Menstrual Diary Research Articles

The menstrual cycle and its effect on the immune status of female endurance runners

Twenty highly trained, eumenorrhoeic female endurance runners were studied over three consecutive menstrual cycles. Average training distance per week, total years training and mood states were recorded throughout the three cycles. Salivary progesterone and menstrual cycle diaries were recorded over the first two cycles to identify luteal phase onset and the presence of any menstrual irregularities. Saliva samples were collected daily over the third cycle for analysis of immunoglobulin A (IgA) concentration and secretion and saliva flow rate. Twoway analysis of variance (ANOVA) revealed no significant differences in mood states across the phases of the menstrual cycle ( P > 0.05). Training logs indicated that training did not alter throughout the 3 month study. One-way ANOVArevealed no significant differences in IgA concentration ( P = 0.92), secretion rate ( P = 0.84) or saliva flow rate ( P = 0.95) across the phases of the menstrual cycle. Pearson's product-moment correlation revealed no relationship between IgA concentration and progesterone between the phases of the cycle ( r = 0.39). We conclude that, in ovulatory female endurance runners whose physical and emotional stress are stable, IgA concentration is not significantly affected by fluctuations in progesterone during the menstrual cycle.

A Multicenter Evaluation of Endometrial Ablation by Hydro ThermAblator and Rollerball for Treatment of Menorrhagia

Study Objective To compare results of endometrial ablation using the Hydro ThermAblator (HTA) and rollerball Design Prospective, randomized study (Canadian Task Force classification I). Setting Nine private practice and university centers in the United States Patients Two hundred seventy-six women with menorrhagia due to benign causes. Intervention Endometrial ablation with the HTA (187 women) or rollerball (89). Measurements and Main Results Menstrual diaries were kept for 2 weeks and 3, 6, and 12 months after treatment. Reduction in diary scores to 75 or lower at 12 months was considered a success. For patients treated and followed according to protocol, success rates were 77% for HTA and 82% for rollerball. Amenorrhea rates at 12 months were 40% and 51%, respectively. Conclusion Endometrial ablation with the HTA is safe and effective. It offers an advantage over rollerball ablation of being an office-based procedure, which reduces anesthesia requirements and obviates problems of fluid absorption.

Continuous administration of 100 μg levonorgestrel and 20 μg ethinyl estradiol for elimination of menses: a randomized trial

Objective: To evaluate the efficacy and safety of continuous 20-μg oral contraceptive pill use, compared with cyclic use of the same pill, for the elimination of menses as measured by daily menstrual bleeding diaries. Methods: This was an open-label prospective randomized trial to compare 28-day–cycle monthly arm (MA) subjects with continuous arm (CA) subjects. Outcomes measured are bleeding and spotting, pill-taking compliance, method satisfaction, estrogen symptoms, and hemoglobin. Endometrial histology and ultrasonographic measurements are being collected on a subset of subjects at randomization and after nine study cycles are completed. Results: Beginning February 2000, 94 subjects enrolled for a ‘wash-in‘ cycle. Eighty subjects were then randomized either to MA or CA study assignment. The ongoing study has 75 continuing subjects, with 57 women on their fourth or subsequent pill cycle in the study. Reasons for study discontinuation among MA subjects have included irregular bleeding and weight gain, and some were lost to follow-up; among CA subjects, reasons for study discontinuation have been a desire to conceive and bloating. Conclusion: This randomized trial will compare the experience of women taking continuous low-estrogen oral contraceptives with the experience of women undergoing a monthly hormonal withdrawal period. We will present detailed bleeding and spotting profiles for women during their first 6 months of continuous oral contraceptive use. Rates of amenorrhea, infrequent bleeding, and irregular bleeding will be reported to confirm the efficacy and acceptability of menstrual suppression.

Menstrual patterns and risk of adult-onset diabetes mellitus

We examined the association between menstrual patterns and risk of developing adult-onset diabetes in a prospective study of 668 white, college-educated women who completed menstrual diaries throughout their reproductive years. We calculated summary measures of cycle length and variability and bleeding duration for ages ⩽22, 23–27, 28–32, and 33–37 years. The analysis included 35,418 person-years of follow-up and 49 self-reported cases of diabetes (median age at diagnosis, 63 years). There was no association between diabetes risk and age at menarche, mean cycle length, cycle variability, or frequency of long cycles (>42 days). Longer bleeding periods in the mid- and late reproductive years were somewhat associated with an increased risk of diabetes (adjusted rate ratio 1.4, 95% confidence interval 1.0–1.8 per day increase in bleeding duration for menses during ages 28–32). These results do not support the association of long or irregular menstrual cycles with post-menopausal diabetes incidence, but do suggest a possible association of longer bleeding duration with subsequent onset of diabetes.

