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Preterm Labor clinical trials

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NCT ID: NCT04417595 Recruiting - Clinical trials for Tobacco Use Disorder

Investigating N-3 Fatty Acids to Prevent Neonatal Tobacco-related outcomeS

INFANTS
Start date: November 10, 2020
Phase: Phase 2
Study type: Interventional

Smoking is the most important modifiable risk factor for adverse pregnancy outcomes including preterm birth, neonatal death, and maternal complications. Rates of smoking cessation during pregnancy are low, particularly in underserved populations, and currently approved pharmacotherapies for smoking cessation either are considered unsafe in pregnancy or have uncertain effectiveness. Identifying safe and effective interventions, which might mitigate the adverse effects of smoking on maternal-fetal outcomes, is a major public health priority. We hypothesize that smoking-induced n-3 LCPUFA relative deficiencies may be an important mechanism contributing to tobacco-related adverse pregnancy outcomes and that n-3 LCPUFA supplementation specifically targeted to pregnant smokers may reduce these complications. Support for this hypothesis comes from a recent secondary analysis of the Omega-3 Fatty Acids Supplementation to Prevent Preterm Birth trial that found that only smokers taking n-3 LCPUFAs had a reduction in preterm labor risk as compared to non-smokers. While compelling, this study was a post hoc analysis that included only a small sample of smokers and did not collect data on smoking behaviors during follow up. Yet the ascertainment of longitudinal smoking behavior is critical, as some clinical studies have found that supplemental n-3 LCPUFAs might also reduce nicotine cravings, and lower daily cigarette use. Thus, smokers may doubly benefit from replenishing n-3 LCPUFAs via lower risk of preterm labor and/or increased smoking cessation. To address these knowledge gaps, we are proposing a multi-center, randomized, placebo-controlled, double-blinded study of n-3 LCPUFA supplementation in 400 pregnant smokers. We will collect detailed information on smoking behavior, validated biological markers of cigarette exposure (urinary cotinine, end-expiratory carbon monoxide) and biomarkers of n-3 LCPUFA status (red blood cell phospholipid membrane fatty acids). Our specific aims of this proposal are to 1) determine the effect of supplemental n-3 LCPUFAs on gestational age at delivery and preterm labor in pregnant smokers and 2) determine the effect of n-3 LCPUFA supplementation on tobacco use in pregnant smokers. We will recruit potential participants from eight obstetrics clinics across the Middle-Tennessee area. Our study could have a major translational impact on both adverse tobacco-related birth outcomes and smoking cessation efforts.

NCT ID: NCT04313673 Active, not recruiting - Preterm Labor Clinical Trials

Transabdominal Cervical Length Predict Preterm Labor During Routine Antenatal Screening

Start date: March 10, 2020
Phase:
Study type: Observational

Sonographically, cervical length measurement is widely used in obstetrics. Studies have revealed that early detection of short cervix can be a predictor of predicting preterm labor. Transvaginal ultrasonography has been shown as a reference method for the recognition of the short cervix, as well as it may be useful in the transabdominal evaluation in the studies conducted. In addition to the advantages of transvaginal evaluation, it is time consuming and disadvantages of some women during anxiety and discomfort during this procedure. Transabdominal ultrasonography, which provides a non-invasive evaluation, is more preferred by some patients than transvaginal. The aim of this study is to investigate the value of the cervical length measured by transabdominal route, which is a more acceptable method for pregnant women, in predicting preterm birth.

NCT ID: NCT04301518 Active, not recruiting - Preterm Birth Clinical Trials

Prematurity Risk Assessment Combined With Clinical Interventions for Improving Neonatal outcoMEs

PRIME
Start date: November 6, 2020
Phase: N/A
Study type: Interventional

This prospective, randomized, controlled study evaluates the safety and efficacy of a preterm birth (PTB) prevention strategy versus standard of care pregnancy management to reduce the incidence of adverse pregnancy outcomes.

NCT ID: NCT04296591 Completed - Preterm Birth Clinical Trials

This Study Was to Investigate the Efficacy of Fetal Right Heart Doppler Findings in Determination of Pulmonary Maturity

Start date: January 1, 2017
Phase:
Study type: Observational [Patient Registry]

Objective: The aim of this study was to investigate the efficacy of fetal right heart doppler findings in determination of pulmonary maturity. Materials and Methods: Pregnant women refered to the Department of Obstetrics and Gynecology at Karadeniz Technical University were included in the study. Pregnant women with pregestational or gestational diabetes mellitus, morbid obesity, thyroid dysfunction and fetal abnormality aneuploidy were not included in the study. The study was planned on women with late preterm and term pregnancy. Late preterm cases between 34-37 weeks were included in study group and term cases over 37 weeks were in control group. The doppler findings of main pulmonary artery and right pulmonary artery, mitral valve e/a wave ratio and lamellar body count were determined as the main outcomes. During caesarean section, 5cc amniotic fluid was taken to measure lamellar bodies count. Perinatal results of patients were recorded. p<0.05 was considered as statistical significance.

NCT ID: NCT04095507 Completed - Preterm Labor Clinical Trials

Uterocervical Angle in Patients With Preterm Premature Rupture of the Membranes

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

To evaluate the performance of uterocervical angle (UCA) in the prediction of labor timing in patients with preterm premature rupture of the membranes

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: 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: NCT03935152 Completed - Preterm Labor Clinical Trials

Oral Dydrogesterone in the Management of Preterm Labor

Start date: May 11, 2019
Phase: Phase 4
Study type: Interventional

This study evaluates the addition of oral dydrogesterone to standard treatment in the treatment of preterm labor. Half of participants will receive oral dydrogesterone and standard treatment, while the other half will receive oral placebo and standard treatment.

NCT ID: NCT03923023 Completed - Preterm Birth Clinical Trials

Impact of the PREEMI Package on Neonatal Mortality

PREEMI
Start date: November 1, 2014
Phase:
Study type: Observational [Patient Registry]

The purpose of this Quality Improvement initiative is to reduce severe morbidity and mortality among premature infants through proven and cost-effective clinical management during the antenatal, intrapartum, and postpartum periods. In order to reduce neonatal mortality and morbidity due to preterm birth complications, health facilities must be able to identify and manage women in preterm labor, accurately administer medications, and provide high-quality postnatal care.

NCT ID: NCT03837288 Recruiting - Preterm Labor Clinical Trials

Cervical Cerclage for Singleton Pregnant on Vaginal Progesterone With Progressive Cervical Length Shortening

Start date: April 22, 2019
Phase: N/A
Study type: Interventional

The aim of this study is to Determine whether cerclage with vaginal progesterone will: 1. Reduce the overall spontaneous preterm birth rate. 2. Prolong pregnancy latency. 3. Improve neonatal outcome. Compared to vaginal progesterone only, in patients with progressive cervical shortening. Research question: Does cervical cerclage reduce the overall spontaneous preterm births in patients with progressive cervical shortening. Research Hypothesis In this current study, the investigators hypothesize that cervical cerclage reduces spontaneous preterm births in patients with progressive cervical shortening on vaginal progesterone only.