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Amenorrhea clinical trials

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NCT ID: NCT03841981 Recruiting - Clinical trials for Polycystic Ovary Syndrome

Body Fat as Determinant of Female Gonadal Dysfunction

Start date: January 31, 2020
Phase:
Study type: Observational

Reproduction requires from women enough energy depots to warrant an adequate nutritional supply to the fetus. Hence, adipose tissue is able to communicate with female hypothalamic-pituitary-ovary axis. The hypothesis of the project is that abnormalities in the quantity (absolute and relative to lean body mass), distribution and/or function of adipose tissue are associated with functional forms of female gonadal dysfunction in predisposed women, in a spectrum of anomalies that go from hypothalamic amenorrhea to the polycystic ovary syndrome (PCOS). To challenge this hypothesis, the investigators will study 5 groups of 10 women each: women with exercise-associated hypothalamic amenorrhea, women without ovulatory dysfunction that exercise equally, non-hyperandrogenic patients with PCOS, hyperandrogenic patients with PCOS, and healthy control women comparable to those with PCOS. The aims of the study will be: Primary objective: To identify novel signalling factors originating from adipose tissue and muscle using targeted and nontargeted evaluation of the proteome and of gene expression of superficial subcutaneous fat, deep subcutaneous fat (which mimics visceral adipose tissue) and skeletal muscle. Secondary objectives: 1. To study the serum adipokine profile - including those identified by the primary objective - and circulating gut hormones during fasting and after a glucose load in the 5 groups of women, and their associations with sexual hormones and body fat distribution. 2. To study body composition and body fat distribution in these women and their relationships with: 2.1, Sex steroid profiles. 2.2. Classic cardiovascular risk factors: carbohydrate metabolism, lipid profiles and blood pressure. 2.3 Markers of low-grade chronic inflammation. 2.4. Oxidative stress markers. 2.5. Cardiovascular autonomic function. 2.6. Surrogate markers of subclinical atherosclerosis. 2.7. Circulating concentrations of endocrine disruptors. 2.8. Oral and gut microbiome. The results will provide a better understanding of the mechanisms linking body energy depots with the female reproductive axis and, hopefully, the identification of potential biomarkers for the diagnosis and treatment of the disorders studied here.

NCT ID: NCT03794895 Completed - Clinical trials for Women's Health: Amenorrhea/Dysmenorrhea

Prediction of Response to IUCD Associated Menorrhagia Using Doppler

Start date: May 1, 2017
Phase: N/A
Study type: Interventional

Studying the efficacy of uterine artery doppler in predicting response to mefenamic acid in women having IUCD associated menorrhagia

NCT ID: NCT03732261 Terminated - Bone Loss Clinical Trials

Effects of Exercise and Yogurt on Bone Mineral Density and Immunological Factors in Human Milk: The MEEMA Study

MEEMA
Start date: April 1, 2019
Phase: N/A
Study type: Interventional

Obesity in America has risen to epidemic levels over the past 20 years. For women, childbearing itself could be a contributing factor to this high prevalence of excess weight. In addition, for women who breastfeed, lactation is a time of rapid bone loss due to hyperprolactinemia, amenorrhea, and increased bone turnover, especially in the lumbar spine and hip. The American Academy of Pediatrics recommends exclusive breastfeeding for the first 6 months, continue to at least 12 months with the introduction of complementary foods and up to 2 years. Breastfeeding helps reduce long term maternal weight retention from pregnancy, the risk of childhood obesity and provides a number of immunological factors to promote the immune system and gastrointestinal system of the neonate. Bone loss due to lactation is usually reversed with weaning; however, not all women recover from this bone loss which increases the risk of osteoporosis later in life. Weight bearing exercise and dairy intake (milk, yogurt, cheese) plus vitamin D supplementation may provide some protection from bone loss. Thus, the objective of this study is to promote long-term lifestyle changes that support healthy lifelong weight management through a community based exercise intervention and daily yogurt consumption program aimed at overweight- to- obese lactating postpartum women.

