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Pregnancy, High Risk clinical trials

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NCT ID: NCT06366711 Not yet recruiting - Telemedicine Clinical Trials

Remote Telemedicine Fetal Monitoring Feasibility Study

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

During pregnancy, certain conditions may arise that mean regular monitoring of both mother and baby are needed to ensure timely interventions and avoid the need for further treatments. These situations include problems with high blood pressure, obstetric cholestasis (characterised by liver-related itchiness), preterm premature rupture of membranes (PPROM), and a history of stillbirth. Monitoring typically involves assessing the mother's blood pressure and urine, recording the baby's heart rate over a specific duration, and conducting regular ultrasound scans. Such monitoring can require frequent hospital visits, often multiple times a week, which can be very time consuming. More recently, new technology has emerged, enabling remote monitoring of mother and baby outside of the hospital setting, such as their own home. However, research on these technologies is still very limited. Our study aims to address this research gap by inviting women with the above conditions to volunteer for home-based monitoring, alongside their routine hospital care. Participants will be divided into three groups: one group will use transducers, attached to the mothers tummy, to capture the baby's heartbeat; another group will use a handheld ultrasound device connected to their mobile phones, allowing them to observe the baby; and a third group will use both devices. All device information will be transmitted securely to the healthcare professional for analysis. The investigators aim to assess the feasibility of conducting remote monitoring of mother and baby, whilst understanding how acceptable the technology is received. Importantly, the data collected will only be evaluated by the research team and will not be intended to influence patient's current planned antenatal care. Women will receive comprehensive training on the devices. The study will additionally gather feedback from participating women through questionnaires, both at the study's outset and its conclusion, regarding their experiences and emotions related to the research.

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: 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: NCT05388643 Not yet recruiting - Clinical trials for Pregnancy, High Risk

Early Detection of Gestational Diabetes Mellitus in Pregnancy

Start date: October 1, 2024
Phase: N/A
Study type: Interventional

The purpose of this study is to develop an implementation protocol and test the feasibility and acceptability of a first trimester screening protocol for the early detection of gestational diabetes mellitus (GDM).

NCT ID: NCT05317585 Not yet recruiting - Clinical trials for Pregnancy, High Risk

Continuous Glucose Monitor Use in Pregnancy

Start date: October 1, 2024
Phase: N/A
Study type: Interventional

The purpose of this study is to perform a randomized controlled trial among 180 pregnant women with type 2 diabetes mellitus (T2DM) comparing continuous glucose monitor (CGM) use to the standard of care of multiple daily fingerstick glucose monitoring and its impact on large for gestational age infants, maternal glycemic control, patient satisfaction, and additional adverse perinatal outcomes.

NCT ID: NCT04693572 Not yet recruiting - Anesthesia Clinical Trials

Anesthetic Considerations for Repeat Cesarean Section - a Prospective Study

Start date: January 2021
Phase:
Study type: Observational [Patient Registry]

The purpose of this study is to examine the anesthetic considerations and outcomes during repeated caesarean section and to compare such considerations in low-order vs high-order repeated caesarean sections.

NCT ID: NCT03985618 Not yet recruiting - Obesity Clinical Trials

The MODE Trial: Planned Caesarean Section Versus Induction of Labour for Women With Class III Obesity

MODE
Start date: September 1, 2019
Phase: N/A
Study type: Interventional

Canadian guidelines recommend that women with a pre-pregnancy body mass index (BMI) at or above 40 kg/m2 deliver by their due date. When delivery is planned prior to spontaneous labour, there are two options: planned induction of labour or pre-labour Caesarean (C-section). However, it is not yet clear whether induction of labour or planned pre-labour C-section is the best option for this population. The MODE Trial aims to assess the feasibility of conducting a larger-scale trial of planned mode of delivery in first time mothers who have a BMI >=40kg/m2, and obtain preliminary data on health outcomes for moms and babies following delivery by either planned C-section or induction of labour.