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Pregnancy clinical trials

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NCT ID: NCT03375359 Recruiting - Pregnancy Clinical Trials

First Trimester Screening for Trisomy 21, 18, 13 and 22q11.2 Deletion Syndrome

ReFaPo02
Start date: January 8, 2018
Phase:
Study type: Observational

Combined first-trimester screening represents the gold standard of risk assessment for the presence of trisomy 21, 18, and 13. The concept is based on the age risk, the measurement of fetal nuchal translucency (NT), and the determination of serum markers free beta-hCG and PAPP-A in maternal blood. In recent years it has been shown that the risk assessment can be improved by combining in-depth ultrasound and cell-free DNA analysis from maternal blood. In their latest study, the investigators were able to detect all fetuses with trisomy 21, 18, and 13 through this procedure. No normal fetus displayed an increased risk. In contrast, the detection rate in classic, combined first-trimester screening is about 95% and the false-positive rate is 3-5%. In this study the investigator examine the test quality - especially the false positives - of cell-free DNA analysis on trisomy 21, 18 and 13 as well as on the microdeletion 22q in 1000 pregnancies.

NCT ID: NCT03215784 Recruiting - Obesity Clinical Trials

Gestational Obesity and Interventions With Probiotics or Fish Oil Trial

GOPROFIT
Start date: March 2015
Phase: N/A
Study type: Interventional

Obesity is one of the most concerning health issues in the modern world, especially due to its association with greater risk of developing a wide range of chronic diseases. Pre-gestational obesity may increase the chances of maternal and fetal morbimortality, such as gestational diabetes mellitus, preeclampsia, macrosomia and, even, fetal death. It may also lead to long term disorders, enhancing the risk of excessive adiposity and metabolic syndrome in later life and, thus, contributing to the maintenance of the obesity cycle and its health effects through the subsequent generations. Alterations in placental function are thought to be deeply involved in this scenario, however further research on its molecular and biological mechanisms is needed. During pregnancy, there is a physiological enhancement of the inflammatory state, marked by higher circulating cytokines and macrophage placental infiltration, which favors fetal nutrient supply and adequate growth; however, this response is exacerbated in women with pre-pregnancy obesity, leading to adverse outcomes. In this context, interventions aiming to reduce excessive inflammation may prevent or minimize the negative impact of pre-pregnancy obesity on both maternal and offspring's health. There is strong evidence suggesting an important role of n-3 LC-PUFA (EPA and DHA) on the attenuation and resolution of inflammatory states, besides influencing maternal lipid profile, fetal and infant adipogenesis and neurodevelopment. Additionally, the consumption of probiotic supplements during gestation seams to promote adequate maternal weight gain and improve the profile of inflammatory molecules secreted in the milk. Therefore, the nutritional interventions with fish oil, as a source of EPA and DHA, or probiotics, in women with pre-pregnancy obesity, may change the intrauterine environment and reduce the risk of both short and long term metabolic disorders. This study aims to investigate the metabolic and molecular changes promoted by gestational obesity and evaluate the effectiveness of different dietary interventions (fish oil or probiotic) on preventing or minimizing such alterations. We expect to contribute to the understanding of the physiological and molecular mechanisms underlying maternal obesity and its association with adverse pregnancy outcomes, associated with increased risk of chronic diseases in adulthood.

NCT ID: NCT03194659 Recruiting - Pregnancy Clinical Trials

Synergy Between Choline and DHA

Start date: October 5, 2017
Phase: N/A
Study type: Interventional

The purpose of this study is to determine whether choline supplementation influences the availability of docosahexaenoic acid throughout pregnancy.

NCT ID: NCT03134274 Recruiting - Pregnancy Clinical Trials

Study Assessing the Usability and Patient Satisfaction With Digital Urinalysis in the Context of Routine Pre-natal Care.

Start date: May 7, 2017
Phase: N/A
Study type: Interventional

The study is a home-based, usability study assessing the use of the Dip Home-Based Dipstick Analyzer (HBDA) in the context of prenatal care.

NCT ID: NCT02989142 Recruiting - Obesity Clinical Trials

Inter-pregnAncy Coaching for a Healthy fuTure

inter-act
Start date: April 1, 2017
Phase: N/A
Study type: Interventional

The project focuses on prevention of major pregnancy and birth related complications : pregnancy-induced hypertension (PIH), gestational diabetes mellitus (GDM), caesarean section (CS), and large-for-gestational-age (LGA), i.e. the birth weight of the baby exceeds the 90% percentile of birth weights for the specific pregnancy duration. The investigators focus on the pre-conception period, i.e. the pre-conception period of the 2nd pregnancy in women with an excessive weight gain during their 1st pregnancy, aiming to decrease the complications rate in their 2nd pregnancy. Women with an excessive gestational weight gain have obtained the extra weight during a rather short period of time, e.g. 20 kilos in the last 4 or 5 months of their pregnancy. This characteristic distinguishes the target group from the general population with overweight/obesity, in whom the extra weight was acquired during many years and independent from a pregnancy, making a behaviour change more complex. The coaching intervention combines face-to-face counselling with the use of a mobile App connected to medical devices (scale and pedometer). The app monitors important indicators (weight, eating behaviour, physical activity, mental wellbeing), provides coaching through established behavioral change techniques, and is specifically tailored for women with excessive weight gain during the previous pregnancy. The goal is to decrease the rate of pregnancy and birth-related adverse outcomes in the next pregnancy by a healthy life style, starting shortly after their 1st delivery and sustained during the next pregnancy.