Luteal function declines after laparoscopic sterilization by Hulka or Filshie clips

We evaluated the influence of laparoscopic sterilization by Hulka or Fishie clips on corpus luteum function. Changes in corpus luteum function were evaluated in 46 women, before and after sterilization by Hulka (n = 22) or Filshie clips (n = 24). The mean age of the participants was 37 years (range 31–43 years). All women were healthy with regular menstrual cycles. Serum progesterone (P) was measured in one cycle before, and 3 and 12 months after the sterilization on cycle day 20–24. Endometrial biopsies were performed in the luteal phase before and one year after the procedure. The women measured the basal body temperature daily and kept a menstrual diary. The luteal phase P concentrations declined after the sterilization and the values were at the lowest level 3 months after the procedure (27.9 ± 14.3 nmol/L vs. 18.7 ± 13.4 nmol/L, = 0.0016). The values seemed to have recovered by 12 months (23.0 ± 14.0 nmol/L, = 0.114 vs. baseline). Endometrium tended to be out-of-phase more frequently 1 year after the sterilization than before the surgery (= 0.065). Laparoscopic tubal sterilization is associated with an increased risk of luteal phase deficiency. However, the change may be only temporary in nature.

Hysteroscopic Endometrial Ablation Using Free Heated Saline for the Treatment of Menorrhagia

Study Objective To assess the safety and efficacy of hysteroscopic endometrial ablation using controlled intrauterine instillation and circulation of heated (90° C) saline. Design Phase II clinical study (Canadian Task Force classification II-2). Setting Preliminary study performed in an outpatient ambulatory surgery center of a university hospital. Patients Twenty women with menorrhagia of benign causes. Intervention Hysteroscopic endometrial ablation. Measurements and Main Results There were no complications. At no time did fluid leak from the fallopian tubes or cervix during treatment. Six patients had concurrent laparoscopy to measure serosal temperatures and to observe fimbriae directly during the 10-minute treatment. Serosal and endocervical temperatures were not elevated. Eighteen women kept evaluable menstrual diaries for 2 months before and 12 months after surgery. Ten women (55.6%) became amenorrheic, four (22.1%) hypomenorrheic, and three (16.7%) returned to normal periods after 12 months of follow-up. One woman (5.6%) reported a 75% decrease in menstrual flow but continued to be menorrhagic by definition. One patient subsequently underwent hysterectomy for simple endometrial hyperplasia. Conclusion This procedure appears to be a safe method of globally ablating the endometrium, resulting in effective treatment of menorrhagia.

Analysis of menstrual diary data across the reproductive life span Applicability of the bipartite model approach and the importance of within-woman variance

The nature of variability in menstrual function has not been adequately described or quantified across the reproductive life span. This article evaluates the applicability of the bipartite model approach to the analysis of menstrual data and the relative importance of within-woman variability across the reproductive life span using data from the Tremin Trust data, a large prospective study in which women maintained menstrual diaries throughout their reproductive life. We first consider how the boundaries of the Gaussian portion of the distribution change with age, and reflect upon the implications of these distribution changes for definitions of normal cycling. We next estimate the change in mean cycle length, in between- and within-woman variance and in the probability of having a nonstandard cycle across the reproductive life span. Finally, we characterize the dynamics of menstrual cycling within women over time at various points in the reproductive life span.

Effect of SR49059, an orally active V1a vasopressin receptor antagonist, in the prevention of dysmenorrhoea

