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Pregnancy Preterm clinical trials

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NCT ID: NCT04362579 Completed - Pregnancy Preterm Clinical Trials

Advanced Multi-Modal Wearable Sensing for the Prediction of Pre-Term Labor

Start date: January 1, 2021
Phase:
Study type: Observational

Percent agreement of vital signs monitoring between the experimental sensor and standard of care monitoring

NCT ID: NCT04332393 Recruiting - Glycemic Control Clinical Trials

Metformin to Treat Corticosteroids-induced Hyperglycemia

Start date: May 15, 2020
Phase: Phase 4
Study type: Interventional

Antenatal corticosteroids, particularly, betamethasone is routinely administered to pregnant women at risk for preterm delivery to improve neonatal outcomes. Although antenatal betamethasone was shown to induce both maternal hyperglycemia and neonatal hypoglycemia, to date, there is insufficient data to establish whether treatment for maternal hyperglycemia, particularly, metformin, will decrease the risk for neonatal hypoglycemia, particularly of preterm neonates. In the present study the investigators will examine the effect of treatment with metformin on maternal glycemic control and hypoglycemia in preterm neonates following maternal betamethasone treatment.

NCT ID: NCT04154423 Recruiting - Premature Birth Clinical Trials

Engaging Mothers & Babies; Reimagining Antenatal Care for Everyone (EMBRACE) Study

EMBRACE
Start date: November 7, 2019
Phase: N/A
Study type: Interventional

This is a randomized comparative effectiveness study of two forms of enhanced prenatal care among 2,600 Medi-Cal eligible pregnant women in Fresno, California. The goal is to see whether group prenatal care with wrap around services versus individual prenatal care supplemented by services covered by the California Department of Public Health Comprehensive Perinatal Services Program (CPSP) results in lower rates of preterm birth, less depression and anxiety, and more respectful and greater satisfaction with prenatal care.

NCT ID: NCT04074525 Completed - Extreme Prematurity Clinical Trials

Evaluating Decisional Regret Among Mothers

Start date: March 24, 2020
Phase:
Study type: Observational

The anticipated birth of an extremely low gestational age infant presents many complex and ethically challenging questions, including whether to initiate resuscitation or comfort care after delivery. Failure to identify and align decision-making to parents' values during periviabilty counseling may result in greater opportunity for decisional regret. The goal of the proposed research is to assess decisional regret in mothers of extremely premature births and to compare decisional regret in mothers who chose resuscitation at time of delivery to those who chose comfort care. Approximately 1000 mothers of infants born extremely premature at 2 perinatal centers in the US will be surveyed.

NCT ID: NCT03956810 Completed - Pregnancy Preterm Clinical Trials

Evaluation of the Prenatal Trip Assistance Pilot Project

Start date: May 31, 2019
Phase: N/A
Study type: Interventional

The prenatal trip assistance project is a study comparing two methods of delivering transportation assistance to pregnant women living in communities with high rates of infant mortality. Franklin County, Ohio, home of the state's capital of Columbus, has one of the highest rates of infant mortality in the U.S. at 8.2 per 1,000 live births.There have been many advances in "smart" applications in transportation over the past 10 years. However, despite the fact that the vast majority of impoverished women have a mobile phone, the transportation providers currently used by the Medicaid managed care plans are low tech with no mobile alerts or two-way communication with the woman. The purpose of the proposed study is to examine the preliminary efficacy of providing expanded and "smart" transportation services to increase communications, reliability, and customer satisfaction and reduce adverse pregnancy outcomes among women whose children are at high risk of infant mortality. The investigators aim to enroll and randomize 500 eligible pregnant women to either on-demand services or usual transportation services as provided by their Medicaid managed care organization. The primary outcome for the proposed trial will be overall satisfaction with transportation services as assessed by the final study questionnaire (i.e., two months after delivery or miscarriage) and secondary outcome measures will include: adequacy of prenatal care, preterm birth and infant mortality.

NCT ID: NCT03785795 Completed - Preterm Labor Clinical Trials

Multichannel EMG Diagnosing True Preterm Labor

PTL
Start date: November 25, 2018
Phase:
Study type: Observational

We have designed new electromyography sensors for measuring uterine activity. These sensors are directional - they preferentially report uterine muscle contractions at specific locations, called regions. By measuring the synchronization of the regions of the uterus during contractions we intend to non-invasively determine if any patient is in-labor or not-in-labor. Accurately diagnosing true preterm labor allows timely intervention to avoid preterm birth; Accurately diagnosing false preterm labor avoids needlessly treating patients who would not benefit.

