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High Risk Pregnancy clinical trials

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NCT ID: NCT06279559 Recruiting - High Risk Pregnancy Clinical Trials

Music Therapy and High-risk Pregnancy

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

The objective of this clinical trial is to assess the impact of a music therapy intervention on reactive psychological components related to the risk of preterm birth in hospitalized pregnant women. The primary inquiries it seeks to address are: 1. Can a music therapy intervention during high-risk pregnancy mitigate reactive psychological components (perceived emotional state, state anxiety and trait anxiety, depressive symptoms, perceived stress) related to the risk of preterm birth in hospitalized pregnant women? 2. Does music therapy intervention during high-risk pregnancy positively influence the development of the attachment bond between the mother and the child? 3. How does the risk of preterm birth modulate the future attachment bond between mother and child? Participants will be categorized into three groups: a clinical experimental group (pregnant women at risk of preterm birth undergoing music therapy intervention), a clinical control group (pregnant women at risk of preterm birth receiving standard ward care), and a non-clinical control group (pregnant women with a physiologically progressing pregnancy). Upon signing the informed consent, all three groups will be required to complete five self-report questionnaires assessing perceived positive and negative feelings, depressive symptoms, state anxiety and trait anxiety, perceived stress, and the mother-fetus attachment bond. Subsequently, the clinical experimental group will undergo ten online music therapy sessions, while the clinical control group will receive routine ward care. Following the music therapy sessions, both clinical groups will reassess the aforementioned measures. The non-clinical control group will complete the same self-report questionnaires with the same timing as the clinical groups. All three groups will be contacted three months after childbirth to complete a self-report questionnaire evaluating the postnatal attachment bond. Researchers will compare the outcomes of the two clinical groups to address the first two research questions, while the comparison between the clinical control group and the non-clinical control group outcomes will be employed to answer the third research question.

NCT ID: NCT06151613 Recruiting - Preterm Birth Clinical Trials

Continuous Non-invasive Electrophysiological Monitoring in High Risk Pregnancies

NIEM-O
Start date: November 22, 2023
Phase: N/A
Study type: Interventional

The goal of this single centre cohort intervention study with historical controls, is to investigate the effect of implementing continuous antepartum electrophysiological CTG (eCTG) monitoring at the Obstetric High Care (OHC), on perinatal and maternal outcomes and obstetric care. The main aim is to investigate the effect of both monitoring methods on: - primary outcome: perinatal outcomes (a composite of perinatal mortality or major neonatal morbidity) until hospital discharge - secondary outcomes: Maternal mortality, neonatal morbidity, satisfaction for both patient and caregiver, duration of pregnancy, switch of monitoring method, duration of admission to the OHC, timing (planned or emergency) and number of obstetric interventions (such as caesarean section), and admission and duration of admission to the NICU (neonatal intensive care unit). Eligible women will be prospectively included in the cohort receiving standard treatment: CTG monitoring intermittent up to three times a day. From these eligible women, a random sample (464) of the prospective cohort (511) will be offered to receive a new monitoring method: 24/7 eCTG monitoring. In order to strengthen the comparison between the two groups (eCTG and standard treatment), additional data from 1400 women who received standard treatment in 2014-2019 will be collected retrospectively.

NCT ID: NCT06130150 Recruiting - Anxiety Clinical Trials

Sexual Function in High-risk Pregnant Women

Start date: July 10, 2021
Phase:
Study type: Observational [Patient Registry]

Our aim with this study is to evaluate the sexual functions of pregnant women whose pregnancies are defined as high-risk pregnancies and whose pregnancies are followed by perinatology specialists.

NCT ID: NCT05035160 Recruiting - Pregnancy Clinical Trials

UCLA Perinatal Biospecimen Repository

Start date: July 30, 2021
Phase:
Study type: Observational [Patient Registry]

The purpose of this investigator-initiated prospective observational cohort study is to establish the new UCLA Perinatal Biospecimen Repository (Perinatal Repository) for collection, storage, and distribution of the human data and biospecimens of the participants with perinatal pathology. The secure and shared high-quality resource of clinical data and biological specimens (Repository Materials), across pregnancy pathology related to research protocols at the Afshar's Lab will be created. Core variables of interest include clinical characteristics and relevant biological samples. Intention to collect perinatal data is aiding the efficiency and effectiveness of de-identified biorepository for pregnancy-at-risk outcome research. The primary aims of the project are: - To design the Case Report Forms (CRFs) for the clinical and biospecimen data. - To create and update the project-specific policies, agreements, and Standard Operating Procedures (SOPs). - To develop the data management system to assure personal health information de-identification, data integrity, participants welfare, and protocol compliance. - To develop and implement a quality management system for the Repository. - To collect and record in the Repository protocol-related clinical information. - To organize a consistent system to bank high-quality biospecimens while protecting participant-donor safety and privacy. - To establish the policies and procedures for Repository Materials dissemination and research collaboration. - To analyze the scientific results of the Repository creation. The secondary aim of the study is to provide a mechanism to store and share for research purposes the de-identified biospecimen and information about participants at risk for adverse pregnancy outcomes.

