Clinical Trials Logo

Premature Birth clinical trials

View clinical trials related to Premature Birth.

Filter by:

NCT ID: NCT03618836 Completed - Preterm Birth Clinical Trials

Study of the Risk of PREMaturité According to the Balance of Bacterial Flora VAginale

PREMEVA2
Start date: November 2011
Phase:
Study type: Observational

Objective To compare vaginal microbiota in the first trimester of pregnancy between spontaneous preterm and term deliveries

NCT ID: NCT03610841 Recruiting - Preterm Labor Clinical Trials

Evaluation of the Possible Relationship Between Periodontal Disease and Preterm Labor

Start date: February 17, 2018
Phase:
Study type: Observational

The primary objective of the study is to assess the incidence and severity of the periodontal infection of patients with preterm labor. The secondary objective of the study is to analyze the relationship between preterm labor and periodontal infection, using clinical, biochemical and microbiological methods.

NCT ID: NCT03608995 Recruiting - Preterm Labor Clinical Trials

Diagnostic Tests in the Context of Threatened Preterm Labour

PREMAQUICK
Start date: August 21, 2018
Phase: N/A
Study type: Interventional

The primary purpose of the protocol is to compare the diagnostic accuracy in terms of positive and negative predictive values of Premaquick © (combined detection of IL-6 / IGFBP-1 total / IGFBP-1 native) and Quikcheck fFN ™ (fibronectin detection) tests for prediction of spontaneous delivery within 7 days in women with threatened preterm labor. The study hypothesis is that combined detection of IL-6 / IGFBP-1 total / IGFBP-1 native dice the admission will improve the prediction of delivery compared to the detection of fetal fibronectin alone in women with threatened preterm labor.

NCT ID: NCT03602625 Completed - Risk Factors Clinical Trials

Risk Factors of Preterm Birth Born in Hospital:a Prospective Multicenter Case-control Study

RFPTB
Start date: January 1, 2018
Phase:
Study type: Observational

The purpose of this study is to explore the perinatal risk factors of preterm birth in China.

NCT ID: NCT03601195 Recruiting - Preterm Birth Clinical Trials

Prediction of Spontaneous Preterm Birth by Cervical Elastogram

Start date: July 3, 2017
Phase:
Study type: Observational

Background: Preterm birth is the leading cause of perinatal morbidity and mortality in multiple pregnancies. The medical and educational expenditure and lost productivity associated with preterm birth is very high. Sonoelastography is a new ultrasound technology which has enabled the measurement of tissue stiffness and it has been widely applied in assessment of breast lump and liver cirrhosis. Sonoelastography is potentially useful for the objective assessment of cervical consistency which could be related to risk of preterm birth. Objective: To assess the cervical consistency by shear wave elastography in prediction of preterm birth in multiple pregnancies. Setting: This is a prospective non-interventional observational study. Subjects: Chinese women carrying multiple pregnancies attending antenatal visit are invited to join the study. Method: Demographic data and antenatal history will be obtained. Transvaginal scan for the cervix will be performed by a trained researcher or obstetrician for the assessment of cervical consistency, cervical length, posterior cervical angle and fetal viability. The measurements will be repeated during 5 antenatal visits or separate study visits at 11-15, 16-19, 20-23, 24-27 and 28-32 weeks of gestation. At the end of pregnancy, the delivery data and neonatal outcome will be collected. Sample Size: The risk of preterm birth <34 weeks in twin pregnancies is approximately 20%. A sample size of 120 was determined as being sufficient to test the diagnostic performance of cervical elasticity in mid trimester assuming that the risk of preterm delivery <34 weeks vs >34 weeks is 1:5 and that cervical elasticity area under curve (AUC) of the receiver operating characteristics (ROC) curve was 0.7, with 80% power and alpha of 5%. Data Analysis: Changes in the cervical elastography will be compared using the Student paired two-tailed t test, and in the case of unequal standard deviation (SD), using a Wilcoxon signed-rank paired two-tailed test. For comparison of frequencies, Chi-square test, or a two-sided Fisher exact test will be used where appropriate. Linear regression will be used to assess the correlations. The level of statistical significance is set at p<0.05 (two-sided).

NCT ID: NCT03599167 Completed - Clinical trials for Practice Guideline of Erythrocyte Transfusion in Preterm Infant

Red Blood Cell Transfusion in Very Premature Infants and HAS 2014 Guideline

RBCPREM
Start date: January 22, 2018
Phase:
Study type: Observational

The indications that motivated the decision to transfuse (or not) were analyzed to verify compliance with HAS recommendations. Medical records from 57 premature infants < 32 weeks hospitalized between 2016 -2017 were retrospectively analysed, especially all the events related to monitoring of hemoglobin level and RBC transfusions during the first month of life. The criteria (postnatal age, rate of haemoglobin, type of breathing assistance, oxygen needing, medullary regeneration) on which rely the decision process in the HAS algorithm for the RBC transfusion were also considered, as well as the final decision actually adopted for each case (transfused/ not transfused). All this made it possible to determine the kappa coefficient for evaluation of agreement with HAS new guidelines in the investigator's medical staff.

