Pictorial blood loss assessment chart in the evaluation of heavy menstrual bleeding: diagnostic accuracy compared to alkaline hematin.

BACKGROUND/AIMS: The pictorial blood assessment chart (PBAC) is a method for evaluation of menstrual blood loss (MBL). This study was conducted to evaluate the accuracy of the PBAC score in diagnosing MBL compared to alkaline hematin as a gold standard. METHODS: Two cohorts were constructed: 30 women who reported 'normal' menses and 170 who reported 'heavy' menses. Evaluation of menstruation was performed using the PBAC score and by alkaline hematin. RESULTS: Women who reported normal menses were younger (p = 0.071), had lower parity [median parity of 3 (range 1-6) vs. 4 (range 1-12), p < 0.001] and higher hemoglobin levels (11.1 ± 1.1 vs. 10.1 ± 1.6 g/dl, p < 0.001). PBAC scores and MBL by alkaline hematin were significantly correlated (Spearman r = 0.600, p < 0.001). The PBAC score of 150 had a κ of 0.593 (95% CI 0.480-0.687) and an area under the curve of 0.796 (95% CI 0.770-0.821). In a multivariable regression PBAC score >150, presence of blood clots and period duration >7 days were independent predicators of heavy menstrual bleeding with an overall area under the curve of 0.858 (95% CI 0.835-0.879). CONCLUSIONS: The PBAC score is a simple and accurate tool for semiobjective of MBL that can be used in clinical practice to aid the decision about treatment and follow-up.

A randomized clinical trial of a levonorgestrel-releasing intrauterine system and a low-dose combined oral contraceptive for fibroid-related menorrhagia.

OBJECTIVE: To compare the efficacy of a levonorgestrel-releasing intrauterine system (LNG-IUS) with that of a low-dose combined oral contraceptive (COC) in reducing fibroid-related menorrhagia. METHODS: In this single-center, open, randomized clinical trial, 58 women with menorrhagia who desired contraception were randomized to receive a LNG-IUS or COC. The outcomes included treatment failure, defined as the need for another treatment; menstrual blood loss (MBL) by the alkaline hematin method and a pictorial assessment chart (PBAC); hemoglobin levels; and "lost days." RESULTS: Treatment failed in 6 women (23.1%) in the LNG-IUS group and 11 (37.9%) in the COC group, for a hazard ratio of 0.46 (95% CI, 0.17-1.17, P=0.101). Using the alkaline hematin test, the reduction of MBL was significantly greater in the LNG-IUS group (90.9% ± 12.8% vs 13.4% ± 11.1%; P<0.001). Using PBAC scores, the reduction was also significantly greater in the LNG-IUS group (88.0% ± 16.5% vs 53.5% ± 5 1.2%; P=0.02). Moreover, hemoglobin levels increased from 9.7 ± 1.9g/dL to 11.7 ± 1.2g/dL (P<0.001) and lost days decreased from 8.2 ± 3.3 days to 1.3 ± 1.5 days (P=0.003) in the LNG-IUS group. CONCLUSION: Although the rate of treatment failure was similar in both groups, the LNG-IUS was more effective in reducing MBL than the COC in women with fibroid-related menorrhagia.

Levonorgestrel-releasing intrauterine system compared to low dose combined oral contraceptive pills for idiopathic menorrhagia: a randomized clinical trial.

BACKGROUND: This study compared the efficacy of the levonorgestrel-releasing intrauterine system (LNG-IUS) to low dose combined oral contraceptive pills (COC) in the management of idiopathic menorrhagia. STUDY DESIGN: A single-center, open, randomized clinical trial. One hundred twelve women complaining of excessive menstruation who desired contraception were randomized to receive LNG-IUS or COC. Treatment failure was defined as the need for medical or surgical treatment during the follow-up. Other outcomes included: menstrual blood loss (MBL) by alkaline hematin and by pictorial blood assessment chart (PBLAC), hemoglobin levels and assessment of lost days in which physical or mental health prevented participating women from performing usual activities. RESULTS: At baseline, LNG-IUS (n=56) and COC (n=56) groups were comparable in age (mean ± S.D.) (39.3 ± 6.7 vs. 38.7 ± 5.2 years, p=.637), parity (median and range) [3(1-6.4) vs.3(2-6), p=.802] and BMI (mean ± S.D.) (29.6 ± 5.9 vs. 31.1 ± 5.7 kg/m(2), p=.175). Time to treatment failure was longer in LNG compared to COC group with a total of 6 (11%) patients who had treatment failure in the LNG-IUS compared to 18 (32%) in COC group with a hazard ratio of 0.30 (95% CI, 0.15-0.73, p=.007). Using alkaline hematin, the reduction in MBL (mean ± S.D.) was significantly more in the LNG-IUS group (87.4 ± 11.3%) compared to the COC group (34.9 ± 76.9%) (p=.013). Utilizing PBLAC scores, the reduction in the LNG-IUS (86.6 ± 17.0%) group was significantly more compared to the COC group (2.5 ± 93.2%) (p<.001). In the LNG-IUS group, increase in the hemoglobin and ferritin levels (mean ± S.D.) were noted (from 10.2 ± 1.3 to 11.4 ± 1.0 g/dL; p<.001; with reduction of the number of lost days (from 6.8 ± 2.6 to 1.6 ± 2.4 days, p=.003). CONCLUSION: The LNG-IUS is a more effective therapy for idiopathic menorrhagia compared to COC.

