 1, it was mild and well tolerated and could be avoided by starting the patient on a high dose preparation a few months before starting the low dose OC. Ovostat E is found to offer increased safety resulting from the low dose of active constituents.     

Comparison of culdoscopic and laparoscopic tubal sterilization.

The growing number of women requesting interval sterilization (apart from term delivery or abortion procedures) necessitates the re-evaluation of traditional surgical procedures. A total of 800 women--the first 400 women undergoing culdoscopic and laparoscopic tubal sterilization procedures at Siriraj Hospital in Bangkok, Thailand--evaluate the appropriateness of the two sterilization procedures for use in interval sterilization programs. No serious operative complications occurred in either group. However, the rate of postoperative complications was considerably higher for the culdoscopic group than for the laparoscopic group. Hospitalization was required for only a small percentage of the patients and most had resumed their normal activities within two days of the operation. This study indicates that both procedures are effective and may be safely performed on an outpatient basis without general anesthetics and with minimal discomfort for the patients.     

Identification and characterization of mutations in FANCL gene: A second case of Fanconi anemia belonging to FA‐L complementation group

Fanconi anemia (FA) is a rare autosomal recessive or X‐linked disorder characterized by aplastic anemia, cancer susceptibility and cellular sensitivity to DNA crosslinking agents. Eight FA proteins (FANCA, FANCB, FANCC, FANCE, FANCF, FANCG, FANCL and FANCM) and three non‐FA proteins (FAAP100, FAAP24 and HES1) form an FA nuclear core complex, which is required for monoubiquitination of the FANCD2‐FANCI dimer upon DNA damage. FANCL possesses a PHD/RING‐finger domain and is a putative E3 ubiquitin ligase subunit of the core complex. In this study, we report an FA patient with an unusual presentation belonging to the FA‐L complementation group. The patient lacks an obvious FA phenotype except for the presence of a café‐au‐lait spot, mild hypocellularity and a family history of leukemia. The molecular diagnosis and identification of the FA subgroup was achieved by FA complementation assay. We identified bi‐allelic novel mutations in the FANCL gene and functionally characterized them. To the best of our knowledge, this is the second reported case belonging to the FA‐L complementation group. © 2009 Wiley‐Liss, Inc.     

Microdose intravaginal levonorgestrel contraception: a multicentre clinical trial. I. Contraceptive efficacy and side effects. World Health Organization. Task Force on Long-Acting Systemic Agents for Fertility Regulation

A multicentre clinical trial, including 19 centres in 13 countries, assessed the contraceptive efficacy and clinical acceptability of a Silastic 382 vaginal ring releasing 20 micrograms of levonorgestrel for at least 90 days. A total of 1005 women entered the study and 8176.74 woman-months of experience was gathered. The rate of intrauterine pregnancy at one year of use was 3.6 per 100 women (95% confidence interval 2.2-5.0), and of ectopic pregnancy, 0.2% (one case). The principal reasons for discontinuation were menstrual disturbances (17.2% at one year), vaginal symptoms (6.0%) and repeated expulsion of the ring (7.1%). The pregnancy rate with this 20 micrograms levonorgestrel-releasing vaginal ring compares favourably with that of a low estrogen combination oral contraceptive tested by WHO and is less than half that of a progestogen-only oral contraceptive in a WHO randomized study. It is concluded that the WHO intravaginal ring releasing an average of 20 micrograms of levonorgestrel per 24 hours is an effective method of contraception for at least one year of use.     

A randomized,double-blind study of two combined oral contraceptives containing the same progestogen,but different estrogens

An investigation correlating scanning electron microscopic observations with sperm penetration tests carried out on cervical mucus under the influence of low-dose continuous progestogen (Norgestrienone) is presented. The results demonstrate that such type of contraceptive is involved in drastic alterations of mid-cycle cervical mucus at the macromolecular level. The meshwork which constitutes the infrastructure of the cervical secretion appears to be greatly tightened as a result of the treatment, thus giving the woof a general appearance typical of cervical mucus in the late luteal phase. The immobilizing effect of such modified mucus on spermatozoa is demonstrated and the duration of effectiveness after the administration of a last pill on the morning of day 13 is determined.     

Effects of hormonal contraceptives on milk volume and infant growth. WHO Special Programme of Research, Development and Research Training in Human Reproduction Task force on oral contraceptives

WHO conducted a three-centre study in Hungary and Thailand to evaluate the effects of hormonal contraception on lactation and infant growth. Women choosing oral contraceptives were randomly assigned to a combined oral contraceptive containing 30ug ethinyl estradiol and 150ug levonorgestrel (N=86) or a progestin-only preparation containing 75ug dl-norgestrel (N=85). Identical packaging and treatment schedules allowed double-blind observation. One-hundred-and-eleven women using no contraception or non-hormonal methods acted as controls. In the two Thai centres 59 women using depot-medroxyprogesterone acetate formed an additional comparison group. All subjects were healthy women with normal deliveries, whose infants had normal birth weights and satisfactory growth in the neonatal period.

Breast milk volume was determined by pump expression using standardized procedures. Information was obtained on nursing frequency and supplementation, infant growth and morbidity. Pretreatment observations at 6 weeks post-partum were used as a baseline, and subjects were followed-up at 9, 12, 16, 20 and 24 weeks post-partum.

Women using combined oral contraceptives had a decline in milk volume within 6 weeks of initiating treatment, whereas no significant decrease was observed in the other treatment groups. After 18 weeks of treatment, combined oral contraceptive users experienced a 41.9% decline in milk volume, compared to 12.0% with progestin-only minipills and 6.1% in the non-hormonal controls. The prevalence of complementary feeding and withdrawals due to inadequate milk supply were comparable in the four treatment groups. However, data were not available on the daily amounts of complementary feeds. There were no significant differences in growth of infants between treatment groups. Thus, women may have compensated for declines in milk volume by more supplementary feeding or by more prolonged and intense suckling episodes.

We conclude that 30 ug estrogen-containing combined oral contraceptives impair milk secretion, but in the selected healthy group of mothers and children studied with the prevailing level of supplementary feeding, this did not adversely affect infant growth.     

Sterilization by spring clip: a report of 1000 cases with a 6-month follow-up.

In September 1972, clinical trials of a spring-loaded clip for laparoscopic sterilization were begun and extended to a number of centers in the United States and overseas. As of March 1974, more than 1000 patients had undergone the procedure, usually performed under local anesthesia in an outpatient setting, with no fixed contraindications. Complications and pregnancy rates based on a preliminary 6-month follow-up are presented. Complications due to application of the clip appeared to be limited to postoperative cramps lasting 24 to 48 hours (26% of the patients). No ectopic pregnancies were reported. Pregnancies, when corrected for unsuspected pregnancies and misapplication of the clip, occurred in 2 of these first 1000 patients. The difficulties and relative contraindications learned from this unselected series and the advantages over electrocagulation techniques are discussed.