NCT ID: NCT03596125 Terminated - Preterm Delivery Clinical Trials

Correction of Neonatal Glutathione by N-acetylcysteine in Pregnant Women at Risk of Premature Birth (GSH MAP)

Start date: November 5, 2018
Phase: Phase 2/Phase 3
Study type: Interventional

Birth exposes the newborn to oxidative stress, as due to the switch from a protected, relatively hypoxic intrauterine milieu into an environment with a high oxygen pressure. The full-term newborn is well prepared to this massive redox challenge at the time of birth due to his well-integrated antioxidant defenses. On the contrary, numerous bibliographical data and our own work demonstrate the fragility of preterm newborns in this context of oxidative stress, linked to the immaturity of his antioxidant defenses. Premature birth abruptly propels the fetus from the protected, relatively hypoxic intrauterine milieu to an environment at risk of free radical injury caused by mechanical ventilation strategies, including the use of high inspired oxygen fractions or inhaled nitric oxide, generating excessive reactive oxidative species (ROS). Several studies highlight the key role of ROS in adverse outcomes of preterm infant suffering from low birth weight, bronchopulmonary dysplasia, necrotizing enterocolitis or retinopathy. This project aims to evaluate a therapeutic anti-oxidative strategy in order to correct the oxidative status of preterm infants. The investigators propose an early intervention that consists in an antenatal maternal supplementation with N-acetylcysteine (NAC), the acetylated precursor of both cysteine and glutathione, a key physiological antioxidant. This strategy could be promising for the development of simplified and personalized care of preterm infants. GSH MAP is a randomized, single-blind, placebo-controlled study that aims to determine if NAC supplementation in women admitted to hospital care due to preterm labor (prior to 34 weeks of gestational age) may correct glutathione deficiency in neonatal cord blood.

NCT ID: NCT03592134 Recruiting - Clinical trials for Respiratory Distress Syndrome

Optimal Settings of Non Invasive Respiratory Support in Preterm Newborns

Start date: February 22, 2018
Phase:
Study type: Observational

Noninvasive respiratory supports (NRS), such as continuous positive airway pressure (CPAP), noninvasive ventilation, high flow nasal cannula (HFNC) or nasal oxygen (O2), are commonly used in preterm newborns hospitalized in neonatal intensive care unit. However, given the lack of validated criteria, clinicians usually choose the NRS according to clinical parameters and patients' comfort. Several studies have demonstrated the interest of the measurement of the work of breathing (WOB) to optimize the settings of NRS in children, but no study has already demonstrated the utility of WOB to optimize the settings of NRS in preterm infants. Therefore, the aim of this study is to measure the WOB during the utilisation of three different NRS (CPAP, HFNC, O2), in order to optimize the choice of the type and settings of NRS in a randomized group of 30 newborns born prematurely before 30 gestational weeks and still requiring NRS at 29 post conceptual weeks. Moreover, the investigators will compare in the newborns with the optimized NRS by WOB vs. a standard care control group (NRS type and settings determined as clinical routine): 1) the respiratory morbidity and mortality one month after the initial assessment, and at the time of hospital discharge (or transfer) or at 36 weeks of age corrected (whatever comes first), 2) the weaning time of the NRS, 3) the incidence and severity of broncho-pulmonary dysplasia (BPD) at 36 weeks of age corrected. Indeed, incidence of BPD is still around 40% in premature infants born before 28 gestational weeks. The hypothesis of the investigators' study is that the optimization of the type and settings of the NRS could reduce the weaning delay and contribute to reduce the incidence and severity of BPD in premature newborns.

NCT ID: NCT03591042 Recruiting - Preterm Birth Clinical Trials

Universal Transvaginal Cervical Length Screening Program for Prevention of Preterm Birth in Singletons Without Prior Preterm Birth

Start date: July 21, 2018
Phase: N/A
Study type: Interventional

This is a non-blinded randomized screening trial of asymptomatic singleton pregnancies without prior spontaneous preterm birth who are randomized to either transvaginal ultrasound cervical length screening program (i.e. intervention group) or no screening (i.e. control group). Women are consented and randomized at the time of their routine anatomy scan between 18 0/7 and 23 6/7 weeks. Women randomized in the transvaginal ultrasound cervical length screening will receive a single transvaginal ultrasound cervical length measurement after the anatomy scan. The cervical length will be measured by operators with certification of competence in the technique.

NCT ID: NCT03589365 Not yet recruiting - Preterm Birth Clinical Trials

Preterm Birth and Long Term Consequences on Myocardial Functions and Structure

PREMACOEUR
Start date: July 2018
Phase: N/A
Study type: Interventional

Cardiovascular diseases (hypertension, coronary heart disease, stroke and cardiac insufficiency) are the leading cause of death worldwide. They are a major cause of concern in public health worldwide as well. Their incidence is increasing especially in emerging countries. It has been shown through epidemiological and experimental studies that these cardiovascular diseases are influenced by environmental factors which can act early during different periods of the development. Preterm birth is an emerging risk factor of cardiovascular diseases. Preterm birth rate varies accordingly to countries from 6 % to 14 % and accounts for 80% of low birth weight. These past thirty years have shown an improvement in the management and survival rate of these babies. The number of preterm infants reaching adulthood is thus increasing. Long term effects of preterm birth on cardiovascular diseases are little known. However, emerging evidence suggest that preterm birth affects certain functions and structure. A significant increase in blood pressure and alterations on the vascular, metabolic, and renal systems have been reported in healthy young adult born preterm. And abnormal heart shape with left ventricular hypertrophy have been demonstrated in these population (Oxford)