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Pregnancy clinical trials

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NCT ID: NCT06233773 Not yet recruiting - Pregnancy Clinical Trials

The Effect of Kinesio Taping and Manual Lymph Drainage on Pregnant Women With Restless Legs Syndrome

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

Restless Leg Syndrome, a progressive and recurrent chronic sensorimotor disorder that creates an irresistible urge to move the legs and a feeling of discomfort, is seen in 15.4-26.0% of pregnant women in our country. Restless Leg Syndrome has negative effects on sleep, mood, cognitive health, daily activities and behavior in pregnant women; It can also cause preeclampsia, difficult labor, and cesarean delivery. Therefore, it is important for pregnant women with Restless Leg Syndrome to be treated appropriately. It is recommended that pregnant women use non-pharmacological treatments as they are not risky for fetal health. Kinesio taping and manual lymphatic drainage methods are used non-pharmacologically to support venous-lymphatic drainage and manage pain. These methods are economical, reliable and easy to apply. However, no study has been found in which Kinesio taping or manual lymphatic drainage was applied to a patient group with Restless Leg Syndrome during or outside pregnancy. The aim of this project is to determine the effect of Kinesio taping and manual lymphatic drainage on Restless Legs Syndrome severity, sleep quality and psychological well-being in pregnant women with Restless Legs Syndrome.

NCT ID: NCT06199154 Not yet recruiting - Pregnancy Clinical Trials

Induction of Labor in Morbidly Obese Patients

Start date: May 2024
Phase: Early Phase 1
Study type: Interventional

The goal of this randomized control trial is to compare different doses of Misoprostol (25 mcg vs 50 mcg) in induction of labor (IOL) in morbidly obese patients with BMI >40. It is known that morbid obesity is a risk factor for failed IOL and ultimately cesarean delivery (CD.) If the rates of vaginal delivery in this population can improve, then surgical morbidity can be reduced in these patients.

NCT ID: NCT06046703 Not yet recruiting - Pregnancy Clinical Trials

Diet Quality of Pregnant Women With a Strict Plant-based Diet Versus an Omnivorous Diet

Start date: January 1, 2025
Phase:
Study type: Observational

The goal of this observational study is to compare the nutritional intake among pregnant women with a strict plant-based diet versus an omnivorous diet. The main aim is to compare vitamin B12 intake. Participants will be asked to: - fill out a health questionnaire - fill out a three-day food diary - undergo blood sampling Researchers will compare pregnant women with a strict plant-based diet and pregnant women with an omnivorous diet to see if their nutritional intake is comparable.

NCT ID: NCT06015425 Not yet recruiting - Depression Clinical Trials

tDCS in Depression in Perinatal Women

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

The goal of this clinical trial is Real-world data(RWD) collection and Real-world evidence(RWE) clinical demonstration study of Transcranial direct current stimulation(tDCS) for the treatment of depression in perinatal women. Participants will apply tDCS by themselves for 4 weeks at home. Researchers will compare Visit 1 to Visit 3 in one group.

NCT ID: NCT05934318 Not yet recruiting - Pregnancy Clinical Trials

L-ArGinine to pRevent advErse prEgnancy Outcomes (AGREE)

AGREE
Start date: September 30, 2023
Phase: N/A
Study type: Interventional

There are few safe, effective, and affordable interventions to improve pregnancy outcomes in low resource settings where the highest rates of poor birth outcomes occur. L-citrulline is naturally found in many foods and is changed into another important amino acid, L-arginine, in the body. L-arginine is important for the growth of a healthy placenta and healthy baby. Adding L-citrulline to the diets of pregnant women may be an effective and affordable way to improve the health of their babies.The goal of the AGREE trial is to test whether a dietary supplement containing a common food component, an amino acid called L-citrulline, can help pregnant Kenyan women at risk of malaria have healthier pregnancies and healthier babies. 2,960 pregnant Kenyan women will be enrolled and randomly assigned to take either a twice daily dietary supplement containing L-citrulline or a placebo supplement without additional L-citrulline. Maternal participants will be seen every month until delivery and at weeks 1 and 6 after birth. Infants will also be followed up at ages 6, 12, 18, and 24 months. The primary outcome of the study is 'adverse pregnancy outcome', a composite of foetal loss (miscarriage or still birth), preterm birth, low birth weight, small for gestational age or neonatal mortality. The results of the AGREE trial could help to guide obstetric and public health policy and provide a sustainable solution that could be implemented at the community level.

