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Fetal Growth Restriction clinical trials

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NCT ID: NCT06104748 Recruiting - Clinical trials for Fetal Growth Restriction

A Cohort of Severe Placental Fetal Growth Restriction (CoSFGR)

Start date: August 10, 2023
Phase:
Study type: Observational [Patient Registry]

Through multicenter study, the investigators aim to refine the process for precise prenatal diagnosis of fetal growth restriction (FGR), establish a cohort for severe maternal vascular malperfusion (MVM)-FGR, and conduct follow-up study to identify prognostic factors associated with both short-term and long-term outcomes.

NCT ID: NCT05601375 Recruiting - Clinical trials for Fetal Growth Restriction

Speckle Tracking Echocardiography in Infants, Prenatally and Postnatally

STIPP
Start date: September 12, 2022
Phase:
Study type: Observational [Patient Registry]

Comparison of prenatal and postnatal cardiac function assessed by echocardiography using pulsed wave Doppler, Tissue Doppler and speckle tracking (strain and strain rate) between foetuses/neonates with a structural heart disease, with an fetal growth restriction (FGR) and healthy fetuses/neonates.

NCT ID: NCT05423665 Recruiting - Clinical trials for Fetal Growth Restriction

Speckle Tracking Echocardiography as a Tool for Early Diagnosis of Impaired Fetal Growth Twin Pregnancies

HEART
Start date: June 22, 2023
Phase:
Study type: Observational

In this project there are 2 time points during the pregnancy included, namely at 21 weeks and 30 weeks of gestation, to measure the predictive values of FGR, strain and strain rate. The fetal growth parameters will be collected at the same time points, to define the growth (differences) throughout gestation of both fetuses. A maternal blood sample will be taken at 21 weeks of gestation to identify the level of exposure to air pollution (black carbon) and the level of biochemical markers of placental dysfunction. Doppler ultrasounds will be used for antenatal identification of placenta insufficiency. At birth, umbilical cord blood and the placenta will be collected. The placenta will be examined, to identify morphological findings which are associated with FGR. The umbilical cord blood and placental biopsy will be used for the level of exposure to air pollution and the level of oxidative stress. One to three days after birth, neonatal strain and strain rate will be measured to define postnatal cardiac remodeling as well as the neonatal blood pressure as cardiovascular risk factor.

NCT ID: NCT05034861 Recruiting - Clinical trials for Fetal Growth Restriction

COmputerized CTG Self-MOnitoring Versus Standard Doppler Assessment in Late-onset FGR: COSMOS Study

COSMOS
Start date: December 13, 2022
Phase: N/A
Study type: Interventional

Fetal growth restriction is one of the major causes of perinatal morbidity, mortality and adverse neurological outcome. Growth restricted fetuses do not reach their potential due to multiple factors. Although early (<32 weeks' gestation) FGR is associated with the highest risk of adverse outcomes, late FGR (≤ 32 weeks' gestation) is more common in daily maternal-fetal medicine care. Despite its' prevalence, optimal standard for monitoring differs between the centers and may be difficult in case of limited access to advanced perinatal care. We present a protocol for COmputerized CTG Self-MOnitoring versus Standard Doppler assessment in Late-onset FGR (COSMOS) trial, which is a prospective, cross-over, open-label and randomized trial that compares two different protocols for late-onset FGR observation. All women carrying fetuses with late-onset FGR with positive end-diastolic flow in umbilical artery will be invited to participate in the randomized trial. Patients will be randomly divided into two groups: CTG - a group that will receive electronic device for cCTG home assessment, and Doppler - a group that will be monitored according to standard Doppler velocimetry criteria. Further management will depend on the arm of the study. Pregnancy and neonatal outcomes will be collected and analyzed.

NCT ID: NCT04438668 Recruiting - Clinical trials for Fetal Growth Restriction

Evaluation of the Safety and Performance of Centaflow

Start date: June 3, 2020
Phase: N/A
Study type: Interventional

The aim of this study is to evaluate the safety and performance of an acoustic approach based on skin-contact microphones as a routine assessment of placental vascular function as predictor of fetal growth restriction.

NCT ID: NCT04399434 Recruiting - Gut Microbiota Clinical Trials

Gut Microbiota, SCFAs and Glucolipid Metabolism in Pregnant Women With Abnormal Fetal Size and Their Newborns

Start date: January 1, 2019
Phase:
Study type: Observational

Abnormal fetal size includes fetal growth restriction and fetal macrosomia. Onset is closely related to maternal nutrition metabolism. The specific correlation and mechanism is unclear, and there are no effective measures for early diagnosis and treatment. Previous study found that maternal gut microbiota participates in the material metabolism throughout the pregnancy. Insulin sensitivity in pregnant women, and intrauterine environment under abnormal blood glucose and lipid metabolism are important for the gut microbiota of newborns and even they grow up. However, changes in gut microbiota are the cause of the disease or the outcome is not yet clear. Short chain fatty acids (SCFAs) are produced from soluble dietary fibers in the diet by colon bacteriolysis. Studies have found that gut microbiota can regulate insulin sensitivity and glucose and lipid metabolism disorders through SCFAs. Therefore, this research group uses the gut microbiota as a new idea to studythe relationship of gut microbiota characteristics and level's change of SCFAs with glucolipid metabolism and insulin sensitivity in pregnant women with abnormal fetal size and their newborns through 16S-rRNA high-throughput sequencing, pyrosequencing, and gas chromatography-mass spectrometry, so we can reveal the role of gut microbiota in the pathogenesis of abnormal fetal size and explore targeted rational dietary adjustment and SCFAs reconstruction of gut microbiota to improve maternal and neonatal pregnancy outcomes.

