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Pregnancy Related clinical trials

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NCT ID: NCT05621109 Recruiting - Clinical trials for Overweight and Obesity

PRE-Pregnancy Weight Loss And the Reducing Effect on CHILDhood Overweight - Copenhagen

PREPARE CHILD
Start date: December 15, 2022
Phase: N/A
Study type: Interventional

The study is a single site parallel randomized controlled study. The study will be assessing the effect of approximately 10% weight loss intervention vs a control group among healthy females/couples where the prospective mother is overweight or obese (BMI 27-45 kg/m^2) and between 18-38 years. The investigators will recruit a total of 240 healthy females/couples who will be randomized 1:1 to either intervention or control, stratified according to maternal pre-pregnancy BMI. The overall objective is to test whether a comprehensive pre-conceptional parental weight loss intervention effectively reduces the risk of offspring overweight and adiposity and its complications compared to a control group. The investigators hypothesize that parental weight loss intervention, initiated before conception, will facilitate lower parental insulin resistance, inflammation, body weight and adiposity, incretin responses compared to usual care. For the offspring the investigators hypothesize that the intervention will reduce adverse pregnancy outcomes with a reduction in offspring neonatal adiposity, reduced risk of being born large for gestational age (LGA) and with lower BMI z-score at 18 months.

NCT ID: NCT05609669 Active, not recruiting - Pregnancy Related Clinical Trials

Continuous And Data-drivEN CarE (CADENCE) Pilot

CADENCE
Start date: August 23, 2023
Phase: N/A
Study type: Interventional

The proposed project seeks to use public health and clinical data on opioid use disorders (OUD) outcomes for mother and infants, which is the leading cause of death to mothers one year after deliver and can lead to neonatal withdrawal syndrome (NOWS) and other poor outcomes. Insufficient or incomplete data about OUD and lack of integrated programs for OUD treatment during pregnancy can be barriers to providing optimal care to mothers and infants.

NCT ID: NCT05605340 Recruiting - Pregnancy Related Clinical Trials

Healthier At-home Meals for Expectant Mothers

Her HOME
Start date: August 9, 2023
Phase: N/A
Study type: Interventional

This study is being done to test the feasibility, acceptability, and preliminary efficacy of a meal delivery intervention for managing gestational weight gain among pregnant women with overweight or obesity.

NCT ID: NCT05597943 Recruiting - Pregnancy Related Clinical Trials

mHealth Smartphone App and Postpartum Glucose Intolerance for Patients With GDM

Start date: May 1, 2023
Phase: N/A
Study type: Interventional

Without intervention, approximately 70% of women diagnosed with GDM will develop type 2 diabetes mellitus in their lifetime. Abnormal results of a 2 hour oral glucose tolerance test (OGTT) performed as early as 2 days postpartum are predictive of impaired glucose tolerance 1 year postpartum. The investigators hypothesize that use of the Malama smartphone application to optimize antenatal glycemic control will result in lower incidence of postpartum glucose intolerance, which may decrease long term risk of progression to diabetes mellitus.

NCT ID: NCT05588245 Recruiting - Pregnancy Related Clinical Trials

Trial of Community-based Patient Navigation

Start date: January 25, 2024
Phase: N/A
Study type: Interventional

This study will test the effectiveness of a community-based patient navigator intervention from mid-pregnancy through 12 month postpartum for a high-risk population of medically underserved women. The RCT will enroll 540 pregnant women before 20 weeks of pregnancy and randomly allocate them into two different study arms from the time of prenatal enrollment through 12 months postpartum. If found to be effective, the community-based patient navigator intervention can be implemented as a standard of care at Grady and other provider practices serving high-risk women to improve maternal health outcomes and reduce racial disparities.

NCT ID: NCT05578690 Recruiting - Clinical trials for Overweight and Obesity

Healthy Lifestyle Before and During Pregnancy to Prevent Childhood Obesity - the PRE-STORK-trial

Start date: October 26, 2022
Phase: N/A
Study type: Interventional

Introduction: The prevalence of childhood overweight and obesity has risen from just 4% in 1975 to more than 18% in 2016. Little is known about adiposity of the infant, but it positively associates to the mother's BMI. Globally, the prevalence of overweight has tripled since 1975 and is now affecting one of three Danish women at the time of pregnancy. However, despite increasing awareness of obesity and accumulating evidence of its health consequences limited effect of intervention in childhood obesity exists. Maternal obesity before conception, an excessive increase in body weight during pregnancy and physical inactivity are some of the risk factors suspected of infant adiposity. Lifestyle interventions during pregnancy have shown limited or no effect in the offspring. Therefore, renewed effort to improve the prevention of childhood obesity is warranted. Methods and analysis: This is a randomized, parallel group, tailored, multifactorial lifestyle intervention trial in women (age 18 to 38 years) with overweight or obesity (BMI 27 to 42 kg/m2) seeking pregnancy. The women are randomized 1:1 to either the lifestyle or standard of care group. The lifestyle intervention is initiated prior to pregnancy. The lifestyle intervention is set off with a low-calorie diet for 8 weeks and throughout the intervention period (prior to and during pregnancy) participants follow an intervention containing exercise according to the World Health Organization guidelines, healthy diet and mentorship to maintain healthy weight before and during pregnancy.The primary outcome is the difference in neonatal adiposity measured at birth. Finally, a child and family cohort will be established to follow the children throughout childhood for healthy weight development. The study will provide evidence of effects from pre-conception-initiated intervention and have the potential to improve health and quality of life for children. Ethics and dissemination: The trial has been approved by the ethical committee of the Capital Region of Denmark (H-22011403) The trial will be conducted in agreement with the Declaration of Helsinki and monitored to follow the guidelines for good clinical practice. Results will be submitted for publication in international peer-reviewed scientific journals.

