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Pregnancy, High Risk clinical trials

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NCT ID: NCT05790252 Recruiting - Pregnancy Related Clinical Trials

Transdermal Patch for BupRenorphine Induction DurinG PrEgnancy (Patch BRIDGE)

Patch BRIDGE
Start date: June 26, 2023
Phase: Phase 3
Study type: Interventional

The goal of this clinical trial is to compare buprenorphine patch for induction (starting) of buprenorphine in pregnant patients with opioid use disorder. The main questions it aims to answer are: 1. Is there a buprenorphine induction method that results in the least moderate-to-severe opioid withdrawal symptoms in pregnant patients with opioid use disorder? 2. Is there a buprenorphine induction method that results in a higher treatment success rate? Under normal circumstances, patients who are planning to start sublingual (under the tongue) buprenorphine for opioid use disorder must first go into withdrawal to start the medication safely. Study participants will be given a buprenorphine patch during the required withdrawal period before starting sublingual treatment, and be surveyed daily by phone to assess their withdrawal symptoms. They will also be followed at prenatal appointments to evaluate treatment success based on urine drug screen results. Researchers will compare patients receiving no buprenorphine patch according to the current standard care protocol.

NCT ID: NCT05786235 Recruiting - Preeclampsia Clinical Trials

Patients Pregnant Women With or Without Primary Antiphospholipid Antibody Syndrome

Start date: December 6, 2022
Phase:
Study type: Observational

The purpose of the study is to evaluate the ability of placental angiogenesis markers to predict the risk of PE in pregnancy in women with primary APS. To construct reference intervals of placental angiogenesis markers specific to women affected by primary APS in pregnancy by measuring the levels of sFlt-1and PlGF in serum maternal serum and their sFlt-1/PlGF ratio during the trimesters of gestation (I TM, II TM and III TM). For this aim the study will involve recruiting two groups of subjects, one will be cases and one will be controls.

NCT ID: NCT05739136 Not yet recruiting - Pregnancy Related Clinical Trials

MYFEMBREE®: A Retrospective Cohort Study Using an Administrative Healthcare Database to Assess Pregnancy Outcomes in Women Treated With Relugolix Combination Therapy

Start date: January 2025
Phase:
Study type: Observational

This is a retrospective cohort study that will be conducted using secondary de-identified electronic healthcare data (EHD) that originally were collected for the purposes of health insurance billing and/or routine patient care from healthcare providers (HCPs). The study is designed to evaluate the association between relugolix combination therapy (relugolix 40 mg, estradiol 1 mg, and norethindrone acetate 0.5 mg) exposure during pregnancy and subsequent fetal and infant outcomes.

NCT ID: NCT05739123 Recruiting - Pregnancy Related Clinical Trials

Relugolix Pregnancy Registry: An Observational Study of the Safety of Relugolix-Containing Therapy Exposure in Pregnant Women and Their Offspring

Start date: May 8, 2023
Phase:
Study type: Observational [Patient Registry]

The Relugolix Pregnancy Registry is a prospective, observational cohort study designed to evaluate the association between relugolix-containing therapy exposure during pregnancy and subsequent maternal, fetal, and infant outcomes. Data will be collected from enrolled pregnant women and the healthcare providers (HCPs) involved in their care or the care of their infants, if applicable.

NCT ID: NCT05670769 Not yet recruiting - Clinical trials for Gestational Diabetes

The Effect of Home Midwifery Care Given to Pregnant Women Diagnosed With Gestational Diabetes on Attitudes and Self-Care

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

Since gestational diabetes carries the risk of serious complications for the mother and fetus, it is very important to follow up the pregnancy carefully and consciously. Home follow-up and prenatal care of these pregnant women, whose outpatient follow-up is continued without hospitalization, gains great importance. This study was planned as a randomized controlled experimental study to determine the effects of home midwifery care based on the continuous midwifery care model for pregnant women diagnosed with gestational diabetes, on the attitudes and self-care of pregnant women. The universe of this research, which will be carried out in a randomized controlled experimental type, will consist of pregnant women who applied to Çukurova University Balcalı Hospital Health Application and Research Center Gynecology and Obstetrics Department Pregnancy Polyclinic. The sample number was calculated by the Sample Size Calculator analysis and it was planned to include 24 participants in the experimental group and 24 participants in the control group. Single-blind randomized assignment and block randomization will be performed to avoid selection bias. The research will be conducted in the form of pre-test and post-test. The pre-test will be applied at the first encounter before the midwifery training, and the post-test will be applied after the 6th training. Data; It will be collected with the Pregnant Introductory Form, Intention, Attitude and Behavior Scale in Gestational Diabetes and Diabetes Self-Care Activities Questionnaire. Statistical Program for Social Science 22 will be used in data analysis. The data will be analyzed with appropriate analysis methods after testing for normality. The main subject of this research is to improve maternal and fetal health by providing continuous midwifery care at home for pregnant women who are diagnosed with gestational diabetes and are in the risky pregnancies group. With individual and continuous midwifery care provided at home, the self-care of women is strengthened and the intention, behavior and attitude towards both pregnancy and the health problem she has experienced are positively affected, contributing to the reduction of possible complications and providing a cost-effective service reveals the importance and necessity of the research.