NCT ID: NCT03738293 Withdrawn - Prematurity Clinical Trials

Continuous Glucose Monitoring of Late Preterm Birth After Corticosteroids

Start date: December 2019
Phase:
Study type: Observational

Women undergoing late preterm birth are at high risk of delivering a newborn with neonatal hypoglycemia. The investigators plan to monitor interstitial glucose levels prior to delivery in these women in order to develop a better understanding of the relationship between maternal hyperglycemia and neonatal hypoglycemia.

NCT ID: NCT03675061 Completed - Pregnancy Preterm Clinical Trials

Evaluation of Vaginal PAMG-1 Detection by PartoSure Test in Preterm Delivery Threat in Actual Clinical Situation: Randomized Controlled Trial

PARTO-MAP
Start date: December 11, 2018
Phase: N/A
Study type: Interventional

Prematurity is defined as birth before 37 weeks of amenorrhea. It is the leading cause of perinatal morbidity and mortality. It is estimated that premature births to 15 million worldwide in 2010, including 60,000 children in France (7,4% of births) and 12000, born before 32 weeks of amenorrhea (term defining great prematurity). More than half of these births follow spontaneous work. Before 34 weeks of amenorrhea, prematurity requires specific maternal-fetal management centered primarily on antenatal corticosteroid treatment for fetal maturation including 2 intramuscular injections at 24 hour intervals. This cure can only be done once and its benefit is proven in the 7 (to 14) days before the birth (recommendation for the clinical practice of the French National College of Obstetricians and Gynecologists of December 2016). The single course of antenatal corticosteroids before 34 weeks of amenorrhea is associated in the neonatal period with reduction in morbidity and mortality, and in the long term with an improvement of the survival without sequelae, if the full cure is administered in the 7, to 14, days before birth. The second key element of the management of a premature delivery threats is the admission in a pediatric structure adapted to the degree of prematurity. The care of a premature delivery threats before 34 weeks of amenorrhea care leads to hospitalization with possible transfer to a maternity of pediatric adapted level, tocolysis, a biological and bacteriological assessment, and, sometimes, other examinations and treatments. The prediction of premature labor is a challenge. Current methods, such as vaginal examination, cervicometry and detection of fetal fibronectin, make it possible to obtain a negative predictive value (NPV) approaching 100% but a poor positive predictive value (PPV), thus 8 out of 10 patients hospitalized and treated for premature delivery threat no not give birth within 7 days, or even before 34 weeks of amenorrhea. A better prediction of preterm delivery has two benefits: administer antenatal corticosteroid therapy in high-risk patients at the right time and not treat not-at risk patients. The PartoSure® test, which detects the placental protein vaginal alphamicroglobulin-1 (PAMG-1), has satisfactory metrological qualities according to observational studies : NPV 98% and PPV 75% of delivery within 7 days. However this test has never been evaluated in real clinical condition. In our study, the result of the test becomes decisional for the care. The hypothesis is that use of this test will improve the prediction of preterm delivery during a first consultation for preterm delivery threat and thus allow more frequent prenatal corticosteroid treatment in optimal period, avoiding treating non-at risk patients.

NCT ID: NCT03429257 Completed - Clinical trials for Inflammatory Response

Maternal EED and Aflatoxin Birth Outcomes Study Uganda

Start date: February 1, 2017
Phase: N/A
Study type: Observational

This prospective cohort study focuses on the relationship between maternal environmental enteric dysfunction (EED) and maternal aflatoxin B1 exposure and birth outcomes, particularly infant anthropometry and gestational age, in Mukono, Uganda.

NCT ID: NCT03076775 Completed - Clinical trials for Neonatal Hypoglycemia

Euglycemia After Antenatal Late Preterm Steroids, the E-ALPS Study

E-ALPS
Start date: June 8, 2017
Phase: N/A
Study type: Interventional

Annually in the U.S 300,000 neonates are born late preterm, defined as 34 weeks 0 days - 36 weeks 6 days. The Antenatal Late Preterm Steroids (ALPS) Trial demonstrated that maternal treatment with betamethasone in the late preterm period significantly reduces neonatal respiratory complications, but also increases neonatal hypoglycemia, compared to placebo. This research study will attempt to answer the following primary question: Does a management protocol aimed at maintaining maternal euglycemia after ALPS decrease fetal hyperinsulinemia, compared to usual antepartum care?