To investigate the clinical effect of SR49059 when given shortly before the onset of menstruation as a preventative treatment of dysmenorrhoea. A double-blind, randomised, placebo-controlled, cross-over trial in complete block design (three periods, three treatments). A clinical research organisation in Paris, France. Women aged 18-35 years suffering from primary dysmenorrhoea. In each of three menstrual cycles, women reported to the study centre and were given a daily dose of either placebo, 100 mg or 300 mg SR49059 from a minimum of 4 hours up to a maximum of three days before the onset of bleeding and/or menstrual pain. If this did not control the pain, women were allowed once a day to take a second dose of study treatment providing that at least 4 hours had passed since the first drug intake. Intensity of menstrual pain recorded by means of a visual analogue scale. Rating of symptoms of dysmenorrhoea (mainly back and pelvic pain) in relation to functional capacity (Sultan score). Self-assessment of menstrual blood loss in a menstrual diary record. Analysis of intensity of menstrual pain, as recorded by visual analogue scale and Sultan pain score (back and pelvic pain) during the first 24 hours of dysmenorrhoea, showed a dose-related effect of SR49059. The 300 mg dose of SR49059 was significantly more effective than placebo. Similarly, a dose-related effect of SR49059 was shown on total Sultan score. SR49059 was well tolerated and no significant effect on the bleeding pattern was noted. This study showed for the first time a therapeutic effect of an orally active vasopressin V1a receptor antagonist in the prevention of dysmenorrhoea. Further studies are required to examine effect mechanisms and determine effective doses.

Intrainvestigator comparison of efficacy of endometrial ablation by two different methods

Objective: To compare results of endometrial ablation by rollerball and hydrothermablation among nine clinical sites to determine whether the efficacy of either technique varied from site to site and therefore from surgeon to surgeon.Methods: A blind, retrospective comparison of 276 patients, ages 30–50 years, who underwent endometrial ablation in nine sites with either rollerball or hydrothermablation. Results were based on the analysis of 6 months of Janssen menstrual diaries completed by the subjects. Comparison of percent success (defined as eumenorrhea or better) to percent failure was calculated for each method and then compared among the nine sites.Results: The success rate of rollerball endometrial ablation appeared to vary from site to site more than the success rate of hydrothermablation, which was more consistent from site to site.Conclusions: The success of endometrial ablation by rollerball varied among surgeons, whereas the success of hydrothermablation was more consistent and therefore likely less dependent on the technique or experience of the surgeon.

Seveso Women’s Health Study: a study of the effects of 2,3,7,8-tetrachlorodibenzo-p-dioxin on reproductive health

Although reproductive effects of 2,3,7,8-tetrachlorodibenzo-p-dioxin (TCDD) exposure have been reported in numerous investigations of animals, studies of this association in humans are limited. In 1976, an explosion in Seveso, Italy exposed the surrounding population to among the highest levels of TCDD recorded in humans. The relatively pure exposure to TCDD and the ability to quantify individual level TCDD exposure from sera collected in 1976 for the Seveso cohort affords a unique opportunity to evaluate the potential dose-response relationship between TCDD exposure and a spectrum of reproductive endpoints. The Seveso Women’s Health Study (SWHS) is the first comprehensive study of the reproductive health of a human population exposed to TCDD. The primary objectives of the study are to investigate the relationship of TCDD and the following endpoints: (1) endometriosis; (2) menstrual cycle characteristics; (3) age at menarche; (4) birth outcomes of pregnancies conceived after 1976; (5) time to conception and clinical infertility; and (6) age at menopause. Included in the SWHS cohort are women who were 0–40 yr old in 1976, who have adequate stored sera collected between 1976 and 1980, and who resided in Zones A or B at the time of the accident. All women were interviewed extensively about their reproductive and pregnancy history and had a blood draw. For an eligible subset of women, a pelvic exam and transvaginal ultrasound were conducted and a menstrual diary was completed. More than 95% of the women were located 20 yr after the accident and roughly 80% of the cohort agreed to participate. Data collection was completed in July 1998, serum TCDD analysis of samples for analysis of endometriosis as a nested case-control study was completed in October 1998, and statistical analysis of these data should be completed in early 1999. Serum samples are now being analyzed in order to relate TCDD levels with the remaining reproductive outcomes.

The relationship of physical trauma and surgical stress to menstrual dysfunction.

