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Trials Jun 2022For many women, uncomfortable and stressful symptoms accompany the menstrual cycle each month, sometimes in a debilitating manner. Previous studies have reported that...
The effect of a probiotic on gastrointestinal symptoms due to menstruation in healthy adult women on oral contraceptives: randomized, double-blind, placebo-controlled trial protocol.
INTRODUCTION
For many women, uncomfortable and stressful symptoms accompany the menstrual cycle each month, sometimes in a debilitating manner. Previous studies have reported that gastrointestinal symptoms in healthy women significantly differ by the day of the menstrual cycle, but few studies have assessed interventions intended to minimize these symptoms. Probiotics supplements have been shown to attenuate gastrointestinal symptom severity as well as self-reported feelings of stress in various populations. This study evaluates the effect of a probiotic on abdominal pain and gastrointestinal symptoms in healthy women who take an oral contraceptive, have regular menses, and typically experience these symptoms during menstruation with the primary aim being change in abdominal pain intensity related to the menstrual cycle with probiotic versus placebo supplementation.
METHODS AND ANALYSIS
In this randomized, double-blind, placebo-controlled parallel study, participants will receive either a probiotic or placebo supplement. Participants will begin answering questionnaires approximately 7 days before the start of menstruation (i.e., active bleeding), and 3 days later, they will begin consuming the study supplement for 8 weeks. The questionnaires administered will collect data about abdominal pain severity (primary outcome) and duration related to the menstrual cycle, digestive health, dietary intake, stress, and digestion-associated quality-of-life. A subgroup of women will provide weekly vaginal swabs and stool samples to examine the effect of the probiotic supplement on microbiota composition and diversity for exploratory purposes. Two-sided tests using a linear model and a type I error rate of α = 0.05 will be employed to test all hypotheses. Continuous variables will be presented as means with standard errors and categorical variables, as counts or proportions.
ETHICS AND DISSEMINATION
This study was reviewed and approved by the University of Florida Institutional Review Board 01. Written informed consent will be obtained from all participants prior to any study activities. Study findings will be disseminated at scientific conferences and publication in the trial registry or in a peer-reviewed journal. Any protocol amendments will be reported in the final manuscript of this study.
TRIAL REGISTRATION
ClinicalTrials.gov NCT04457401 . Registered prospectively on 07 July 2020. The trial was completed in December of 2021.
PROTOCOL VERSION
V4.0 (11-04-2020) TRIAL STATUS: Currently recruiting. Recruitment began in November 2020 and extend until December 2021.
Topics: Abdominal Pain; Adult; Contraceptives, Oral; Double-Blind Method; Female; Gastrointestinal Diseases; Humans; Menstruation; Probiotics; Randomized Controlled Trials as Topic; Treatment Outcome
PubMed: 35689274
DOI: 10.1186/s13063-022-06410-w -
Fertility and Sterility Jul 1992To report 15 new menarcheal women affected with nonclassical 3 beta-hydroxysteroid dehydrogenase deficiency (nonclassical 3 beta-HSD) and evaluation of glucocorticoid... (Review)
Review
OBJECTIVE
To report 15 new menarcheal women affected with nonclassical 3 beta-hydroxysteroid dehydrogenase deficiency (nonclassical 3 beta-HSD) and evaluation of glucocorticoid therapy in treated patients.
DESIGN
Diagnosis of these new patients using a standard adrenocorticotropin test. Effects of glucocorticoid therapy on clinical hormonal and sonographic features of each patient are appreciated for periods varying between 4 months and 7 1/2 years.
SETTING
All at The New York Hospital-Cornell Medical Center. The Pediatric Endocrinology Ambulatory Service; the Children's Clinical Research Center Core Laboratories; and the Department of Radiology.
PATIENTS, PARTICIPANTS
Fifteen menarcheal women (14 to 30 years of age) newly diagnosed and 10 women previously diagnosed were evaluated for symptoms of hyperandrogenism and/or irregular menses.
MAIN OUTCOME MEASURE(S)
Positive effect of glucocorticoid therapy on signs and symptoms, hormonal levels, and ovarian imaging.
RESULTS
Polycystic ovarian syndrome is noted in approximately half the cases. Glucocorticoid treatment greater than 3 months duration results in a reversal of symptoms in most cases.
