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Pregnancy Related clinical trials

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NCT ID: NCT04962477 Active, not recruiting - Pregnancy Related Clinical Trials

Understanding Host-pathogen Interaction in the Respiratory Mucosa During Pregnancy

Start date: March 2, 2022
Phase:
Study type: Observational

The clinical presentation of the ongoing coronavirus disease-19 (COVID-19) pandemic in pregnant women is unique with more asymptomatic infection, higher morbidity when symptomatic, yet without a difference in mortality rate. This is strikingly different from the high mortality observed during the past influenza A pandemics. Though both influenza A virus (IAV) and SARS-CoV-2 are single-stranded RNA viruses, the exquisite vulnerability of pregnant women to influenza A but not COVID-19 remains a mystery. Our objective, therefore, is to determine the mechanisms that predispose pregnant women to severe influenza A but confer protection against SARS-CoV-2 infection by examining the viral entry factors and innate immune response mechanisms in the nasal epithelium of pregnant vs. non-pregnant age-matched women.

NCT ID: NCT04830241 Active, not recruiting - Pregnancy Related Clinical Trials

Neonatal Hypotonia Associated With in Utero Exposure to Antidepressant

Start date: March 25, 2021
Phase:
Study type: Observational

To better characterize the neonatal hypotonia associated with in utero exposure to antidepressants, so far limited to clinical cases, we will perform an observational retrospective pharmacovigilance study, using two databases. First, disproportionality analysis in Vigibase®, the World Health Organization global database, will be perform between antidepressant drugs and neonatal hypotonia . Second, narratives from the French National Pharmacovigilance Database will be extracted.

NCT ID: NCT04828070 Active, not recruiting - Pregnancy Related Clinical Trials

The Heart Outcomes in Pregnancy Expectations (H.O.P.E) Registry

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

Prospective US registry of pregnant women with cardiac disease to address the substantial gaps in knowledge surrounding these patients, in order to improve future care.

NCT ID: NCT04749888 Active, not recruiting - Pregnancy Related Clinical Trials

Impact of the Korea Early Childhood Home-visiting Intervention

KECHI
Start date: October 27, 2021
Phase: N/A
Study type: Interventional

Maternal and early childhood home visits have been proposed as an effective strategy to improve the health and development of disadvantaged children. In South Korea (hereafter, Korea), a maternal and early childhood home visit program has been implemented since 2013 in Seoul, and then was adopted in 2019 by the central government as a national policy for child health and development. The Korea Early Childhood Home-visiting Intervention (KECHI) encompasses 25-29 home visits, group activities, and community service linkage by social workers from the prenatal period until the child reaches the age of 2 years; as such, it is a complex intervention involving various domains to address a wide range of outcomes. Each home visit is implemented based on the family's needs, and individualized interventions are provided to improve parenting and the home environment in order to promote children's health and development and maternal health. This study is a randomized controlled community trial conducted in Korea to examine the impact of targeted home visits led by nurses in the prenatal and early childhood period on children's health and development and maternal health. This study is a superiority trial with two parallel groups from pregnancy until the child reaches 2 years of age. Pregnant women with two or more risk factors will be recruited to participate in the study after they provide informed consent. Participants will then be randomly assigned to the intervention or control group with a 1:1 allocation through an independent web-based random allocation system. We expect a total of 800 families (400 families in each group) to be recruited. The intervention group will receive the KECHI program and the control group will receive existing maternal and child health services (usual care), but not multiple home visits by nurses. Both groups will receive gift cards of 30,000 Korean won (about 27 USD) for each round of surveys. The intervention and control groups will be surveyed on the outcome variables of home environment, child development, breastfeeding, maternal health, child hospital visits due to injuries, and community service linkage at four home visits by trained research nurses at baseline and at 6 months, 12 months, and 24 months after birth. Telephone contact will also be made at 6 weeks and 18 months after birth for both groups. Outcome measurements will be performed by research nurses and data management will be conducted by statistical analysts. The analysis will be conducted for the intention-to-treat (ITT) and per-protocol (PP) groups, with an interim analysis of outcomes up to the 6-month follow-up. For the primary outcomes and certain secondary outcomes, subgroup analyses will be performed based on factors such as region, fertility status, number of risk factors, presence of depression, education level, etc.

NCT ID: NCT04718220 Active, not recruiting - Covid19 Clinical Trials

Safety, Testing/Transmission, and Outcomes in Pregnancies With COVID-19

STOPCOVID19
Start date: March 1, 2021
Phase: N/A
Study type: Interventional

Pregnant women are a vulnerable and high-risk population, as COVID-19 is associated with an increased risk preterm birth, cesarean section, and maternal critical care. This study will examine the factors that impede testing for SARS-CoV-2 (the causative virus among pregnant women), help determine optimal testing strategies by evaluating the necessity of testing for asymptomatic disease in pregnancy, inform prenatal care plans by assessing the full impact of infection, and contribute to a provider's ability to counsel women and create prenatal care plans if they are pregnant or considering pregnancy.