NCT ID: NCT05576363 Not yet recruiting - Pregnancy Related Clinical Trials

Food Security and Maternal Nutrition Status

Start date: July 28, 2023
Phase:
Study type: Observational

Food insecurity has been climbing slowly for several recent years and affects more than 30% of the world population in 2021. Poor households tend to have poor diet quality in accordance to expensive price of food, thus reduce dietary diversity. They frequently consume low-cost foods that are high in energy density but low in micronutrient content, diets that are poor in fruits, vegetables, milk, and dairy products, and eating habits that are unhealthy. The double burden malnutrition will affect pregnant women who were vulnerable due to increase demand of nutrition during pregnancy and also their infants. Food insecurity has been linked to maternal stress, weight gain, gestational diabetes, low birth weight, birth defects, premature birth, hospitalization of infants aged less than 6 months and cause the long-term consequences for child growth and development. Therefore, this study aimed to examine the level of food security and its association with maternal nutrition and birth outcomes. This prospective cohort study will be conducted among 150 pregnant women (in 2nd trimester) at government health clinic near Kota Kinabalu. The participants will be assessed on sociodemographic data, socio-economic, medical history, anthropometry measurements, food security, dietary intake and stress level at baseline. After 6 months, birth outcomes will be recorded. The expected outcomes will be that there will be high prevalence of food insecurity among pregnant mother. Besides, the food insecure mothers will be associated with poor nutritional status and have negative consequences on birth outcomes (low birth weight and short stature). This study will highlight the level of food insecurity to inform much needed interventions to address important global health challenges of nutrition and could improve the prenatal care.

NCT ID: NCT05570630 Enrolling by invitation - COVID-19 Clinical Trials

VAX-MOM COVID-19: Increasing Maternal COVID-19 Vaccination

Start date: October 21, 2022
Phase: N/A
Study type: Interventional

COVID-19 infection during pregnancy is associated with increased risk of pre-eclampsia, preterm birth and stillbirth. Pregnant people with COVID-19 have a higher rate of ICU admission and intubation than those who are not pregnant. COVID-19 vaccine is recommended before pregnancy and during pregnancy to decrease these risks. Despite the benefits of COVID-19 vaccination, only 71% of pregnant women were vaccinated for COVID-19 as of June 2022 (most prior to pregnancy), with a much lower rate of 58% among non-Hispanic Black women. An effective intervention is needed to improve COVID vaccination rates for pregnant people overall. In this study, the investigators will perform a randomized controlled trial aimed at practice change in obstetricians' offices, with an overall goal of increasing maternal COVID-19 vaccination rates.

NCT ID: NCT05570396 Recruiting - Metabolic Syndrome Clinical Trials

Long-term Follow-up on Childhood Adiposity - The FitKids Study

Start date: October 10, 2022
Phase:
Study type: Observational

The FitKids study is a mother-child observational cohort study on obesity and metabolism in children three years of age. The study will follow up on the FitMum and FitBaby studies, conducted from 2018-2022. The children in FitKids are born by mothers who completed the FitMum study, a single-site three-armed RCT, targeting physical activity during pregnancy. 220 pregnant women were randomly assigned to one of three arms during pregnancy: structured supervised exercise training, motivational counselling supported by health technology, or a control group receiving standard treatment. From inclusion and until one-year post-partum, the women wore an activity tracker 24/7 providing important information about adherence to the prescribed intervention. The primary objective of the FitKids study is to investigate the effect of lifestyle interventions during pregnancy on body composition (fat percentage measured by dual energy x-ray absorptiometry) and risk of childhood obesity in off-springs. The secondary objectives are to investigate the effect of lifestyle interventions during pregnancy on obesity-associated dys-metabolic traits and mental health in off-springs as well as to gain insight into presumed causal factors for overweight and obesity in children. The investigators hypothesize that children of mothers, who during their participation in FitMum, received an intervention will have a healthier body composition expressed as a fat percentage within the normal range for a 3-year-old child compared to children of mothers in the control group.

NCT ID: NCT05562726 Recruiting - Pregnancy Related Clinical Trials

Pregnancy in Greek Female Patients With Inflammatory Bowel Disease - Panhellenic Recording

Start date: January 1, 2020
Phase:
Study type: Observational [Patient Registry]

The aim of the present study is to retrospectively record all the successful pregnancies in Greek IBD patients within the last 10 years and prospectively record all the future pregnancies for the next 4 years. Data will be obtained regarding IBD clinical parameters, before, during and after the pregnancy, pregnancy outcomes, delivery mode, lactation and health status of the offspring. Moreover, the management of the pregnant IBD patients in Greece will be analyzed and compared to the European guidelines, in an effort to develop a position statement applicable to the Greek NHS.