Topics: 3-Hydroxysteroid Dehydrogenases; Adolescent; Adult; Androgens; Female; Glucocorticoids; Humans; Polycystic Ovary Syndrome
PubMed: 1623993
DOI: No ID Found -
BMC Women's Health Apr 2020The aim of this study was to evaluate the effect of vaginal repair in patients with cesarean section diverticulum (CSD) who had one or two previous cesarean sections...
BACKGROUND
The aim of this study was to evaluate the effect of vaginal repair in patients with cesarean section diverticulum (CSD) who had one or two previous cesarean sections (CSs).
METHODS
From January 2012 to December 2014, 248 women with CSD underwent vaginal repair surgery in Shanghai First Maternity and Infant Hospital. These included 193 women with one previous cesarean section and 55 women with two previous cesarean sections. Excision and suture of CSD was performed through a vaginal approach. The duration of menstruation, the length, width and depth of the CSD and thickness of the remaining muscular layer (TRM) were evaluated before and after surgery by transvaginal three-dimensional (3D) color Doppler ultrasound.
RESULTS
A total of 221 (89.11%) women were followed-up for more than 3 months, and 168 (67.74%) women were followed-up for more than 6 months. There were significant differences in the average duration of menstruation (7.77 ± 2.05 and 8.02 ± 2.06 days VS 13.99 ± 3.71 days), the average size of CSD (5.54*9.19*5.60 and 5.75*9.04*6.18 mm VS 7.99*12.43*6.62 mm) and the TRM (7.61 ± 2.52 and 7.60 ± 3.00 mm VS 2.51 ± 1.02 mm) after surgery compared with those figures before surgery. The results of this study reveal that vaginal repair could shorten the duration of menstruation and improve anatomical defects (P < 0.05). Moreover, there was no significant difference in the effect of clinical repair between women with one or two previous cesarean sections (P > 0.05).
CONCLUSION
In CSD patients, the clinical effectiveness of vaginal repair was equivalent between women with one or two previous cesarean sections.
Topics: Adult; Cesarean Section; China; Cicatrix; Diverticulum; Female; Humans; Pregnancy; Retrospective Studies; Treatment Outcome; Vagina
PubMed: 32326910
DOI: 10.1186/s12905-020-00940-8 -
Reproductive Biology and Endocrinology... 2006Macaques are menstruating nonhuman primates that provide important animal models for studies of hormonal regulation in the uterus. In women and macaques the decline of... (Review)
Review
Macaques are menstruating nonhuman primates that provide important animal models for studies of hormonal regulation in the uterus. In women and macaques the decline of progesterone (P) at the end of the cycle triggers endometrial expression of a variety of matrix metalloproteinase (MMP) enzymes that participate in tissue breakdown and menstrual sloughing. To determine the minimal duration of P withdrawal required to induce menses, we assessed the effects of adding P back at various time points after P withdrawal on both frank bleeding patterns and endometrial MMP expression. Artificial menstrual cycles were induced by treating the animals sequentially with implants releasing estradiol (E2) and progesterone (P). To assess bleeding patterns, P implants were removed at the end of a cycle and then added back at 12, 24, 30, 36, 40, 48, 60, or 72 hours (h) after the initial P withdrawal. Observational analysis of frank bleeding patterns showed that P replacement at 12 and 24 h blocked menses, replacement at 36 h reduced menses but replacement after 36 h failed to block menses. These data indicate that in macaques, a critical period of P withdrawal exists and lasts approximately 36 h. In other similarly cycled animals, we withdrew P and then added P back either during (12-24 h) or after (48 h) the critical period, removed the uterus 24 h after P add back and evaluated endometrial MMP expression. Immunocytochemistry showed that replacement of P during the critical period suppressed MMP-1, -2 and -3 expression along with menses, but replacement of P at 48 h, which failed to suppress mense, suppressed MMP-1 and MMP-3 but did not block MMP-2. We concluded that upregulation of MMPs is essential to menses induction, but that after the critical period, menses will occur even if some MMPs are experimentally blocked.
Topics: Animals; Female; Gene Expression Regulation, Enzymologic; Macaca; Matrix Metalloproteinases; Menstruation; Models, Biological; Progesterone; RNA, Messenger; Time Factors
PubMed: 17118170
DOI: 10.1186/1477-7827-4-S1-S6 -
Women's Health (London, England) 2024While menstruation is a physiologic process, it remains highly stigmatized. Despite the sheer number of menstruators, menstruation is a highly individualized experience,...