NCT ID: NCT03669731 Recruiting - Clinical trials for Pregnant Women From 20 Amenorrhea Weeks

Evaluation of the Protein Intake of the Pregnant Woman According to the Weight Status and in Pregnant Women Operated on Bariatric Surgery

BariaProG
Start date: October 10, 2018
Phase: N/A
Study type: Interventional

Adequate equipment for lifelong health is essential to ensure healthy health for fetal development. In France, pregnant women with normal weight have increased protein intake to 0.78-0.95g / kg / day (ANC 2001). And more recently, AFSSA from 2007 proposed a recommended nutritional intake of 0.82-1g / kg / d. An increased requirements in the second and third trimester of 0.25 g / kg / day and 0.46 g / kg / day, respectively, compared with non-pregnancy values. However, the prevalence of the incompatibility remains unknown. In addition, maternal protein intake is inadequate or excessively associated with both intra-uterine growth retardation and small gestational age weights. Neonatal hypotrophy is also associated with a risk of chronic diseases in adulthood, including cardiovascular disease, type 2 diabetes, insulin resistance, high blood pressure and coronary heart disease. In obese women or patients undergoing surgery for bariatric surgery, there is currently no recommendation on the recommended protein intake. Or, maternal obesity plays a role in the metabolic development of children and bariatric surgery is associated with a major risk of maternal micronutrient deficiencies and intra-uterine growth retardation. Prevalence of obesity in France is currently estimated at 17%. Moreover, bariatric surgery is also fast-growing in France with a number of interventions having tripled since 2006. Thus, a better understanding of maternal food needs and applications throughout pregnancy is needed to improve dietary guidelines and promote fetal, neonatal and long-term health.

NCT ID: NCT03651115 Recruiting - Clinical trials for Gentamicin and/or Vancomycin

TDM of Gentamicin and Vancomycin, in Neonates, Using Dried Blood Spot Sampling.

MIDOMEN
Start date: December 15, 2017
Phase:
Study type: Observational

Gentamicin and vancomycin, widely used in neonatology, are antibiotics with a narrow therapeutic index and a risk of nephrotoxicity and ototoxicity. For these drugs, therapeutic drug monitoring (TDM) is required, to optimize the efficacy and tolerance of these antibiotics. In newborns, the TDM of these antibiotics is really available, because of physiological features, such as renal elimination and hepatic metabolism which are both very dependent on age and maturation. Thus, in newborn, there is a large interindividual variability of pharmacokinetic parameters, making the dosage adjustment of antibiotics very difficult. Unfortunately, because of a limited blood mass, the TDM of these antibiotics is very rarely practiced in these children. The introduction of a Died blood spot (DBS), which uses only a single drop of blood (<50 μL) preserved in dried form, thus makes it possible to reduce the blood volume taken and avoid the venous intrusion. The dosage needs the use of liquid chromatography coupled with tandem mass spectrometry (LC-MSMS), the only sensitive technique to work with such a low blood volume. We therefore wish to develop this approach coupling DBS and LC-MSMS, in neonatology, to evaluate the concentration of these nephrotoxic antibiotics (gentamicin and vancomycin), as TDM. The blood concentrations of the antibiotic, per 100 new-born term or premature (50 gentamicin, 50 vancomycin), are compared to the physiological state of the child (premature or not, intrauterine growth retardation or not), its hemodynamic status (shock or not) and its efficacy / toxicity, evaluated by the clinician using a questionnaire. The use of this new sampling method, as an alternative to conventional blood sampling, makes it possible to better monitor the concentrations of gentamicin and vancomycin in neonatalogy, thus reducing the risk of toxicity of these antibiotics.

NCT ID: NCT03568851 Completed - Breast Feeding Clinical Trials

Reproductive Health Outcomes by Method of Breast Milk Feeding

Start date: June 27, 2018
Phase:
Study type: Observational

The purpose of this research is to determine whether there are differences in ovarian suppression between women who are feeding at the breast compared with women who are pumping. - In the main study, the aim is to compare reproductive health outcomes, including amenorrhea rates, duration of lactation, and resumption of sexual activity, between mothers who are exclusively breastfeeding (i.e. feeding at the breast) and those who are pumping after a term or preterm delivery. - In the sub-study, the aim is to determine the feasibility and acceptability of using urinary luteinizing hormone (LH) detection kits at home to detect ovulation in exclusively breastmilk feeding women.

