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Preterm Birth clinical trials

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NCT ID: NCT04644354 Not yet recruiting - Preterm Birth Clinical Trials

The Efficacy of Nifedipine in the Management of Preterm Labor

BOG/TH/PTL
Start date: December 15, 2020
Phase:
Study type: Observational

Preterm labor is one of the problems of obstetrics, and is one of the leading cause of neonatal morbidity and mortality. The incidence of preterm birth is around 7 to 9 %. The preterm baby is prone to respiratory, renal, neurologic and gastrointestinal problems. The correct diagnosis should be followed by the early administration of the most effective tocolytic agent with least side effects for both mother and fetus. Nifedipine, a calcium channel blocker, has gained a world-wide popularity recently since it has the least side-effects on both mother and fetus. In the present study, we aimed to evaluate the success rate of tocolytic agent 'nifedipine' on the spontaneous preterm labor of singeton pregnant women with intact amnionic membrane.

NCT ID: NCT04614714 Not yet recruiting - Preterm Birth Clinical Trials

Milk Volume Outcomes Following Oral Nicotinamide Riboside Supplementation in Mothers of Extremely Preterm Infants

MOONRISE
Start date: December 2024
Phase: Phase 2/Phase 3
Study type: Interventional

Breastfeeding has well-established immunity and developmental benefits for newborns, yet mothers of preterm infants often struggle to provide sufficient breast milk. The investigators hypothesize that supplementing mothers of preterm infants with nicotinamide riboside (NR) during early postpartum will result in increased milk production. NR is a unique precursor to NAD+, which functions in whole-body metabolism, including that which supports the elevated energy demands of lactation. In lactating rats, NR supplementation improved milk quantity and quality, with metabolic benefits for the mother and lasting protective advantages for the offspring. No studies have been conducted to date that explore the short- or long-term use of NR for increasing milk supply in lactating women. This study will follow a small cohort of women and very preterm infants in the NICU throughout two intervention phases-- one in which each mother will randomly receive either NR or a placebo, then the opposite treatment-- to determine the effect of maternal NR supplementation on expressed milk volume and other markers of metabolism.

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)

NCT ID: NCT03418311 Not yet recruiting - Preterm Birth Clinical Trials

Cervical Pessary Treatment for Prevention of s PTB in Twin Pregnancies on Children`s Long-Term Outcome

Impetus
Start date: September 2020
Phase: N/A
Study type: Interventional

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).

NCT ID: NCT03418012 Not yet recruiting - Preterm Birth Clinical Trials

Prevention of sPTB With Early Cervical Pessary Treatment in Women at High Risk for PTB

Prometheus
Start date: September 2020
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT02953795 Not yet recruiting - PreTerm Birth Clinical Trials

Supporting Mothers of Preterm Infants: A Randomized Controlled Trial

Start date: November 2016
Phase: N/A
Study type: Interventional

Preterm birth is the leading contributor to mortality among children younger than 5 years. One effective and inexpensive intervention is providing skin-to-skin care (STSC) whereby the mother of a preterm baby provides skin-to-skin contact to the newborn for at least a few hours, ideally every day. This intervention can make breastfeeding easier and can improve the health and development of the baby. Unfortunately, despite the large health benefits, mothers in low-resource communities are often unable to practice STSC due to a range of institutional and economic barriers. STSC requires substantial time and financial commitments from mothers; they must travel from home each day to the hospital to engage in STSC and provide expressed breast milk. Low-income women with access only to limited federally provided unpaid family leave may have to choose between returning to work while their baby is in the NICU and being able to stay at home with their newborn after discharge from the NICU. Families of preterm infants also face direct financial costs of practicing STSC and breastfeeding (such as fees for parking and childcare for older children). This trial aims to examine the impact of providing additional support to low-income mothers of babies born preterm in a hospital in Boston, Massachusetts to help them provide STSC. Half of the participants will be randomized to receive an additional financial support intervention while their infant is in the NICU. The study will examine how this intervention impacts mothers' health behavior while their child is in the NICU and up to three months after. Most of the current and past policy efforts to increase STSC have focused on the delivery of STSC at hospitals, focusing on supply-side related challenges such as the lack of trained and informed staff. However, interventions that focus exclusively on hospitals are unlikely to be sufficient for low-income women if there are significant opportunity costs or transportation costs to simply being present at the hospital. This study aims to provide more evidence to determine whether removing these financial barriers has the potential to mitigate the poor outcomes of preterm babies born to lower socioeconomic status households.

NCT ID: NCT02621996 Not yet recruiting - Preterm Birth Clinical Trials

Hammock Positioning's Influence on the Electromyographic Activity in the Flexor Muscles in Newborn Preterm

Start date: December 2015
Phase: N/A
Study type: Interventional

The individual who is born premature, in addition to a CNS still in accelerated training suffers early loss of intrauterine restraint, conditions that promote hypotonia characteristic of premature birth. Given this hypotonia associated with musculoskeletal immaturity when improperly positioned in the incubator for an extended period, the PN can develop joint contractures and postural imbalances that, in most cases, are transitory, however can become persistent, causing delay in their Motor development. The aim of this study is to analyze the influence of the positioning of preterm infants in the incubator hammock on the tone and the myoelectric activity of the rectus abdominis flexor muscles, biceps and hamstrings. Study type controlled, randomized, double-blind, to be carried out from November 2015 to April 2016 will be obtained two groups, control (in containment nest "U") and experimental (with hammock) to from randomized samples with premature births in Barao de Lucena Hospital or the Hospital das Clinicas, UFPE, the Intermediate Care Units (ICU) Neonatal. The sample will consist of 30 premature. To collect, pulse oximeter will be used, electromyography, neurological testing Dubowitz and recording behavioral responses. Each baby will be accompanied for about 8 hours daytime placement for two days and three evaluations performed.

NCT ID: NCT02470676 Not yet recruiting - Preterm Birth Clinical Trials

Cervical Pessary vs Vaginal Progesterone in Preventing Preterm Birth Among Women Presenting With Short Cervix: An Open-label Randomized Controlled Trial

Start date: July 2015
Phase: Phase 2/Phase 3
Study type: Interventional

The purpose of this randomized control trial is to determine whether cervical pessary plus vaginal progesterone is superior to vaginal progesterone alone in decreasing preterm delivery rate, and improving perinatal outcome, among women presenting with an asymptomatic mid-pregnancy short cervix, in singleton and twin gestations. All women with singleton or twin pregnancies undergoing routine ultrasonography up to 24 completed weeks of gestation (for examination of fetal anatomy and growth) and diagnosed with cervical length of ≤25 mm in singleton, or ≤38 mm in twins, will be invited to participate in the clinical trial. Women who meet eligible criteria will be invited to participate in the clinical trial. Women will be randomly assigned into one of the following groups: group A (vaginal progesterone) or group B (vaginal progesterone + pessary). Follow-up visits for ultrasound assessment of fetal growth and cervical length will be carried out every two weeks until 37 weeks of gestation.

NCT ID: NCT01152528 Not yet recruiting - Preterm Birth Clinical Trials

Va-Sense - Bacterial Vaginosis Once A Week Screening And Treatment To Reduce Infective Complications, Abortion And Preterm Delivery In Pregnant Women With Previous Preterm Delivery

Start date: July 2010
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine whether screening of pregnant women with history of previous preterm delivery, once a week, for bacterial vaginosis using VA-SENSE, and treatment of positive women will reduce the risk of spontaneous preterm birth. We will compare between the effectiveness of once a week screening and once during pregnancy screening.