Radiofrequency volumetric thermal ablation of fibroids: a prospective, clinical analysis of two years' outcome from the Halt trial.

BACKGROUND: Although most myomas are asymptomatic, quality of life is compromised for many women with uterine fibroid disease. Twelve-month outcomes from the Halt Trial have been reported in the literature. Here we analyze the clinical success of radiofrequency volumetric thermal ablation (RFVTA) of symptomatic uterine fibroids at two years of follow up. METHODS: Prospective, multicenter, outpatient interventional clinical trial of fibroid treatment by RFVTA in 124 premenopausal women (mean age, 42.4 ± 4.4 years) with symptomatic uterine fibroids and objectively confirmed heavy menstrual bleeding (≥160 to ≤500 mL).Outcome measures included: subject responses to validated questionnaires, treatment-emergent adverse events, and surgical re-intervention for fibroids at 24 months postprocedure. Continuous and categorical variables were summarized using descriptive statistics and means and percentages. Comparisons between visits were based on t-tests using repeated measures models. P-values < 0.05, adjusted for multiplicity, were statistically significant. RESULTS: One hundred twelve subjects were followed through 24 months. Change in symptom severity from baseline was -35.7 (95% CI, -40.1 to -31.4; p<.001). Change in health-related quality of life (HRQL) was 40.9 (95% CI, 36.2 to 45.6; p < .001). HRQL subscores also improved significantly from baseline to 24 months in all categories (concern, activities, energy/mood, control, self-consciousness, and sexual function) [p<.001]. Six patients underwent surgical re-intervention for fibroid-related bleeding between 12 and 24 months providing a re-intervention rate of 4.8% (6/124). CONCLUSION: Radiofrequency volumetric thermal ablation of myomas significantly reduces symptom severity and improves quality of life with low surgical re-intervention through 24 months of follow up.

Effect of hormonal contraceptives during breastfeeding on infant's milk ingestion and growth.

OBJECTIVE: To measure infants' breast milk intake and infant growth when their mothers initiated either combined oral contraceptive (COC), levonorgestrel-releasing intrauterine system, or etonogestrel-releasing implant, or copper intrauterine device (IUD) as a reference group. DESIGN: Prospective trial. SETTING: University-based hospital. PATIENT(S): On postpartum day 42, 40 women initiated a contraceptive method according to their choice. INTERVENTION(S): Deuterium (D2O; 0.5 g/kg mother's weight) was ingested by mothers on postpartum days 42, 52, and 63 as a marker of total body fluid. MAIN OUTCOME MEASURE(S): Infants' milk intake from 42 to 63 postpartum days was assessed by measurement of D2O levels in infants' saliva and infant growth by measuring their body weight, height, and tibia length. Women recorded all infant feed and changes of diapers wet with urine. Breastfeeding continuation was assessed at 6 months postpartum. RESULT(S): Infant mean milk intake, mean growth increase, mean number of breastfeeding episodes, daily wet diaper changes, and mean duration of exclusively breastfeeding (~5 months) were similar in the four groups. CONCLUSION(S): Use of a COC, the two progestin-only contraceptives, or copper IUD did not affect the amount of infant milk intake and growth up to 9 weeks of age. The incidence of full breastfeeding and breastfeeding continuation was similar with contraceptive hormonal use and no use. CLINICAL TRIALS REGISTRATION NUMBER: NCT01388582.

Effect of subcutaneous depot-medroxyprogesterone acetate (DMPA-SC) on serum androgen markers in normal-weight, obese, and extremely obese women.

BACKGROUND: The effects of subcutaneous depo-medroxyprogesterone acetate (DMPA-SC) injection on androgenic markers in obese women have not previously been studied. STUDY DESIGN: Five normal-weight [body mass index (BMI)=18.5-24.9 kg/m²], five obese (BMI=30-39.9 kg/m²) and five extremely obese (BMI≥40 kg/m²) women were recruited for this prospective experimental study in which 104 mg DMPA-SC was administered at baseline and 12 weeks later. Serum levels of total testosterone (T), androstenedione (A), dehydroepiandrosterone sulfate (DHEAS), 3α-androstanediol glucuronide and sex hormone-binding globulin (SHBG) were quantified by immunoassay methods at baseline and at 13 and 26 weeks following the first injection; free T was calculated. RESULTS: At baseline, obese women had lower levels of A and SHBG and higher total and free T levels than normal-weight women. There were a statistically significant decrease in the levels from baseline to week 26 among all three BMI classes for A, total T and SHBG (p≤.03) and an increase from baseline to week 26 in weight (p=.02). In addition, there was a statistically significant decrease in DHEAS from baseline to week 13 among all three BMI classes (p=.01), which was not sustained at week 26 (p>.1). Overall, the three groups responded similarly to all changes at week 13, and there were no statistically significant differences between groups at any time point (p≥.06). CONCLUSION: DMPA-SC use in normal-weight, obese and extremely obese women can decrease serum androgen markers.

The effects of hormonal contraceptive use among women with viral hepatitis or cirrhosis of the liver: a systematic review.

BACKGROUND: This report evaluates the effects of hormonal contraceptive use among women with viral hepatitis or cirrhosis of the liver. METHODS: PubMed and Cochrane databases were searched from inception to June 2008 for publications that examined the use of hormonal contraceptives among women with viral hepatitis or cirrhosis of the liver. RESULTS: Six studies met the inclusion criteria. In one study of acute hepatitis, combined oral contraceptive (COC) use did not affect duration of hospitalization or successful disease resolution. The remainder of the studies examined chronic hepatitis or its sequelae. Women recovered from hepatitis experienced transaminase elevation with COC use which resolved after 4 weeks in one study or increased slightly over 6 months in another study. Hepatitis B virus carriers using COCs had similar transaminase levels as nonusing carriers over 6 months. Studies of chronic hepatitis C infection demonstrated no influence of COC use on progression or severity of liver fibrosis or development of hepatocellular carcinoma. CONCLUSION: Data from one study suggest that COCs do not affect the course of acute hepatitis. Limited data from studies on chronic hepatitis or its sequelae suggest that COC use does not affect the rate of progression or severity of cirrhotic fibrosis, the risk of hepatocellular carcinoma in women with chronic hepatitis, or the risk of liver dysfunction in hepatitis B virus carriers.

Breastfeeding and contraception use among women with unplanned pregnancies less than 2 years after delivery.

OBJECTIVE: To examine breastfeeding and contraceptive use after the lactational amenorrhea method (LAM) criteria were no longer met. METHODS: Two hundred and thirty-three parous Egyptian women with unplanned pregnancies less than 2 years after delivery completed a questionnaire examining breastfeeding practice and contraceptive use. RESULTS: The majority of women (81.5%) with unplanned pregnancies within 2 years of delivery were breastfeeding at conception. Of these women, 36.3% had used a method of contraception other than LAM compared with 60.5% of women who had weaned (P<0.05). Among the breastfeeding women, 61.2% failed to use contraception because they believed breastfeeding would prevent pregnancy. CONCLUSION: Breastfeeding women with unplanned pregnancies were less likely to have used contraception than women who had weaned, suggesting that prolonged breastfeeding contributes to unmet contraceptive need.