NCT ID: NCT03403894 Completed - Clinical trials for Infant, Extremely Premature

Description of Practices Implemented in the Birth of Living Children Before 24 Weeks of Amenorrhea

Start date: November 10, 2018
Phase:
Study type: Observational

Every year, at the Nice University Hospital, about sixty deliveries take place before 24 weeks of amenorrhea. The child is not viable because of his extreme immaturity. In most cases, a child born before 24 years of age is stillborn, but in about one in three cases, it shows signs of life such as heartbeat, breathing, gasps or limb movements. With these too small children showing signs of life, three attitudes are possible: doing nothing and waiting for this life to stop by themselves, setting up palliative care to ensure the child's comfort, or administering a medication to shorten his or her life. The attitude to have is not univocal and the feeling of the teams confronted with their management is difficult even if the goal of the caregivers is always to act as best as possible. The main objective of the study is to describe the clinical state of the child and the practices implemented in the birth room at the Nice University Hospital when children showing signs of life before 24 weeks of amenorrhea are born. The secondary objective is to describe caregivers' experiences, their experiences of these situations and attitudes towards children and their parents, and to identify ethical dilemmas in these situations. This study is an observational cohort study including all births of live children before 24 weeks of amenorrhea at Nice University Hospital for 12 months. It consists of two parts: a quantitative study describing the child's condition and caregiving practices, and a qualitative study of caregivers' experiences and the determinants of their attitudes towards the child. The investigator will coordinate the collection of the data necessary to conduct the quantitative study, and then conduct individual semi-directive interviews with each of the caregivers present at the birth of the child. The qualitative study will be based on the analysis of these interviews.

NCT ID: NCT03140384 Withdrawn - Misoprostol Clinical Trials

Compare the Different Routes of Administration of Misoprostol During Medicinal Abortion Between 7 and 9 Weeks of Amenorrhoea (SA)

Misoprostol
Start date: August 20, 2017
Phase: Phase 3
Study type: Interventional

In France, drug-induced abortion is allowed up to 9SA, after which the surgical route is preferred. Mifepristone 600mg is used 36-48 hours before the introduction of Misoprostol. This is recommended orally at a dose of 400 μg. There are currently several studies on the subject, including a meta-analysis of the 2011 Cochrane Database, but doses, routes of administration and gestational age differ in all studies. Currently, HAS recommends the vaginal route at the dose of 800μg for stopped pregnancies. It is therefore necessary to compare the different routes of administration of Misoprostol at the same dose to allow to change our French recommendations on the medicinal abortion and perhaps also to recommend the vaginal route in this indication.

NCT ID: NCT03018366 Completed - Clinical trials for Cardiovascular Disease (CVD)

Atherosclerosis, Immune Mediated Inflammation and Hypoestrogenemia in Young Women

Start date: January 1, 2017
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine whether low estrogen levels in young women with hypothalamic amenorrhea (premenopausal HypoE) is associated with risk factors for cardiovascular disease. For this study, the investigators will measuring vascular function and immune markers on: - young women with hypothalamic amenorrhea (>3 months of no menstrual cycle due to low estrogen) - young women with regular menstrual cycles not on hormone therapy. - recently menopausal women (<3 years from final menstrual period) not on hormone therapy. Premenopausal HypoE participants will then be randomized to use either an estrogen patch or a placebo patch (no active medicine) for 3 months, followed by estrogen or placebo patch plus progesterone or placebo pills for 2 additional weeks. The investigators are looking to see if estrogen improves vascular and immune function.

NCT ID: NCT03007459 Completed - Depression Clinical Trials

The Health of Competitive Fitness Athletes

Start date: November 2016
Phase:
Study type: Observational

Fitness athletes emphasize the value of staying lean, muscular and defined, and motivates and inspires followers through social media. We want to study the effect of such lifestyle on selected aspects of psychological and physical health in female fitness athletes, and compare the outcomes to a healthy, physically active female population.