NCT ID: NCT04783597 Recruiting - Pre-Eclampsia Clinical Trials

Early Prediction of Preeclampsia Using arteriaL Stiffness in High-risk prEgnancies

PULSE
Start date: July 12, 2021
Phase:
Study type: Observational

Despite advances in obstetric care, preeclampsia (PE) remains the leading cause of maternal death and disability in both developed and developing countries, contributing to over 70,000 maternal and 500,000 fetal deaths annually worldwide. PULSE was designed using a preventative medicine approach, focusing on improving early detection of PE as opposed to managing symptoms after onset. The study aims to uncover the earliest possible signs of PE using a combination of novel clinical tools and established diagnostic techniques to better identify, track, and manage high risk pregnant women. Specifically, PULSE will be examining the incorporation of a non-invasive test for the measurement of arterial stiffness, which has been shown to be predictive of hypertensive disorders. This test, in combination with a wide range of blood biomarkers, detailed ultrasound imaging, and a comprehensive battery of physical and mental health questionnaires, represents the largest, most comprehensive preventative PE study to date. The results of this work has the potential to revolutionize the way PE and other hypertensive disorders of pregnancy are managed and treated and can serve to inform the design of future preventative clinical research studies.

NCT ID: NCT04203082 Recruiting - High Risk Pregnancy Clinical Trials

Cognitive Behavioral Intervention to Reduce Procedural Anxiety Among Woman With High Risk Pregnancies With Scheduled Cesarean Deliveries

Start date: July 23, 2020
Phase: N/A
Study type: Interventional

The goals of this study are to determine the feasibility and efficacy of a brief, single-session cognitive-behavioral intervention for reducing preoperative and postoperative anxiety and for determining satisfaction with the delivery process in pregnant women scheduled for Cesarean delivery due to complications with their pregnancy. This will be done through a combination of psychoeducation and exposure therapy, where the participants will be walked through the steps of a Cesarean delivery in an operating room that mimics where the patient would actually be delivering. Follow-up will occur during the immediate and extended postpartum periods to determine satisfaction and levels of anxiety.

NCT ID: NCT03775954 Recruiting - Clinical trials for Congenital Heart Disease

Fetal Electrophysiologic Abnormalities in High-Risk Pregnancies Associated With Fetal Demise

Start date: July 1, 2018
Phase:
Study type: Observational

Each year world-wide, 2.5 million fetuses die unexpectedly in the last half of pregnancy, 25,000 in the United States, making fetal demise ten-times more common than Sudden Infant Death Syndrome. This study will apply a novel type of non-invasive monitoring, called fetal magnetocardiography (fMCG) used thus far to successfully evaluate fetal arrhythmias, in order to discover potential hidden electrophysiologic abnormalities that could lead to fetal demise in five high-risk pregnancy conditions associated with fetal demise.

NCT ID: NCT03562598 Recruiting - High Risk Pregnancy Clinical Trials

Frequency of Performing Umbilical Artery Doppler in the Third Trimester in High Risk Pregnancy

Start date: January 1, 2018
Phase: N/A
Study type: Interventional

The aim of the current study was to produce a high quality evidence on the best frequency of performing umbilical artery Doppler for high risk pregnant women in the third trimester.

NCT ID: NCT03220750 Recruiting - High Risk Pregnancy Clinical Trials

University Hospital Advanced Age Pregnant Cohort

UNIHOPE
Start date: March 28, 2017
Phase: N/A
Study type: Observational

The University Hospital Advanced Age Pregnant (UNIHOPE) Cohort is the major part of the National Key Research and Development Program on Reproductive Health & Major Birth Defects Control and Prevention Project, which is funded by the Ministry of Science and Technology of China. The Project is led by Prof. Zhao Yangyu, from the Department of Gynecology & Obstetrics, Peking University Third Hospital, and the UNIHOPE cohort is led by Prof. Jian-meng Liu, the Co-PI of the Project.

NCT ID: NCT03152058 Recruiting - Clinical trials for Pregnancy Complications

IMPACT Study: IMProve Pregnancy in APS With Certolizumab Therapy

Start date: May 17, 2017
Phase: Phase 2
Study type: Interventional

This treatment trial evaluates the addition of an anti-tumor necrosis factor-alpha drug, certolizumab, to usual treatment (a heparin agent and low-dose aspirin) in pregnant women with antiphospholipid syndrome (APS) and repeatedly positive tests for lupus anticoagulant (LAC) to determine if this regimen will improve pregnancy outcomes. All enrolled patients will receive certolizumab, and pregnancy outcomes will be compared to those of women with APS and repeatedly positive tests for LAC enrolled in a previous study by the investigators.