BACKGROUND
While menstruation is a physiologic process, it remains highly stigmatized. Despite the sheer number of menstruators, menstruation is a highly individualized experience, with wide variation in duration, symptoms, and management. This wide variability lends itself to large disparities in access to menstruation management products and subsequently the lived experience of menstruators.
OBJECTIVES
The research team sought to understand lived menstrual experiences, symptoms, management tactics, and commonly used and desired resources among 20 cisgendered women aged 18-45 years in Philadelphia.
DESIGN
This project was a qualitative research study.
METHODS
We used a collaborative, community-based participatory research approach with No More Secrets, a Philadelphia-based grassroots sexuality awareness and menstrual health hub. Semi-structured telephone interviews were used to gain insight into general menstruation-related experiences, communication, worries, and concerns, with subsequent thematic analysis via Key Words in Context approach.
RESULTS
Four themes emerged following analysis: cycle characteristics, menstruation management, coping resources, and future resources. Participants largely spoke about their menses as a negative experience, asked for more comprehensive, verified sources of information and needed greater access to menstrual management supplies.
CONCLUSION
Menstruation is a highly individualized experience with a large variety in knowledge, menstrual product use, and individual needs. Despite the individuality of menstruation, our community-based research shows that there is a dire need for interventions that promotes knowledge and access to menstrual care.
Topics: Humans; Female; Adult; Menstruation; Qualitative Research; Philadelphia; Young Adult; Adolescent; Middle Aged; Community-Based Participatory Research; Menstrual Hygiene Products; Health Knowledge, Attitudes, Practice; Adaptation, Psychological; Interviews as Topic
PubMed: 38738597
DOI: 10.1177/17455057241251975 -
Postgraduate Medical Journal May 1973A retrospective analysis has been made of 160 cases of postmenopausal bleeding. The women were at least 45 years old and the time lapse from the last menstruation was at...
A retrospective analysis has been made of 160 cases of postmenopausal bleeding. The women were at least 45 years old and the time lapse from the last menstruation was at least 2 years. The cause was a malignant neoplasm in 23·75%. The incidence of malignancy showed a definite rise with advancing age and with increasing duration of bleeding. It was nearly twice as high in women who stopped menstruation after the age of 55 years. Malignancy also seemed to be more frequent in patients with profuse bleeding and in those who had amenorrhoea lasting for 20 years or more. The most usual malignant lesions were endometrial and cervical carcinoma, the ratio of these two conditions being 1·6: 1. Oestrogen administration was the most common cause in the non-malignant group: 12·5%. No cause for bleeding could be demonstrated in 8·8%. The aetiology of postmenopausal bleeding is discussed.
Topics: Aged; Atrophy; Estrogens; Female; Humans; Menopause; Middle Aged; Uterine Cervical Neoplasms; Uterine Hemorrhage; Uterine Neoplasms; Uterine Prolapse; Vaginitis
PubMed: 4804457
DOI: 10.1136/pgmj.49.571.344 -
Transfusion Medicine and Hemotherapy :... Jun 2023Postpartum hemorrhage (PPH) is the leading cause of peripartal maternal mortality and accounts for 25% of all maternal deaths worldwide. The most common reasons of PPH...
INTRODUCTION
Postpartum hemorrhage (PPH) is the leading cause of peripartal maternal mortality and accounts for 25% of all maternal deaths worldwide. The most common reasons of PPH are uterine atony, retained placenta, or placenta accreta spectrum. Treatment of PPH depends on the etiology and corresponds to a stepwise approach, which follows the German, Austrian and Swiss guideline for the diagnosis and therapy of PPH in Switzerland. In severe ongoing PPH, hysterectomy has been the ultima ratio for many decades. Nowadays, interventional embolization of the pelvic arteries (PAE) has become a popular alternative. Besides being a highly effective minimally invasive method, PAE avoids hysterectomy with consecutively reduced morbidity and mortality. However, data on the long-term effects of PAE on fertility and menstrual cycle are scarce.
METHODS
We performed a monocentric study consisting of a retro- and a prospective part including all women who had undergone a PAE between 2012 and 2016 at University Hospital Zurich. Descriptive characteristics of patients and efficacy of PAE defined as cessation of bleeding were analyzed retrospectively. In the prospective part, all patients were contacted for a follow-up questionnaire regarding menstruation and fertility after embolization.