NCT ID: NCT05662462 Not yet recruiting - Type2diabetes Clinical Trials

Successfully Achieving and Maintaining Euglycemia During Pregnancy for Type 2 Diabetes Through Technology and Coaching

Start date: May 2024
Phase: N/A
Study type: Interventional

The ACHIEVE RCT will measure the effect of the intervention (mHealth app with CGM, provider dashboard, and care team coaching) compared to current standard care (prenatal visits, self-monitored blood glucose, and certified diabetes care and education specialist) on achieving glycemic control (hemoglobin A1c <6.5% in the third trimester). We hypothesize a 25% absolute increase in the proportion of participants in the intervention group who will meet the target hemoglobin A1c <6.5% in the third trimester compared to the standard care group

NCT ID: NCT05656352 Active, not recruiting - Clinical trials for Pregnancy, High Risk

Validation of a Non-invasive Hemoglobin Measurement Device in Pregnancy and Postpartum in Kenya, Pakistan, and Zambia

Start date: September 22, 2022
Phase:
Study type: Observational

Accurate, precise, and comparable hemoglobin measurements is of great importance, both for clinical value in diagnosing anemia and ensuring pregnant women receive appropriate treatment. The Masimo Total Hemoglobin SpHb® is a continuous and non-invasive handheld device with an optical sensor placed on the finger that measures hemoglobin levels using pulse oximetry. The objective of this study is evaluate the compatibility of hemoglobin measurements between SpHb and the gold standard laboratory-based assessment (complete blood count assessed via five-part autoanalyzer) throughout the course of pregnancy and at six weeks postpartum.

NCT ID: NCT05653362 Completed - Clinical trials for Pregnancy, High Risk

Coconut Oil vs. Commercial Ultrasound Gel In Obstetric Ultrasounds

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

The goal of this randomized controlled trial is to compare the use of coconut oil with commercial ultrasound gel for obstetrical ultrasounds. The main questions it aims to answer are: 1. To evaluate the quality of ultrasound images obtained using coconut oil compared with commercial ultrasound gel. 2. To access patient acceptability of coconut oil as compared to commercial ultrasound gel. Participants will: 1. Allow a total of 6 study images to be obtained; 3 using coconut oil and 3 with commercial ultrasound gel. 2. Fill out a 10-question, 5-point Likert scale survey following their ultrasound with both coupling mediums to compare acceptability.

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: NCT05573009 Completed - Clinical trials for Depression, Postpartum

The Effect of Stress Reduction Program on Pregnancy Process and Mental Health in High Risk Pregnant Women

Start date: March 1, 2022
Phase: N/A
Study type: Interventional

Introduction Pregnancy and giving birth to an infant is a physiological process as well as it is also a transition of life, and a stressful period of time with a significance in the life of woman. This period is evaluated as a developmental crisis for the woman, and for her family. High-risk pregnant women are at the forefront of the individuals who need to be supported the most during the transition to motherhood.The presence of a physiological, emotional and psychosocial condition that endanger the health and life of the pregnant and/or fetus and increases the risk of illness and death is defined as "high-risk pregnancy". Exposure to obstetric complications is known to be associated with the later development of psychiatric disorders. In the literature review, it is seen that there are few studies in which CBT and mindfulness-based interventions are applied to reduce stress, anxiety and depression in risky or risk-free pregnant women. However, no CBT-based stress reduction program applied to high-risk pregnant women has been found in our country. A stress reduction program based on cognitive behavioral interventions during the transition to motherhood can contribute to the protection of maternal mental health and psychological well-being in pregnant women, and may help for healthy pregnancy and birth outcomes. Research Aim This study was planned to examine the effect of cognitive behavioral approach-based stress reduction program on pregnancy process and maternal mental health to be applied to high-risk pregnant women. Research Type The study was planned as an experimental study with a randomized control group including pre-test, post-test and follow-up measurements to examine the effect of "stress reduction program based on cognitive behavioral approach" on the maternal mental health, pregnancy, and childbirth process of the high risk pregnant women.