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Premature Birth clinical trials

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NCT ID: NCT04110704 Recruiting - Preterm Birth Clinical Trials

Cerclage After Full Dilatation Caesarean Section

CRAFT
Start date: October 2, 2019
Phase: N/A
Study type: Interventional

CRAFT-OBS: Observational Study; To evaluate subsequent pregnancy risk of preterm birth in women with a history of previous caesarean in established labour. This prospective study using clinically acquired cervical length and quantitative fetal fibronectin data will help establish a predictive model of preterm birth <34 weeks and <37 weeks. CRAFT-RCT: Randomised controlled trial arm; To assess treatment for short cervix in women at high risk of preterm birth following a caesarean section at full dilatation CRAFT-IMG: Imaging sub-study; To aid understanding of micro and macrostructural features within the cervix which predisposes to preterm birth in women with a previous full dilatation caesarean section. This will use MRI and an advanced transvaginal ultrasound protocol and to assess if structural changes can be visualised in the cervix.

NCT ID: NCT04073836 Recruiting - Cerebral Palsy Clinical Trials

GMA and Peri in Moderate-late Preterms

Start date: January 1, 2019
Phase:
Study type: Observational [Patient Registry]

To analyze the relationship between the early diagnosis of cerebral palsy with the risk factors of this pathology in moderate and late premature infants

NCT ID: NCT04051567 Recruiting - Preterm Birth Clinical Trials

Low-dose Aspirin for Prevention of Adverse Pregnancy Outcomes in Twin Pregnancies

Start date: November 1, 2018
Phase: Phase 4
Study type: Interventional

Twin pregnancies are associated with increased risk of perinatal adverse outcomes , including preeclampsia , fetal growth restriction , preterm premature rupture of membranes and preterm birth. Low-dose aspirin was recommend by American College of Obstetricians and Gynecologists (ACOG) during pregnancy. In this trial, the investigators suppose that aspirin used in twin-pregnancies could improve adverse pregnancy outcomes.

NCT ID: NCT04047849 Recruiting - Preterm Birth Clinical Trials

Latency Antibiotics in Previable PPROM, 18 0/7- 22 6/7 WGA

Start date: August 28, 2019
Phase: Phase 4
Study type: Interventional

This study is a non-blinded, prospective, randomized controlled trial designed to compare the effect of outpatient oral antibiotics (i.e., amoxicillin and azithromycin) on the length of time (days) that pregnancy continues after a patient's water bag has ruptured prematurely. If a patient has been diagnosed with rupture of their water bag between 18 0/7 weeks and 22 6/7 weeks and there are no other associated complications with the pregnancy, the patient is eligible for initial consideration for this study. Patients will be admitted to the hospital for a 24-hour monitoring period. If the patient remains without further complications during this monitoring period, the patient will be eligible for enrollment. If enrollment is desired, the patient will be randomly assigned to receive either antibiotics (treatment arm of the study) or no antibiotics (control arm of the study). The treatment arm will receive an outpatient, 7-day course of oral antibiotics (azithromycin and amoxicillin) with the first dose given in the hospital to ensure no side effects. The control arm will not receive outpatient antibiotics. Both groups will have weekly, office follow-up visits with high-risk pregnancy specialists to ensure no further complications. Both groups will be admitted to the hospital if the patients reach 23 0/7 weeks without complications. At this time the patients will receive all medications and therapies recommended by the governing board of OBGYNs. Subjects of both groups will also be admitted before 23 0/7 weeks if further complications noted either at their clinic follow up visits or anytime outside of the hospital. The duration of time that the patient remains pregnant after breaking of the water bag will be compared in each group. The investigators will also see if there is a difference in the number of patients able to reach 23 0/7 weeks between each group (treatment versus control).

NCT ID: NCT04041635 Recruiting - Premature Clinical Trials

Reduction of Visual and Auditory Stimuli to Reduce Pain During Venipuncture in Premature Infants.

VENOPUNCIPREM
Start date: July 1, 2019
Phase: N/A
Study type: Interventional

The aim of the study is: To evaluate the efficacy of the reduction of visual and auditory stimuli on pain during venipuncture in premature newborns of 32-36 weeks of gestation.