NCT ID: NCT05929586 Not yet recruiting - Pregnancy Clinical Trials

Digital Data Linkage and Scheduling to Track Pregnancy With or Without Community Data Use to Increase Antenatal Clinic Uptake in Western Kenya.

C-it-DU-it
Start date: October 2023
Phase: N/A
Study type: Interventional

The investigators propose to increase ANC uptake through a health systems strengthening approach that links digital data platforms and trains community Work Improvement Teams (WITs) to use these data to identify problems and come up with local solutions. Our short name C-it DU-it (pronounced "see-it; do-it") is an acronym intended to convey 'seeing' linked data (C-it) and 'doing' or acting on the data (DU-it). The trial design is a 2-arm, cluster-randomised controlled superiority trial in Homa Bay County to determine the efficacy of 'C-it DU-it' intervention (data use arm) to increase ANC contacts when compared to the 'C-it' enhanced standard of care (control arm).

NCT ID: NCT05910580 Not yet recruiting - Pregnancy Clinical Trials

Improving Alcohol and Substance Use Care Access, Outcome, Equity During the Reproductive Years

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

The goal of this clinical trial is to test the effectiveness of evidence-based Screening, Brief Intervention, and Referral to Treatment (SBIRT) among adult patients who screen positive to one or more risky alcohol or substance use behaviors while seeking care at a sexual and reproductive health (SRH) clinic. The main questions it aims to answer are: - Does SBIRT impact patients' alcohol and substance use, SRH, mental health, physical health, quality of life, and wellbeing? - Does SBIRT effectiveness differ by ethnicity, socioeconomic status, age, gender, and urbanicity? - Does SBIRT effectiveness differ by delivery mode (in-person vs. telemedicine)? Participants will receive in-person SBIRT, telemedicine SBIRT, or usual care. Participants will complete surveys at interviews at baseline, 30 days, and 3 months. Researchers will compare patients who received SBIRT to patients who receive usual care to see if patients who receive the SBIRT intervention have a greater reduction in negative outcomes as compared to those who receive usual care. In this setting, usual care consists of basic quantity and frequency questions asked inconsistently as part of the admission process and varying by provider, with no standardized approach to screening, treatment, follow-up, or referral.

NCT ID: NCT05904925 Not yet recruiting - Pregnancy Clinical Trials

Pilates for the Prevention of Musculoskeletal Complaints During Pregnancy

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

The goal of this pilot randomized controlled trial with economic evaluation is to evaluate the viability of Pilates in the prevention of musculoskeletal complaints, throughout the entire gestational period, in pregnant women. The main question it aims to answer is if it is feasible to perform exercises during the entire gestational period to prevent musculoskeletal disorders. Participants will be assessed primarily for acceptability, suitability, feasibility, and fidelity, and secondarily for the occurrence of musculoskeletal complaint and the number of days from randomization on which this musculoskeletal complaint occurred, type of delivery and costs. Then, participants will be randomized into two groups: the usual care group, which will receive an educational booklet with information about the usual care during pregnancy, and the Pilates group, which will receive the same educational booklet and will participate in a specific Pilates exercise program for the gestational period, twice a week, throughout the pregnancy.