A comparative study of the levonorgestrel-releasing intrauterine system Mirena versus the Copper T380A intrauterine device during lactation: breast-feeding performance, infant growth and infant development.

BACKGROUND: Mirena is a levonorgestrel-releasing intrauterine system (LNG-IUS) that provides highly effective and long-acting progestogen-only contraception. OBJECTIVE: The objective of this study was to analyze the possible effects of using LNG-20 microg IUS on breast-feeding performance, infant growth and infant development during the first postpartum year as compared with the Copper T380A intrauterine device (Cu T380A IUD). DESIGN: This study is a prospective, controlled and randomized trial. SETTING: The study was conducted at the Department of Obstetrics and Gynecology, Assiut University Hospital, Egypt. METHODS: Three hundred twenty lactating women asking for initiation of contraception during the early postpartum stage were assigned randomly into two groups, the LNG-20 microg IUS group (n=163) and the Cu T380A group (n=157). The insertions were done 6-8 weeks postpartum. Each participant was followed up at three monthly intervals after insertion and until the first birthday of her baby. During these visits, the breast-feeding pattern was assessed, certain infant physical growth parameters were measured and a set of infant development tests was performed. RESULTS: No pregnancy occurred in both groups. There were no significant differences in the net continuation rates between the two groups (89.3 for LNG-IUS vs. 90.9 for Cu T380A). The LNG-20 microg IUS group had comparable rates of breast-feeding continuation, complete weaning, full breast-feeding and partial breast-feeding, with the Cu-IUD group. No statistically significant differences were found between groups with regard to all infant physical growth parameters and various infant development tests. CONCLUSION: The findings of the current study confirm that the use of LNG-20 microg IUS during the first postpartum year in lactating women provides highly effective and acceptable contraception and does not negatively influence breast-feeding or the growth and development of breast-fed infants.

Effect of uniplant on liver function in Egyptian women with asymptomatic hepatitis B virus infection.

Uniplant is a single 35mm contraceptive implant releasing nomegestrol acetate with an effective life span of one year. This study was undertaken to evaluate the possible effects of three-year use of uniplant on some liver enzymes (SGPT, SGOT and GGT) in Egyptian women and to evaluate whether the past asymptomatic hepatitis B virus infection would predispose to any changes in these enzymes. This is an uncontrolled prospective study including 187 women of reproductive age who desired contraception for three years (three segments each year). They were apparently healthy on clinical assessment with no history of jaundice or liver diseases. They also had normal levels of liver function enzymes (SGPT, SGOT & GGT). Fasting blood samples were drawn at admission for assessing the levels of these liver enzymes and to detect anti-HBS antibodies as a marker of past asymptomatic hepatitis B virus infection (HBV) and HBS antigen to diagnose the chronic carrier state. The liver enzymes were measured at 6th. 12th, 18th, 24th, 30th and 36th month of use, and 3-6 months after implant removal. Out of 187 subjects enrolled 159, 83 and 33 women completed one, two and three years of Uniplant use respectively. The mean levels of SGPT, SGOT and GGT showed slight but significant elevations at the end of the first and second years of use compared to the pre-insertion levels. By the end of the third year, the elevated mean values of all enzymes gradually decreased to approach the pre-insertion levels without any significant differences. The percentage of anti-HBS antibodies positive titre due to past asymptomatic infection was 23.3% (n = 41) while HBsAg positive antigenaemia (i.e., carrier state) was 3.4%, (n = 5). In both groups of women--anti-HBS antibodies positive (n = 41) without antigenaemia and anti-HBS antibodies negative (n = 129)--the changes in the mean levels of all enzymes during uniplant use were closely similar without any statistical significance. These results demonstrated that: (1) uniplant induced slight but significant elevations in the mean levels of SGPT, SGOT and GGT these elevations were within the normal ranges, completely reversible and of doubtful clinical significance. (2) The non-carrier women who had been exposed to past asymptomatic HBV infection showed no significant effects on the studied liver enzymes compared to the normal women during long-term use of Uniplant.