View clinical trials related to Premature Birth.
Filter by:Pregnant African American women between 18 and 45 years of age will be enrolled at 20 weeks of gestation or less. Biological specimens (vaginal swabs, rectal swab) will be collected at enrollment, 23-24 weeks, at 28-29 weeks, and at the onset of labor. A urine sample will be obtained at entry and at the time of delivery for metabolomic analysis. Participants will also collect a dietary survey at entry, 23-24 weeks, and 28-29 weeks. The biological specimens will then be analyzed for their microbiomial profile. This will then be correlated with the timing of their delivery as well as other comorbidities such as obesity, hypertension, and diabetes.
Background (brief): 1. Burden: Bangladesh has a high maternal (194 per 100,000 live births) and newborn mortality (28 per 1000 live births). In 2010, prematurity represented ~14% of all births and directly and indirectly contributed to 45% of all neonatal deaths. Gestational age (GA) is a key determinant of newborn survival and long-term impairment. Accurate estimation of GA facilitates timely provision of essential interventions to improve maternal and newborn outcomes. 2. Knowledge gap: Last menstrual period (LMP) is a simple, low-cost self reported information, recommended by the World Health Organization for estimating gestational age but has issues of recall mainly among poorer, less educated women and women with irregular menstruation, undiagnosed abortion, and spotting during early pregnancy. Several studies have noted that about 20-50% of women cannot accurately recall the date of LMP. 3. Relevance: The goal of this study is to improve maternal and newborn outcomes by increasing the accuracy of gestational age estimation, using menstrual based dating, that is vital for providing timely and necessary obstetric and newborn care interventions. The study will determine the efficacy of three community based interventions using e-platform targeted to improve the recall and reporting of the date of last menstrual period in a rural resource poor setting. The innovative e-platform based interventions, if successful, can provide substantial evidence to scale-up in a low resource setting where e-Health and m-Health initiatives are proliferating with active support from all sectors in policy and implementation. Hypothesis : 1. Implementation of conventional and e-platform based interventions will lead to a 30% improvement in recall of the date of the LMP in adolescent girls and married women in rural Bangladesh. 2. Intervention triggered improvement in LMP date recall among pregnant women in rural Bangladesh will improve the accuracy in GA estimation. Objectives: The main objectives of the study are to: 1. Determine whether a set of conventional and e-platform based interventions improve recall of the date of the LMP in adolescent girls and married women in rural Bangladesh. 2. Determine whether intervention triggered improvement in LMP date recall in rural Bangladesh improves the accuracy in GA estimation or not Methods: A 4- parallel arm, superiority, community based cluster randomized controlled trial comparing three conventional and e-platform based interventions is proposed to improve recall of GA with a control arm. The trial will be conducted among adolescent girls and recently married women (within past two years) with no children or a single child in Mirzapur sub-district of Bangladesh.The interventions include (i) education and calendar for recording date of LMP (ii) education and SMS based system for recording dates of LMP and reminders using mobile phone (normal) (iii) education and smart-phone based application for recording dates of LMP with an inbuilt reminder system. Outcome measures/variables: The trial has two primary outcomes, (i) improvement in the recall of LMP date among enrolled participants in the three different intervention compared to control arm and (ii) increased accuracy of LMP-based gestational age measurement, as compared to USG, following the intervention.
Preterm newborns are born with lower vitamin D stores. Although vitamin D supplementation is recommended there is no consensus regarding the adequate dose of supplementation for preterm infants.
The purpose of this study is to determine if a repeat course of betamethasone given to pregnant women with preterm premature rupture of membranes (PPROM) will decrease the infant's length of stay in the neonatal intensive care unit (NICU) and the overall neonatal morbidity associated with this condition.
The purpose of this study is to evaluate the efficacy and safety of Dapoxetine/Sildenafil 30/50 mg film-coated tablet in the treatment of men with premature ejaculation and erectile dysfunction.
The aims of this study are: 1. To assess the prevalence of prematurity, especially early prematurity, among T1D patients, and compare it to the prematurity prevalence among the non-diabetic general population in Israel. 2. To characterize epidemiological and clinical factors that differ between premature-born patients that developed T1D and those that have not, including the nutritional and therapeutic properties in NICU.
Preterm birth (PTB) is a major cause of perinatal morbidity and mortality. Worldwide, about 15 million babies are born too soon every year, causing 1.1 million deaths, as well as short- and long-term disability in countless survivors. Few prognostic tests are available to predict PTB. A short transvaginal ultrasound cervical length (TVU CL) has been shown to be a good predictor of PTB.Different strategies have been adopted for prevention of PTB. The evidence supports the use of vaginal progesterone in singleton pregnancies with short cervix, while cervical cerclage seems to be beneficial only in the subgroup of singleton gestations with both prior spontaneous PTB and TVU CL ≤25mm, and not in singletons without prior PTB, nor in multiple gestations. However, so far there are no level-1 data on the efficacy of TVU CL screening neither in low risk nor in high risk pregnancy Thus, we aim to assess the efficacy of a policy of TVU CL screening in singleton pregnancy without prior spontaneous PTB
For therapy of symptomatic premature ventricular complexes (PVCs) in subjects with structural heart disease the current European Guidelines for the management of patients with ventricular arrhythmias and the prevention of second cardiac death recommend catheter ablation as well as amiodarone with a class IIa indication. Due to the lack of randomized data this study investigates the comparison of catheter ablation and amiodarone for PVC treatment in patients with structural heart disease. Therefore, patients will be randomized to one of two treatment strategies: 1) catheter ablation, or 2) amiodarone.
Preterm birth (PTB) is the major cause of perinatal morbidity and mortality. Worldwide, about 15 million babies are born too soon every year, causing 1.1 million deaths, as well as short- and long-term disability in countless survivors. Few prognostic tests are available to predict PTB. A short transvaginal ultrasound cervical length (TVU CL) has been shown to be a good predictor of PTB.Different strategies have been adopted for prevention of PTB. The evidence supports the use of vaginal progesterone in singleton pregnancies with short cervix, while cervical cerclage seems to be beneficial only in the subgroup of singleton gestations with both prior spontaneous PTB and TVU CL ≤25mm, and not in singletons without prior PTB, nor in multiple gestations. However, so far there are no level-1 data on the efficacy of TVU CL screening neither in low risk nor in high risk pregnancy Thus, the investigators aim to assess the efficacy of a policy of TVU CL screening in singleton pregnancy with prior spontaneous PTB
Obstructive lung disease is an increasing global health problem of pandemic proportions, with COPD alone affecting >10% of the population. Smoking is the main and most well studies risk factor for developing COPD. However, chronic airway obstruction also in never-smoking populations has recently been recognized as an increasing health problem. Prematurely born children, particularly survivors of bronchopulmonary dysplasia (BPD), defined as the need for oxygen therapy up to the 28th day of life for children born prior to gestational week 32, have an increased incidence of both airway obstruction and hyper-reactivity, both representing major risk factors for developing COPD, or asthma, later in life. The purpose of this study is to perform in-depth clinical and molecular characterizations of of the lungs of survivors of BPD as they enter adulthood, and compare these profiles to relevant control groups (individuals with mild asthma, healthy prematurely born, and healthy individuals born at full term). Specifically, alterations at the epigenetic, mRNA, microRNA, protein and metabolite level as well as associated molecular pathways critical in the pathological mechanisms of obstructive lung disease related to premature birth and BPD will be identified.