RESULTS
Twenty patients with PAE were evaluated. Our data showed a success rate of PAE in 95% of patients with PPH; only 1 patient needed a second, then successful, PAE. No patient needed a hysterectomy or any other surgical intervention. In our study, an association between mode of delivery and identified etiology of PPH is observed. After spontaneous delivery ( = 6), the main reason of severe PPH was retained placenta ( = 4), while after cesarean section ( = 14), uterine atony was identified in most cases ( = 8). Regarding menstruation after embolization, all women reported regular menstruation after the breastfeeding period (100%). The majority reported a regular pattern with a shorter or similar duration (73%) and lower or similar intensity (64%). Dysmenorrhea decreased in 67% of patients. Four patients planned another pregnancy, of whom only one had become pregnant with assisted reproductive technology and ended up in a miscarriage.
DISCUSSION
Our study confirms the efficacy of PAE in PPH, thus obviating complex surgical interventions and associated morbidity. The success of PAE does not depend on the primary cause of PPH. Our results may encourage the prompt decision to perform PAE in the management of severe PPH in case of failure of conservative management and help physicians in the post-interventional counseling regarding menstruation patterns and fertility.
PubMed: 37434998
DOI: 10.1159/000527614 -
Frontiers in Reproductive Health 2023Most women face multiple and co-occurring risks from unwanted pregnancy, human immunodeficiency virus (HIV) and other sexually transmitted infections (STIs) at some...
INTRODUCTION
Most women face multiple and co-occurring risks from unwanted pregnancy, human immunodeficiency virus (HIV) and other sexually transmitted infections (STIs) at some point during their lifetime. While a range of contraceptive methods exist and options for HIV prevention are increasing, to date, only male and female condoms provide multipurpose protection from both pregnancy and disease.
METHODS
From September 2017 to December 2018, 60 women from the United States and the Dominican Republic, randomized 1:1 to continuous or interrupted use and 4:1 to active vs. placebo ring, participated in a Phase I trial to assess the safety and tolerability of a three-month multipurpose intravaginal ring (IVR) containing the antiviral tenofovir and the contraceptive levonorgestrel. This study examines survey responses from all participants and qualitative data from a subset of 17 women to assess acceptability of and preferences for IVR characteristics.
RESULTS
Overall, women liked the concept of a multipurpose IVR and found it easy to insert and remove. Initial concerns about the size or thickness of the ring generally disappeared with use experience. Women weighed trade-offs between the ease of continuous use for a longer duration against concerns about hygiene and discoloration of the ring when left in place during menses. Whether randomized to continuous or interrupted use, most women found ring attributes (size, thickness, flexibility) very acceptable. They provided recommendations survey and qualitative interviews for ring modifications that would further increase acceptability. Insights into women's use experiences also suggest the need for clear counseling messages and introduction strategies that can facilitate women's choice and use of prevention methods.
DISCUSSION
Study findings suggest that a multipurpose IVR would make a valuable contribution to women's sexual and reproductive health options, and that both continuous and interrupted use strategies may be preferred.
PubMed: 37064825
DOI: 10.3389/frph.2023.1148134 -
Journal of Women's Health (2002) Jul 2022The monthly dapivirine vaginal ring provides partial protection against HIV, and a longer duration ring may reduce user burden and improve adherence. We examined... (Randomized Controlled Trial)
Randomized Controlled Trial
The monthly dapivirine vaginal ring provides partial protection against HIV, and a longer duration ring may reduce user burden and improve adherence. We examined acceptability and preference for 3-month versus 1-month rings for HIV-1 risk reduction in a phase 1 clinical trial. In Microbicide Trials Network-036/International Partnership for Microbicides 047, 49 HIV-negative participants aged 18-45 were randomized to one of two 3-month rings or the 1-month ring. Acceptability ratings were collected at enrollment, week 4, and study exit (week 13). At exit, ring preference was assessed quantitatively among all participants and a randomly selected subset of 24 participants completed in-depth interviews. Quantitative and qualitative findings were integrated to explore factors influencing acceptability and preference. Acceptability of each ring was initially moderate and increased during the trial. Ratings were lower in the 3-month ring arms than the 1-month arm at each time point, including baseline. Most participants (34/47; 72%) preferred a 3-month ring at exit; however, this proportion was significantly lower within some subgroups characterized by site, education, race/ethnicity, and experiences with ring use. Qualitative interviews revealed reservations about hygiene and safety of the 3-month ring, including discomfort with use during menses, but these were usually outweighed by its increased convenience. Both ring durations were highly acceptable at study exit. Although most participants preferred a 3-month ring, preference was more divided in certain subgroups, highlighting the benefit of offering different duration options. Providing additional support to address concerns about hygiene and safety may improve acceptability of a 3-month vaginal ring.