NCT ID: NCT04037514 Recruiting - Clinical trials for Patent Ductus Arteriosus After Premature Birth

Paracetamol Versus Ibuprofen in Premature Infants With Hemodynamically Significant Patent Ductus Arteriosus

IBUPAR
Start date: July 7, 2017
Phase: Phase 3
Study type: Interventional

Multicentric, double-blind clinical trial, which will evaluate the efficacy of iv paracetamol versus standard treatment with ibuprofen in the closure of patent ductus arteriosus in the preterm newborn. Secondarily, we intend to compare the safety of both treatments, increase our knowledge about the pharmacokinetics, pharmacodynamics and pharmacogenetics of paracetamol and ibuprofen in the neonatal period and make a pharmacoeconomic assessment of the use of both drugs.

NCT ID: NCT04031456 Recruiting - Clinical trials for Premature Ovarian Failure

Autologous PRP Infusion May Restore Ovarian Function and May Promote Folliculogenesis in POI Patients

PRP
Start date: July 30, 2019
Phase: Phase 2/Phase 3
Study type: Interventional

Autologous PRP intra ovarian infusion may restore ovarian function, may promote folliculogenesis and may improve patients' hormonal profile in patients presenting with POI.

NCT ID: NCT04021485 Recruiting - Clinical trials for Premature Childbirth

BETAmethasone Dose Reduction: Non-Inferiority on the Neurocognitive Outcomes of Children Born Before 32 Weeks of Gestation

BETANINO
Start date: March 23, 2022
Phase: N/A
Study type: Interventional

Maternal antenatal corticosteroid therapy is the last major advance in the antenatal management of fetuses to prevent neonatal complications associated with prematurity. Long-term neurological outcomes in infants exposed to antenatal steroids have been assessed in few cohorts and suggest that this therapy is able to prevent some neurodevelopmental impairments including cerebral palsy. While >85% of neonates born very preterm in Europe have been exposed to antenatal betamethasone, Cochrane collaborative networks stated that trials of dosages comparing different regimens of commonly used corticosteroids are most urgently needed to avoid useless fetal exposure to excessive dosage of corticosteroids. - Because a half dosage was associated with maximal benefits on lung function in ewes, a randomized controlled trial (BETADOSE, NCT02897076) has been conducted to demonstrate that a 50% reduced betamethasone dose regimen is not inferior to a full dose to prevent respiratory distress syndrome in preterm neonates. BETADOSE trial demonstrated that half dose did not show noninferiority to full antenatal betamethasone dose regimen to prevent severe RDS in preterm neonates while other prematurity-associated complications, including those usually prevented by ACS, did not differ between the two groups. - Results of the 5-year BETANINO follow-up study of the BETADOSE neonates are needed before deciding whether reducing ACS dose is possible The main hypothesis of BETANINO is that half dose regimen of betamethasone is not inferior to full dose regimen of betamethasone to prevent neurodevelopmental impairments in these high-risk children born very preterm at 5 years of age.

NCT ID: NCT03992534 Recruiting - Preterm Birth Clinical Trials

The FLIP-1 Study: Vaginal Lactobacillus Supplementation in Women at High Risk of Preterm Birth

Start date: September 16, 2019
Phase: Phase 1
Study type: Interventional

Preterm birth (PTB) is the primary cause of infant death worldwide. It has been shown that a vaginal microbiota deplete in Lactobacillus species is a risk factor for preterm labour. Conversely a vaginal microbiota dominated by Lactobacillus crispatus appears to be protective for these adverse outcomes. A wide range of 'over the counter' Lactobacillus spp. containing products targeted at 'vaginal health' and formulated for vaginal administration are available, but most of them do not contain vaginal species of Lactobacillus. The primary aim of this study is to determine whether vaginal supplementation with L. crispatus CTV-05 is associated with colonisation.

NCT ID: NCT03990116 Recruiting - Premature Infant Clinical Trials

Efficacy of Lateral Kangaroo Care in Hemodynamic Stabilization of Premature Infant.

Cangulat
Start date: May 10, 2019
Phase: N/A
Study type: Interventional

The objetive of the study is to evaluate the non-inferiority or the equivalence of the kangaroo care position, in lateral versus traditional one in prone measuring the stability of several parameters in premature infants less than 28 weeks of gestational age during the first 5 days of life.