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Intrauterine Growth Restriction clinical trials

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NCT ID: NCT05253781 Active, not recruiting - Sickle Cell Disease Clinical Trials

Low Dose Aspirin for Preventing Intrauterine Growth Restriction and Preeclampsia in Sickle Cell Pregnancy (PIPSICKLE)

PIPSICKLE
Start date: July 1, 2020
Phase: Phase 3
Study type: Interventional

Pregnancy in sickle cell disease (SCD) is fraught with many complications including preeclampsia (PE) and intrauterine growth restriction (IUGR). Previously, the investigators found an abnormality in prostacyclin-thromboxane ratio in sickle cell pregnant women, a situation that is also found in non-sickle pregnancies with PE and unexplained IUGR. Low dose aspirin (LDA) has been found to reduce the incidence of PE and IUGR in high-risk women due to its reduction of vasoconstrictor thromboxane whilst sparing prostacyclin, in effect "correcting" the ratio. It has been found to be safe for use in pregnancy and is recommended in obstetric guidelines for this use but has not been tested in sickle cell pregnancy. The investigators hypothesize that LDA would reduce the incidence of IUGR and PE in pregnant haemoglobin (Hb)SS women. The investigators also plan to build a machine-learning model to predict severe maternal outcomes in them. The investigators propose a multi-site, randomized, controlled, double blind trial comparing a daily dose of 100mg aspirin with placebo, from 12 - 28 weeks gestation until 36 weeks. The study sites are three teaching hospitals in Lagos and Ile-Ife, and twelve general hospitals and one federal medical centre within Lagos state, with the coordinating centre at the College of Medicine, University of Lagos (CMUL), Idi-Araba, Lagos. A total of 476 eligible pregnant HbSS and HbSC women will be recruited consecutively and randomly assigned to either group using a web-based app, sealed envelope. Each study group will comprise 238 pregnant women with SCD. All participants will be followed from recruitment till delivery. They will have their body weight, blood pressure and haematocrit checked at each antenatal visit. Their full blood count, vital signs and oxygen saturation will be checked and recorded at each visit. Primary outcome measure will be birth weight below 10th centile for gestational age on INTERGROWTH 21 birthweight charts, and incidence of miscarriage or perinatal death. Analysis will be by intention to treat, and the main treatment effects will be quantified by relative risk with 95% confidence intervals, at a 5% significance level. The investigators plan to develop a prediction model to predict the risk of complications in these women using machine learning. The prediction outcome will be severe maternal outcomes comprising maternal near miss or death.

NCT ID: NCT05242107 Completed - Clinical trials for Intrauterine Growth Restriction

Omega-3 on Lipid Profile and Serum Leptin Level n Neonates With Intrauterine Growth Restriction

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

The aim of our study will demonstrate the effect of omega 3 supplementation on serum lipid profile level and leptin level in neonates with Intrauterine Growth Restriction( IUGR)

NCT ID: NCT05151289 Recruiting - Clinical trials for Intrauterine Growth Restriction

Diagnostic Value of sFlt-1/PlGF Ratio for the Etiology of Intra Uterine Growth Restriction - ANGIOPAG

ANGIOPAG
Start date: January 8, 2020
Phase: N/A
Study type: Interventional

The main aim of this project is to determine the Placental Growth Factor and Vascular Endothelial Growth Factor ratio's performance (sFlt-1/PlGF) for the etiological diagnosis of vascular Intrauterine growth restriction (IUGR) compared to a non-vascular IUGR.

NCT ID: NCT05142644 Completed - Clinical trials for Intrauterine Growth Restriction

IUGR; Cause and Relationship

Start date: January 1, 2020
Phase:
Study type: Observational

Intrauterine growth restriction (IUGR) is a pregnancy complication in about 3-5% of all pregnancies in Sweden. IUGR fetuses are at high risk of morbidity and death. The method used in Sweden to detect IUGR is repeated measurements of pregnant women's symphysis-fundus measure (SF measure). Weight estimation with ultrasound is performed only on indication; stagnant or deplaning SF dimensions or in the event of complications. Only high-risk pregnancies have repeated growth checks during pregnancy from the beginning. There are potential benefits to detecting IUGR fetuses during pregnancy. Still, the effect is questioned. A meta-analysis of randomized studies could not benefit from a routine ultrasound in the third trimester. The scientific purpose of this work is to evaluate the benefits of early detection and care of SGA (small for gestational age)/IUGR (growth-inhibited) fetuses and, if possible, to increase knowledge about this patient group. The hope is that this will lead to a better opportunity to personalize both preventive care and treatment of these women and children.

NCT ID: NCT05038462 Recruiting - Clinical trials for Fetal Growth Retardation

Fetal Brain Care: Therapies for Brain Neurodevelopment in Fetal Growth Restriction

Start date: January 18, 2023
Phase: N/A
Study type: Interventional

Singleton pregnancies being diagnosed of fetal growth restriction from 24 to 32.6 weeks of gestation will be randomized to two equally sized groups: maternal oral supplementation with Lactoferrin and DHA (Docosahexaenoic acid) or placebo.

