View clinical trials related to Preterm Birth.
Filter by:Preterm birth (PTB) is a major challenge to perinatal health. It is defined as delivery before 37 completed gestational weeks. It accounts for 75% of perinatal deaths and more than 50% of long-term neurological disabilities, and it is the second most common cause of death in children under the age of 5 year. Neonates born preterm are at risk of respiratory distress syndrome, chronic lung disease, retinopathy of prematurity, necrotizing enterocolitis, intraventricular haemorrhage and sepsis in the short term, as well as cerebral palsy, motor and sensory impairment, learning difficulties, and increased risk of chronic disease in long run. It is estimated that the societal cost of PTB is $26 billion annually in the USA alone. Until now, prevention or reduction of PTB is based on identification of risk factors in obstetrical history, biochemical markers and short cervix. History of PTB and asymptomatic short cervix at the second trimester are both strong predictors for PTB. In women with asymptomatic short cervix at the second trimester, vaginal progesterone could effectively reduce PTB. Universal cervical length screening followed by treatment with vaginal progesterone has been shown to be the most cost effective strategy in preventing PTB. These findings were confirmed in meta-analysis. Nevertheless, only minority of women may benefit from progesterone treatment if it was being started at the second trimester. There is still a large proportion of PTB, which is currently not preventable, and the current approach to prevent PTB is far from ideal. One possible hypothesis is that the initiation of progesterone treatment would be too late for its effect to take place. Therefore, we decide to use oral progesterone in the current study. The objective of the study is to determine whether early use of progesterone can prevent PTB better when compared with universal screening of cervical length and followed by treatment with progesterone in those with short cervix.
Preterm birth (PTB) complicates 13% of all pregnancies worldwide and is the most important cause of neonatal morbidity and mortality. Women with a twin pregnancy are at increased risk of preterm delivery. In the Netherlands, approximately 50% of women with a multiple pregnancy deliver before 37 weeks of gestation (WoG), of whom 9% deliver before 32 weeks. Evidence based treatment guidelines concerning prevention of PTB are not available in Europe. Expectant management is usual care with interventions only in terms of a tertiary prevention of PTB according to guidelines for premature rupture of membranes, premature labour or other pregnancy complications. The studies done on this topic included women at different stages of the second trimester so the question of the onset of cervix shortening and its impact on PTB is not answered yet. The critical period for a maximum impact of the pessary treatment on PTB is still to be verified. Up to now only the ProTwinTrial addressed the long-term outcome of the newborns, so here data and evidence is clearly missing. The investigators want to assess the impact of a cervical pessary treatment in twin pregnancies with cervical shortening on children's survival without neurodevelopmental disability at the age of 3 years at 3 different stages of the second trimester (16-20 (early) vs. 20-24 (middle) vs. 24-28 (late) weeks of gestation).
Prevention of preterm birth (PTB) is a key factor for a positive short-term and long-term outcome of the newborn children as mortality and morbidity are inversely related to gestational age at delivery. Consequently every week of prolonged pregnancy will have a tremendous effect concerning the outcome of the new-borns, subsequently for their parents and society as well. The proposed RCT aims to evaluate the impact of a preventive pessary treatment on the prevention of preterm birth in women with a singleton pregnancy who are at high risk of spontaneous preterm birth (sPTB) due to a history of at least one previous preterm delivery and/or a history of previous cervical surgery. In accordance with the results by "van´t Hooft et al. 2016" an approximately 20% higher percentage of children's long-term survival without neurodevelopmental disability is expected for the pessary group in comparison with usual management (=control group) on basis of a reduction of prematurity < 34 week of gestation (WoG). The primary outcome measure for the effect of the pessary treatment in comparison to expectant management will be the children's long-term survival (3yrs) without neurodevelopmental disability. Secondary endpoints assess the impact of a preventive pessary placement on the prevention of preterm birth and its resulting risk on mortality and morbidity for the neonates.
Preterm labor is the first cause of hospitalization during the pregnancy, and at the origin of more than 60 000 births before 37 weeks of amenorrhea every year in France. It is however difficult to predict if a patient consulting in emergencies with symptoms of preterm labor, will give birth prematurely or not. Current diagnostic tools to identify patients with high risk of premature delivery in 7 days are insufficient because of their low positive predictive value. Yet the neonatal complications in case of premature delivery are important, with respiratory distress syndrome, hyaline membrane disease, necrotizing enterocolitis, intraventricular hemorrhage and post-natal death. Recent studies suggested that the detection of the placental alpha microglobulin 1 (PAMG-1) in the vaginal secretions, by Partosure® test at the women presenting symptoms of preterm labor with intact membranes would indicate that a premature spontaneous delivery could arise in 7 days with a good positive predictive value.The test is interesting all the more as the repetition of the prenatal cures of corticosteroids, aiming at the fetal lung maturation, is this day more recommended and as the beneficial effect takes place within 24 hours in 7 days following their administration. It seems thus essential to make studies to specify the interest of this test at the patients presenting a preterm labor. This study aims at estimating the diagnostic performance of the test of detection of PAMG-1 in the prediction of a delivery in 7 days, at the patients presenting symptoms of preterm labor.
This study aims to understand parents' needs regarding social difficulties faced in a child's preterm birth context.
The M-O-M-S project evaluates the effectiveness of the M-O-M-S program for improving birth outcomes and maternal-infant attachment and role satisfaction in a large military sample.
This study evaluates the effects of the Nurse Family Partnership (NFP), an established home-visiting program, using a scientifically rigorous individual-level randomized controlled trial. The study will be based in South Carolina, where a Medicaid waiver in combination with a pay-for-success contract will allow expansion of the program to women on Medicaid. The study plans to enroll 4000 low-income, first time mothers and their children into the intervention group, and another 2000 into the control group. The study will evaluate the program's impacts on outcomes using administrative records. This study aims to yield new evidence on the effect of NFP in a modern context, applied to a new population, across a broad range of outcomes, and financed by a novel public-private partnership based on accountability for outcomes.
The aim of this novel health services research proposal is to assess the longer-term outcomes, to 6 months corrected age, of an adapted Family Integrated Care (FICare) model of care for moderate and late preterm infants admitted to a Level II neonatal intensive care unit (NICU). This follow-up study will enroll infants at 6 months CA (± 1 month) recruited to the original FICare randomized controlled trial (clinicaltrials.gov ID: NCT02879799) from four level II NICU sites; two intervention and two control.
This is a multicenter randomized study designed to determine if ultrasound indicated cerclage reduces the incidence of spontaneous preterm birth <34 weeks in asymptomatic women with twin gestations and cervical length ≤15mm, diagnosed by transvaginal ultrasound between 16 to 23 6/7 weeks of gestation.
Almost half of all deliveries in the United States are of nulliparous patients. They have been identified as an at-risk population for preterm birth. Historically, the most significant risk factor for preterm birth is a prior history of preterm birth, which cannot be applied to a nulliparous population. Forecasting adverse outcomes in first time moms is difficult to predict and prevent. Historically, physicians have prescribed a restriction in activity level for those at risk for preterm delivery. The utility of this intervention has yet to be prospectively and quantitatively studied. The Fitbit activity tracker is a wearable device that has been extensively used in medical research, in an attempt to quantitatively identify how patient activity levels can improve medical outcomes. The study uses the Fitbit device in nulliparous patients, remotely track their activity levels throughout pregnancy, and assess pregnancy outcomes. Because of the significant and long-standing health disparity in the incidence of preterm delivery, the investigators will use the "Everyday Discrimination Scale", a validated battery of racism and health to see how a patient's stress related to perceived discrimination may modify the risk of preterm delivery.