NCT ID: NCT04394611 Recruiting - Clinical trials for Fetal Growth Restriction

Metals and in Fetal Growth Restriction

FGR&metals
Start date: May 30, 2020
Phase:
Study type: Observational

Introduction: Intrauterine fetal growth restriction (FGR) is a condition in which the fetus does not realize its growth potential in the uterus. Heavy metals important pollutants produced from anthropogenic activities, has been suggested to be embryotoxic and fetotoxic in a lot of studies. However, the causes of fetal growth restriction are little known and heavy metals merit further investigation. The investigators will be tested whether fetal growth restriction was associated with exposure to these metals/vitamins. Methods: This study was designed to determine maternal plasma/urine/hair, cord plasma, placenta and breast milk tin (Sn), manganese (Mn), Vanadium (V), Magnesium (Mg), cobalt (Co), nickel (Ni), arsenic (As), chromium (Cr), cadmium (Cd), lead (Pb), mercury (Hg), antimony (Sb), aluminium (Al), zinc (Zn), copper (Cu), selenium (Se), iron (Fe), vitamin D, vitamin A, vitamin B12 and folate concentrations in women with FGR (n=55) compared to those of volunteer healthy pregnant women (n=55). These heavy metals concentrations measured using inductively coupled plasma-mass spectrometry were compared.

NCT ID: NCT04311749 Recruiting - Clinical trials for Fetal Growth Restriction

Expanded NIPT for Pregnancy Complications

Start date: February 12, 2020
Phase:
Study type: Observational

This study evaluates the utility of expanded panel non-invasive prenatal testing (NIPT) in detecting confined placental mosaicism of rare autosomal trisomies among pregnancies with placentally-mediated complications, including fetal growth restriction and severe preeclampsia.

NCT ID: NCT04215107 Recruiting - Clinical trials for Fetal Growth Restriction

Fetal Distribution of Feto-placental Blood Flow Related to Placental Nutrient Transport and Maternal Food Intake

Start date: October 11, 2018
Phase: N/A
Study type: Interventional

Aims The primary aim is to examine the relation between maternal nutrition, placental transport of nutritional substances, and fetal blood flow distribution in normal pregnancies and in pregnancies complicated by altered fetal growth. Specific aims: 1. Examine the relation between fetal glucose, amino acid and lipid consumption, and ultrasound Doppler measures of fetal cerebral vascular resistance. 2. Examine the influence of extended fasting for two hours compared to a standard meal in a group with appropriate fetal group on fetal liver blood flow and fetal cerebral vascular resistance. The examinations will be performed at approximately 36 weeks gestation. 3. Examine the influence of a standard maternal meal on fetal liver blood flow and fetal cerebral vascular resistance in pregnancies complicated by fetal growth restriction (FGR). Study 1: Investigator will use the 130 fetal-maternal pairs from the "placental 4 vessel sampling method" (see below) which includes measures on fetal blood flow distribution. Some calculations will be performed on the restricted cohort of 70 pregnancies who also includes maternal blood flow measures. Study 2: A limitation of investigators previous studies on the influence of glucose intake or a regular maternal meal on fetal blood flow distribution in healthy pregnancies with appropriate fetal growth is the lack of a control group without food intake (extended fasting for two hours). To serve as participants own control the included participants will meet for examinations at two different days (one with food intake and one with extended fasting) within a few days interval. Participants will be examined in the morning and two hours after food intake or after two hours extended fasting. The study will include 25 pregnancies with gestational age about 36 weeks Study 3: Investigator will include approximately 55 women (see power calculation below) with pregnancies complicated by FGR defined as estimated birth weight (EFW) below the 3rd percentile and/or EFW below the 10th percentile and sign of fetal Doppler blood flow redistribution representing possible fetal compromise . Investigator hypothesize that there will be no reduction in fetal cerebral vascular resistance (measured as change in MCA-PI from before to after food intake). Fetal liver blood flow will also be measured. Methods The "Placental 4 vessel sampling method" This method has recently been developed by investigators research group and described in recent publications. In brief, blood samples are obtained from incoming (arterial) and outgoing (venous) vessels both at the maternal and fetal side of the placenta simultaneously during cesarean section. Samples have been taken from women with normal pregnancies but with a range of BMI and metabolic profiles: the physiological range group (undergoing cesarean delivery on own request). Investigators have a complete dataset including blood sampling and fetal blood flow measurements in the UV, DV and MCA-PI in 130 women. Further, investigators have maternal blood flow measures in 70 of these pregnancies. Doppler blood flow measurements Doppler blood flow measurements will be performed in the morning immediately before (fasting state) and after a standard breakfast meal (SBM) (approximately120 min). Internal vessel diameter (D) and time-averaged maximum velocity (TAMX) will be measured in the straight portion of the intra-abdominal UV and at the inlet of DV, respectively. In the MCA Doppler velocity waveforms are sampled from the proximal part emerging from the circle of Willis . MCA in the hemisphere near the transducer will be used unless there are better insonation properties in the opposite hemisphere. Umbilical artery Doppler traces will be sampled in a free-floating loop. The Doppler tracings will be used to measure fetal heart rate (FHR). All measurements will be performed during periods of fetal quiescence.

NCT ID: NCT04051567 Recruiting - Preterm Birth Clinical Trials

Low-dose Aspirin for Prevention of Adverse Pregnancy Outcomes in Twin Pregnancies

Start date: November 1, 2018
Phase: Phase 4
Study type: Interventional

Twin pregnancies are associated with increased risk of perinatal adverse outcomes , including preeclampsia , fetal growth restriction , preterm premature rupture of membranes and preterm birth. Low-dose aspirin was recommend by American College of Obstetricians and Gynecologists (ACOG) during pregnancy. In this trial, the investigators suppose that aspirin used in twin-pregnancies could improve adverse pregnancy outcomes.