NCT ID: NCT04660708 Active, not recruiting - Pregnancy Related Clinical Trials

Manual Physical Therapy During Pregnancy on Post Partum Perineal Trauma and Pain

Start date: February 15, 2020
Phase: N/A
Study type: Interventional

The purpose of this study is to explore the impact of pelvic floor physical therapy during pregnancy on delivery and the impact on the woman's body and function. Currently there have not been any studies to our knowledge that have examined this relationship and the outcomes for the pregnant patient. The current research that is available is on pelvic floor training and perineal massage during pregnancy with positive outcomes. The questions we are looking to answer include: 1. Does pelvic floor physical therapy during pregnancy decrease the severity of perineal trauma during delivery? 2. Does pelvic floor physical therapy during pregnancy decrease the length of the second stage of labor (pushing)? 3. Does pelvic floor physical therapy during pregnancy decrease the occurrence of emergency C-section?

NCT ID: NCT04633824 Active, not recruiting - Pain Clinical Trials

Health Disparities on the Labor Floor

Start date: February 1, 2021
Phase:
Study type: Observational

The Agency for Healthcare Research and Quality (AHRQ) defines a disparity as a difference or a gap that exist between two groups, which is both statistically significant, larger than 10%, and indicates poor quality for the minority (non-referent) group. Despite advances in public health initiatives and medicine, disparities in healthcare are persistent. For example, in the United States, maternal mortality ratio has doubled since 1987 to 2009 where African American women were 4 times as likely to die from childbirth. Although there was no observed racial disparity in maternal deaths at University of Alabama Birmingham, there is anecdotal experience that may suggest health disparities do exist on the labor floor when examining neuraxial utilization and effectiveness. This retrospective study will seek to examine the successful extension of labor analgesia for cesarean section as it relates to insurance status.

NCT ID: NCT04601987 Active, not recruiting - Pregnancy Related Clinical Trials

Healthy Moms: Prenatal Counseling for Postpartum Health

Start date: February 1, 2021
Phase: N/A
Study type: Interventional

See https://studypages.com/s/healthy-moms-study-765273 This individual-level randomized trial involves pregnant women followed for at least 6 months after delivery, to compare the effects of providing two "attention-control" counseling interventions designed to increase pregnant women's awareness of either: 1. the maternal health benefits of breastfeeding, or 2. the health benefits of smoke-free homes

NCT ID: NCT04586348 Active, not recruiting - Pregnancy Related Clinical Trials

Prenatal Iodine Supplementation and Early Childhood Neurodevelopment

PoppiE
Start date: January 18, 2021
Phase: Phase 4
Study type: Interventional

A randomized controlled trial to determine the effect of reducing iodine from vitamin and mineral supplements for pregnant women who have adequate iodine intakes (>165 μg/d from food alone) on cognitive development of children at 24 months of age.

NCT ID: NCT04568044 Active, not recruiting - COVID-19 Clinical Trials

Evaluation of Humoral Immunity Following COVID-19 in Pregnancy

ImmunoCOVID
Start date: September 16, 2020
Phase:
Study type: Observational

The proposed study is designed to investigate if and how pregnant women infected with Coronavirus Disease-19 (COVID-19) infection go on to develop long-term immunity. In December 2019, a group of people in Wuhan, China presented with symptoms of a pneumonia of an unknown cause that led to the discovery of a new coronavirus called COVID-19. COVID-19 has caused a global pandemic with 7,140,000 confirmed cases and 418,000 deaths as of 13th June 2020. In the United Kingdom (UK), there have been 294,000 cases and 41,662 deaths as of 13th June 2020. In humans, this infection primarily involves the upper part of the lungs, but it can also affect other organs. It causes mild symptoms in the majority of people affected but some people can have severe infections, with some even requiring critical care in hospital. During Severe acute respiratory syndrome (SARS), a previous coronavirus epidemic, pregnant women were disproportionately affected with severe illness. Understanding how the immune system responds long-term to this infection may hold the key to developing better vaccines and efficient treatment plans. Specialised immunity develops when individuals are infected by this and other viruses. The investigators of this study propose that, in pregnancy, this specialised immunity may not behave effectively. This may affect their ability to develop long lasting immunity and make them more vulnerable to re-infection. In this study, the investigators aim to recruit patients across 6 groups including COVID-19 newly infected pregnant women, and people with differing illness severity, mild to moderate, severe/critical, no infection (controls), as well as pregnant women with influenza and those receiving influenza vaccine. The study team will compare COVID-19 in pregnancy with non-pregnant infected and with influenza infected and vaccinated pregnant women. The study team will consent patients in all of these groups to provide a series of blood samples at different time points in a 12-month period.