NCT ID: NCT05877131 Not yet recruiting - Pregnancy Clinical Trials

Evaluate Efficacy Levobupivacaine 0.125% Versuss Ropivacaine 0.2% in Hemodynamic Alterations in Labor and Fetal Repercussions

Start date: June 1, 2023
Phase: Phase 4
Study type: Interventional

INTRODUCTION: Most studies on analgesia in pregnant women in labor mainly evaluate the effect of anesthetics on pain, mentioning hypotension as a side effect without investigating its impact on fetal well-being. The objective of the present study is to evaluate the efficacy of the use of low doses of local anesthetic (LA) to prevent hemodynamic alterations that manifest as a loss of fetal well-being. METHODOLOGY/DESIGN: It is a randomized clinical trial. Patients will be pregnant women in labor (dilation period) who want epidural anesthesia (EA), who will randomly receive 0.125% levobupivacaine (Group L) versus 0.2% ropivacaine (Group R). In both groups, controls of hemodynamic parameters and their relationship with changes in fetal heart rate (FHR) and cardiotocographic recording (RCTG) will be carried out during the first 60 minutes after the administration of the local anesthetic via the epidural route. In case of hypotension and/or subsequent FHR and RCTG alterations, they will also be recorded. The follow-up period will extend from the moment the patient enters the delivery room and requests epidural anesthesia until the moment the patient is discharged from the delivery room. The percentage of patients with hemodynamic alterations will be evaluated as a primary result, as well as the percentage of patients whose hemodynamic alterations are related to changes in FHR and RCTG, when using low doses of LA. In the following will also be evaluated in relation to analgesia, the onset time, level reached and degree of satisfaction; and various intra and postpartum side effects. DISCUSSION: Both groups of pregnant women in labor will be studied in order to obtain data on the potential impact of the use of low doses of local anesthetic via the epidural route on hemodynamic parameters and the state of well-being of the fetus.

NCT ID: NCT05806372 Not yet recruiting - Clinical trials for Cardiovascular Diseases

Biomarkers of CVD Dysfunction in Hypertensive Disorders of Pregnancy

Start date: October 15, 2023
Phase:
Study type: Observational

Profound and concomitant cardiovascular hemodynamic changes, necessary to support fetoplacental development and its increasing supply demands, occur during a physiological pregnancy characterized by an increase in cardiac output, heart rate and plasma volume, and fall in vascular resistance and blood pressure. The result of these changes is a volume overload that will lead to a compensatory transient left ventricular eccentric hypertrophy. This, together with the pro-inflammatory state typical of pregnancy, represents the pregnancy as a stress-test for the maternal cardiovascular system. Pregnancies complicated by hypertensive disorders of pregnancy (HDP), particularly those with early onset and/or complicated by intrauterine fetal growth restriction (FGR), are characterized by a cardiovascular maladaptation. Women who experienced HDP in pregnancy, especially pre-eclampsia (PE), more often develop later in life ischemic heart disease, hypertension and stroke, obesity, dyslipidemia, and end-stage renal disease. Regardless its clinical impact, very little knowledge is available on the mechanisms by which PE could lead to cardiovascular disease (CVD), and, especially, to heart failure after pregnancy. Preliminary results suggest a cross-talk between pregnancy-induced biomarkers and cardio-vascular system. Particularly, cultures of neonatal rat cardiomyocytes and fibroblasts were used to investigate the role of the serum of women with HDP in regulating their proliferation. 5-ethynyl-2'-deoxyuridine (EdU) was administered to label DNA synthesis in proliferating cells. After 3 days of in vitro culture, EdU incorporation was analyzed upon immunofluorescence staining using specific antibodies by high content microscopy. A possible protective effect exerted by the selected sera against apoptosis was evaluated, as well, by Caspase activation. Moreover, the effect of cardiomyocytes and fibroblasts proliferation and apoptosis on maternal hemodynamic parameters was evaluated using median regression models. These data show that the serum of women with HDP triggers a net increase in the percentage of proliferating cardiomyocytes compared to controls. Moreover, there were relationship between cardiomyocytes and fibroblasts proliferation and maternal hemodynamics parameters thus, supporting the hypothesis that the serum of women with HDP may contain factors capable of stimulating cardiac cells in response to the cardiovascular stress-test