NCT ID: NCT02989025 Recruiting - Pregnancy Clinical Trials

Progesterone to Enhance the Efficacy and Success of Expectantly Managed Preterm Severe/Superimposed Preeclampsia

PROGRESS
Start date: May 22, 2017
Phase: Phase 2
Study type: Interventional

The purpose of this study is to learn if giving 17-hydroxyprogesterone caproate (17 OHPC) to mothers with preeclampsia diagnosed before 34 weeks gestation improves mother and baby outcomes.

NCT ID: NCT02962466 Recruiting - Pregnancy Clinical Trials

Multicenter Prospective Cumulus Cell Test Study

MC_CC-Test
Start date: November 2016
Phase: N/A
Study type: Interventional

Performing an additional non invasive oocyte diagnostic test based on cumulus gene expression could improve the outcome of the ART cycle.

NCT ID: NCT02948439 Recruiting - Pregnancy Clinical Trials

Prenatal Exercise and Cardiovascular Health (PEACH)

PEACH
Start date: July 2016
Phase: N/A
Study type: Interventional

Maintenance of a healthy pregnancy depends on an appropriate adaptation and responsiveness of blood vessels, to ensure appropriate blood flow to the fetus during everyday stressors. Previous work by the investigators has demonstrated that during pregnancy, the part of the nervous system responsible for cardiovascular function (the sympathetic nervous system) is hyperactive. The investigators also know that in women who develop high blood pressure during pregnancy that sympathetic nervous system activity is even higher. Yet, very little is known about why this occurs and how this might be affected. Pregnant women are encouraged to be active, yet, less than 15% of women perform sufficient exercise to meet current guidelines. This is important because hyperactivity of the sympathetic nervous system is observed in other inactive populations and has been linked to adverse cardiovascular health outcomes including hypertension, atherosclerosis, heart attack, and stroke. Indeed, in 2011, the American Heart Association stated that inactivity was a risk factor as potent as cigarette smoking for the development of future cardiovascular disease in women. The investigators' work and others have demonstrated that exercise during pregnancy is beneficial for both the mom and baby; however, the effect of prenatal exercise on neurovascular function is not known. If exercise is effective in controlling the increase in sympathetic activity that occurs during pregnancy, or its effects on the cardiovascular system, this may help prevent the development of high blood pressure or other cardiovascular problems during pregnancy.

NCT ID: NCT02924636 Recruiting - Obesity Clinical Trials

Electronic-personalized Program for Obesity in Pregnancy to Improve Delivery

ePPOP-ID
Start date: November 13, 2017
Phase: N/A
Study type: Interventional

The purpose of this study is to assess the efficacy of an electronic-based intervention to help pregnant overweight and obese women gain an appropriate amount of weight and improve their delivery i.e. to reduce the rate of labour procedures and interventions. We chose a composite outcome including instrumental delivery and Caesarean section, as clinically relevant outcomes because the mode of delivery is one of the major goals of the obstetrical management and is is strongly associated with body mass index and gestational weight gain.

NCT ID: NCT02895165 Recruiting - Pregnancy Clinical Trials

PREgnancy and FERtility Registry

PREFER
Start date: November 2012
Phase:
Study type: Observational [Patient Registry]

The PREgnancy and FERtility (PREFER) study is a comprehensive program aiming to optimize care and improve knowledge around the topics of fertility preservation and pregnancy issues in young breast cancer patients. The program was initiated at the National Institute for Cancer Research, IRCCS AOU San Martino - IST in Genova (Liguria Region, Italy) and then it has been spread to other Italian Institutions under the umbrella of the Gruppo Italiano Mammella (GIM) study group. It is composed of two distinctive studies, one assessing fertility (i.e. PREFER-FERTILITY) and the other pregnancy (PREFER-PREGNANCY) issues. Hence, two different study protocols were developed under the umbrella of the PREFER registry. PREFER-FERTILITY aims to obtain and centralize data about the preferences and choices of young cancer patients on the fertility preservation strategies available in Italy. Furthermore, it aims to assess the outcomes of patients undergoing one or more strategies for fertility preservation in terms of success of the techniques (i.e. recovery of ovarian function, number of cryopreserved oocytes, post-treatment pregnancies) and safety (i.e. long-term survival outcomes). PREFER-PREGNANCY has two main objectives: 1) to obtain and centralize data on the management of breast cancer diagnosed during pregnancy, the obstetrical and paediatric care of children born after prior in utero exposure to anticancer treatments, and the long-term survival outcomes of these patients; 2) to obtain and centralize data on the clinical outcomes of breast cancer survivors that achieve a pregnancy after prior diagnosis and treatment of breast cancer.