To evaluate the incidence and pattern of menstrual dysfunction in reproductive age group women suffering acute musculoskeletal trauma, 198 women between 15 and 50 years of age admitted consecutively into an acute orthopaedic unit were recruited over a 6-month period. The patients were then followed up for 6 months with menstrual diaries to compare their menstrual pattern with their preadmission status. Excluding those with significant menstrual problems before admission, the menstrual pattern remained normal in 135 (68%) (EM), while 12 (6%) developed polymenorrhoea (PM), and 51 (25%) had oligomenorrhoea or amenorrhoea (OAM) within the 6-month observation. The three groups did not differ in their mean age, body mass index, parity or age of menarche, but previous cycle lengths were shortest in the PM group (25.4 days, SD 7.64) (p<0.05) and history of amenorrhoea in the previous one year was most common in the OAM group (p<0.025). Univariate analysis showed the incidence of moderate to major trauma,operative treatment, longer operative time, general anaesthesia, blood transfusion and immobilisation were significantly higher in the PM and OAM groups compared to the unchanged group (p<0.05). A logistic regression model showed that general anaesthesia and longer surgical operations remained significantly related to the development of menstrual dysfunction. We conclude that the pattern of menstrual dysfunction after acute orthopaedic trauma appeared to be dictated by the woman's pre-existing menstrual characteristics and the stress of surgical treatment.

Retrospective self-report compared with menstrual diary data prospectively kept during the menopausal transition

Objective To investigate the reliability of self-report of menstrual frequency and flow changes in the context of determining menopausal status categories, using data from the longitudinal phase of the Melbourne Women's Midlife Health Project (MWMHP).Methods Women reporting at interview at least one menstrual period during the previous 3 months are assigned pre- or perimenopausal status according to their responses to questions about changes in menstrual frequency and flow. For a sample of 72 such women, menstrual diary information was converted into standardized scores measuring change in frequency and flow of menses during the 2 years prior to interview. These scores, coded into categories, were used to derive measures of the sensitivity, specificity and predictive values of the interview responses.Results Self-report of change in menstrual frequency and flow have low sensitivity to measures based on prospectively kept menstrual diaries.Conclusions Retrospective self-report at interview of changes in menstrual frequency and flow should not be regarded as reliable measures of actual changes in cycle parameters.

Interim Results of the American Vesta Trial of Endometrial Ablation

Abstract Study Objective. To compare results of endometrial ablation using the Vesta system compared with resection and rollerball. Design. Multicenter, prospective, randomized, controlled study (Canadian Task Force classification I). Setting. Private practice and academic center. Patients. Women with menorrhagia documented by menstrual diaries who failed or refused hormonal therapy and who had no major uterine organic lesions. Interventions. Vesta endometrial ablation or traditional endometrial resection and rollerball ablation. Measurements and Main Results. Both groups achieved excellent control of menorrhagia. Conclusion. Vesta is an attractive alternative to traditional methods of endometrial ablation.(/)

Interim results of the American Vesta trial of endometrial ablation

To compare results of endometrial ablation using the Vesta system compared with resection and rollerball. Multicenter, prospective, randomized, controlled study (Canadian Task Force classification I). Private practice and academic center. Women with menorrhagia documented by menstrual diaries who failed or refused hormonal therapy and who had no major uterine organic lesions. Vesta endometrial ablation or traditional endometrial resection and rollerball ablation. Both groups achieved excellent control of menorrhagia. Vesta is an attractive alternative to traditional methods of endometrial ablation. (J Am Assoc Gynecol Laparosc 6(1):45-49, 1999)

Vaginal bleeding patterns among users of a single implant contraceptive containing 3-ketodesogestrel (Implant&lt;sup&gt;®&lt;/sup&gt;)

ABSTRACTING & INDEXING

Cognitive therapy for premenstrual syndrome: A controlled trial

The aim of this study was to evaluate the effectiveness of cognitive therapy (CT) as a psychological treatment for premenstrual syndrome (PMS), by comparison with a waitlist control group. Women meeting selection criteria for PMS were randomly allocated to one of two treatment groups: (i) an immediate treatment group, who received 12 weekly sessions of individual CT; or (ii) a waiting list group who recorded symptoms of PMS for a length of time equivalent to the duration of an individual treatment in the immediate treatment group. General practitioners and gynecologists referred women who were complaining of distressing and disabling emotional and physical symptoms in the second half of the menstrual cycle, as verified by 2 months of prospective diary recording. Assessments of the women’s psychological and social functioning were made on entry to the study, 2 months later, and at the end of the treatment period. This design allows evaluation of the efficacy of CT relative to any spontaneous remission that may have occurred as a consequence of the passage of time, the keeping of menstrual diaries, interview, and self-rated assessments. Results indicated that CT was significantly more effective than assignment to the waitlist group. Diary measures and self-report questionnaires indicated an almost complete remission of psychological and somatic symptoms and of impairment of functioning. It is concluded that CT for PMS is associated with substantial improvements that cannot be attributed to the passage of time or the completion of the diary and other assessments.