NCT ID: NCT04907578 Withdrawn - Clinical trials for Intrauterine Growth Restriction

Thromboelastography (TEG) In the Intrauterine Growth Restriction (IUGR) Neonatal Population by Gestational Age

Start date: August 12, 2021
Phase:
Study type: Observational

The investigators aim to improve the understanding of TEG in this population in an effort to improve outcomes in a population at high risk in both the presence and absence of blood product transfusions.

NCT ID: NCT04849494 Completed - Preterm Birth Clinical Trials

Respiratory Morbidity of Late-Preterm Vs Intrauterine Growth Retarded Infants at School Age

Start date: January 1, 2011
Phase:
Study type: Observational

Background: It is increasingly recognized that late preterm infants have increased respiratory morbidity in the neonatal period as well as decreased lung function in later life. Also, in-utero growth retardation (IUGR) and low birth weight are associated with increased respiratory morbidity beginning from infancy, throughout childhood and into adulthood. However, very few studies have assessed long term respiratory consequences of late preterm birth in comparison with IUGR. Aim: To determine respiratory morbidity of late-preterm vs infants with IUGR at school age Study Design: Participants included late-preterm AGA infants (34-36, 6/7 weeks), IUGR infants (term/preterm) and term AGA infants born between 2004 and 2008 were included in this study and assessed for respiratory morbidity at school age. To assess the impact of late-preterm birth compared with IUGR and term gestation on respiratory morbidity by using a validated questionnaire. Wheezing, infectious respiratory morbidity and physician-diagnosed asthma panels were evaluated.

NCT ID: NCT04766866 Recruiting - Preeclampsia Clinical Trials

sFlt1/PlGF and Planned Delivery to Prevent Preeclampsia at Term.

PE37
Start date: March 2, 2021
Phase: N/A
Study type: Interventional

- Preeclampsia (PE) affects ~5% of pregnancies. Although improved obstetrical care has significantly diminished associated maternal mortality, PE remains a leading cause of maternal morbidity and mortality in the world. - Term PE accounts for 70% of all PE and a large proportion of maternal-fetal morbidity related with this condition. Prediction and prevention of term PE remains unsolved. - Previously proposed approaches are based on combined screening and/or prophylactic drugs, but these policies are unlikely to be implementable in many world settings. - Recent evidence shows that sFlt1-PlGF ratio at 35-37w predicts term PE with 80% detection rate. - Likewise, recent studies demonstrate that induction of labor (IOL) from 37w is safe. - The investigators hypothesize that a single-step universal screening for term PE based on sFlt1/PlGF ratio at 35-37w followed by IOL from 37w would reduce the prevalence of term PE without increasing cesarean section rates or adverse neonatal outcomes. - The investigators propose a randomized clinical trial to evaluate the impact of a screening of term PE with sFlt-1/PlGF ratio in asymptomatic nulliparous women at 35-37w. Women will be assigned to revealed (sFlt-1/PlGF known to clinicians) versus concealed (unknown) arms. A cutoff of >90th centile will be used to define high risk of PE and offer IOL from 37w. - If successful, the results of this trial will provide evidence to support a simple universal screening strategy reducing the prevalence of term PE, which could be applicable in most healthcare settings and have enormous implications on perinatal outcomes and public health policies worldwide.

NCT ID: NCT04633551 Completed - Pre-Eclampsia Clinical Trials

Vascular Inflammation and Anti-inflammatory Supplements After Adverse Pregnancy Outcomes

VIA
Start date: October 1, 2020
Phase: N/A
Study type: Interventional

Women who had an adverse pregnancy outcome (APO), such as preeclampsia, preterm birth, or gestational diabetes, have a higher risk for heart disease. Some of the extra risk for heart disease after APOs is thought to be caused by inflammation. Investigators will randomize women who had an APO in the past 3 years to receive an anti-inflammatory supplement or serve as a time control. Investigators will compare blood pressure, arterial stiffness, blood vessel reactivity, and blood markers of inflammation between women who did and did not receive the supplement. Investigators will determine women's attitudes about taking a dietary supplement and measure whether the participants who receive the supplement take all or most of the doses.

NCT ID: NCT04557475 Withdrawn - Clinical trials for Fetal Growth Retardation

Transplacental Aspirin Therapy for Early Onset Fetal Growth Restriction

Start date: June 11, 2022
Phase: Phase 3
Study type: Interventional

The purpose of this investigation is to evaluate the ability of maternal aspirin (ASA) therapy to prevent preterm birth for fetal indications prior to 32 weeks gestation in women with early onset Fetal Growth Restriction (FGR). Aspirin is a commonly used medication that blocks blood platelets from clumping. Aspirin crosses the placenta in a dose dependent mode. There is preliminary evidence in smaller studies that aspirin can block fetal platelet clumping and, therefore, slow down the progression of placental disease under specific circumstances. The optimal time for aspirin to work is when the fetus' placental dysfunction is still mild. The goal of this research study is to show if fetuses that receive aspirin through maternal intake at a dose shown to affect fetal platelet aggregation will be less likely to deliver before 32 weeks for fetal deterioration. The outcomes of patients that receive aspirin will be compared to women that receive standard FGR management but do not take any aspirin. The decision if a study participant receives aspirin or not will be randomly picked. Such a research study is called a randomized controlled trial.