Topics: Anti-HIV Agents; Contraceptive Devices, Female; Female; HIV Infections; HIV Seropositivity; HIV-1; Humans; Risk Reduction Behavior
PubMed: 34665672
DOI: 10.1089/jwh.2021.0121 -
BMC Women's Health Mar 2022Premenstrual syndrome (PMS) is used to describe physical, cognitive, affective, and behavioral symptoms that affect young and middle-aged women occurring cyclically...
BACKGROUND
Premenstrual syndrome (PMS) is used to describe physical, cognitive, affective, and behavioral symptoms that affect young and middle-aged women occurring cyclically during the luteal phase of the menstrual cycle. Despite the considerable prevalence and impact of PMS on individuals, their families and communities that interferes with the development of nations, many professionals are still unaware of it and little attention has been given in developing countries like Ethiopia, especially for university students. Therefore, this study was aimed for assessing the magnitude of premenstrual syndrome, associated factors and coping mechanisms among Wolkite university female regular students, 2021.
METHODS
Institutional-based cross sectional study was conducted among Wolkite University regular female students from June 15/10/2021 to 30/10/2021 by using simple random and multistage with systematic random sampling technique to select the study participants (n = 591). Data were collected using a self-administered, pre-tested, semi-structured questionnaire. Premenstrual syndrome scales comprised of 40 questions with three sub-scales were used to determine Premenstrual syndrome. Data were cleaned, coded and entered into Epi-data version-3.1, and analyzed using SPSS software version 25. Descriptive statistics were computed for independent variables as well as for coping mechanisms and presented in narration, tables and graphs. Analytic analysis schemes including bi-variable and multivariable logistic regression were computed to identify factors associated with premenstrual syndrome and those variables with a P value of < 0.05 in multivariable analysis were declared as statistically significant.
RESULT
From the total of 631 study subjects, only 591 had completed the questionnaire, giving a response rate of 93.7%. From 591 study participants, 224 (37.9%) [95% CI: (34, 40.9)] of them had premenstrual syndrome. Abdominal cramp (78.8%), depression (73.3%) and fatigue (72.9%) were frequent premenstrual symptoms experienced by students. Having family history of PMS [AOR: 4.05; 95% CI: (2.49, 6.58)], no history of sexual intercourse [AOR: 2; 95% CI: (1.12, 3.47)], severe menstrual pain intensity [AOR: 3.09; 95% CI: (1.58, 6.05)], irregular menstrual cycle [AOR: 2.26; 95% CI: (1.41, 3.62)], early age of menarche (< 13 years) [AOR: 2.64; 95% CI: (1.34, 5.19)], long duration of menses (≥ 7 days) [AOR: 3.56; 95% CI: (1.53, 8.37)] and using many pads (> 8) during menstruation [AOR: 4.44; 95% CI: (2.16, 9.12)] were factors significantly associated with premenstrual syndrome. 93.4% of students apply at least one coping mechanism for premenstrual symptoms, of which; taking rest (67.6%) and sleeping (60.7%) were common strategies.
CONCLUSION
In this study, premenstrual syndrome was found to be a problem of many students. Abdominal cramp, depressed feeling and fatigue were the predominant premenstrual symptoms experienced by students. Taking rest and sleeping were mostly applied by students as a coping mechanism. Family history of PMS, no history of sexual intercourse, intense menstrual pain, use of many pads during menstruation, irregular menstrual cycle, early menarche, and long duration of menses were found to be predictors of premenstrual syndrome. PMS needs great attention as part of the health care service in Ethiopia by involving all stockholders, including policy makers and health care professionals, to reduce its impact on the academic performance of university students.
Topics: Adaptation, Psychological; Adolescent; Colic; Cross-Sectional Studies; Dysmenorrhea; Ethiopia; Fatigue; Female; Humans; Menstruation Disturbances; Middle Aged; Premenstrual Syndrome; Students; Surveys and Questionnaires; Universities
PubMed: 35321710
DOI: 10.1186/s12905-022-01658-5