Thermal Balloon and Rollerball Ablation to Treat Menorrhagia: A Multicenter Comparison

Objective: To compare the clinical efficacy and safety of a thermal uterine balloon system with hysteroscopic rollerball ablation in the treatment of dysfunctional uterine bleeding. Methods: Two hundred fifty-five premenopausal women were treated in a randomized multicenter study comparing thermal uterine balloon therapy with hysteroscopic rollerball ablation for the treatment of menorrhagia. Preprocedural and postprocedural menstrual diary scores and quality-of-life questionnaires were obtained. Twelve-month follow-up data are presented on 239 women. Results: Twelve-month results indicated that both techniques significantly reduced menstrual blood flow with no clinically significant difference between the two groups as reflected by return to normal bleeding or less (balloon 80.2% and rollerball ablation 84.3%). Multiple quality-of-life questionnaire results were also similar, including percent of patients highly satisfied with their results (balloon 85.6% compared with rollerball 86.7%). A 90% decrease in diary scores was seen in more than 60% of patients in both groups. Procedural time was reduced significantly in the uterine balloon therapy group. Intraoperative complications occurred in 3.2% of the hysteroscopic rollerball patients, whereas no intraoperative complications occurred in the thermal balloon group. Conclusion: In the treatment of dysfunctional uterine bleeding, uterine balloon therapy is as efficacious as hysteroscopic rollerball ablation and may be safer.

Combined laboratory and diary method for objective assessment of menstrual blood loss

To develop an objective measurement system for menstrual blood loss applicable in clinical practice. One hundred and fifty-six patients were enrolled in a randomized trial of the treatment of menorrhagia in all five gynecology departments of the university teaching hospitals in Finland. Correlation between venous blood hemoglobin concentration (Hb) and absorbance at 564 nm (A564) was investigated in experiments with blood samples. Amount of collected menstrual blood and menstrual diary data were analyzed. Hb concentration and A564 of the blood were linearly correlated (r=0.99). One hundred and fifty-four women (99%) returned used sanitary protection and menstrual diaries. On average, 12% (range 0-57%) of menstrual blood was lost during collection. The median amount of blood recovered from sanitary protection was 89 ml (range 14-724 ml), with 58% (n=90) of the women exceeding 80 ml per cycle. When the spilled blood was taken into account, the corresponding figures were 104 ml (range 15-724 ml) and 66% (n= 101). The spectrophotometric measurement of venous blood in the conventional alkaline hematin method can be replaced by measurement of Hb concentration. All blood incompletely collected should be recorded. Objective measurement of menstrual blood loss can be applied in routine clinical practice.

Linear Mixed Models with Heterogeneous within-Cluster Variances

This paper describes an extension of linear mixed models to allow for heterogeneous within-cluster variances in the analysis of clustered data. Unbiased estimating equations based on quasilikelihood/pseudolikelihood and method of moments are introduced and are shown to give consistent estimators of the regression coefficients, variance components, and heterogeneity parameter under regularity conditions. Cluster-specific random effects and variances are predicted by the posterior modes. The method is illustrated through an analysis of menstrual diary data and its properties are evaluated in a simulation study.

Intracervical and fundal administration of levonorgestrel for contraception: endometrial thickness, patterns of bleeding, and persisting ovarian follicles

To study the prevalence of persisting ovarian follicles and to assess the endometrial changes and patterns of vaginal bleeding over 1 year of use of a 20 micrograms/24 h levonorgestrel-releasing intracervical contraceptive device. Prospective, randomized study. Two family planning clinics in Helsinki, Finland. Women requesting intrauterine hormonal contraception. Insertion of a levonorgestrel-releasing intracervical contraceptive device into the cervical canal (group 1, n = 151) or fundally into the uterine cavity (group 2, n = 147) for contraception. Transvaginal ultrasonography of the ovaries and endometrium at insertion and 3, 6, and 12 months after insertion. Data on bleeding were collected using menstrual diary cards. Persisting ovarian follicles were found in < 8% of women. In both groups, the amount of endometrial tissue decreased significantly in 3 months. The incidence of amenorrhea during the 1st year was higher in the fundal insertion group. The number of persisting follicles was low. Follicles resolved within 6 to 8 weeks. No association was found between persisting follicles and problems of bleeding. Compared with intracervical insertion, fundal insertion resulted in more uniform endometrial suppression and fewer days of bleeding and spotting.