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Preterm Birth clinical trials

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NCT ID: NCT02394444 Completed - Preterm Birth Clinical Trials

Impact of an Intervention Program on Parenting Stress After Preterm Birth

IDEX
Start date: June 2006
Phase: N/A
Study type: Interventional

The aim of this study was to assess the impact of an early psychological intervention, Triadic parent-infant Relationship Therapy (TRT), on parenting stress, parental mental health, and preterm infant development in the motor, cognitive, emotional and behavioral domains at a corrected age of 18 months.

NCT ID: NCT02379832 Completed - Preterm Birth Clinical Trials

Pre-Eclampsia And Growth Restriction: a Longitudinal Study

PEARL
Start date: March 2015
Phase:
Study type: Observational [Patient Registry]

Preeclampsia may have several causes leading to different characteristics of the pathology. Differentiation between the "type of preeclampsia" would help to treat patients more accurately. This project aims to identify early markers that are specific to each type of preeclampsia (early or late, with or without growth restriction). Through a case-control study, many data will be collected prospectively (serum markers, ultrasonographic markers, maternal factors) among nulliparous women with no sign of preeclampsia (as soon as the first trimester) and nulliparous women with preeclampsia (at diagnosis).

NCT ID: NCT02350231 Completed - Preterm Birth Clinical Trials

Progesterone Vaginal Pessary for Prevention of Preterm Twin Birth

PPPTP
Start date: February 1, 2014
Phase: Phase 2/Phase 3
Study type: Interventional

Multiple pregnancies accounted for 1 - 6 % of all births in UK during 2007. More than 98% of these multiple births being twin births . Preterm birth defined as birth occurring prior to 37 weeks of gestation and it was about 15 % of pregnancies in developed world and 12.7 % in the United States. Preterm birth is the leading cause of infant and neonatal mortality. Premature neonates are at increased risk of developing respiratory distress syndrome, sepsis, intraventricular hemorrhage, and necrotizing enterocolitis. Twin pregnancy is considered one of the important risk factors of preterm birth. Over distension of uterus may be one of the etiological factors for preterm birth. However, no definite effective interventions have been shown to prevent preterm delivery in twin pregnancy. Three large randomized trials suggested that progesterone might prevent preterm delivery in high-risk singleton pregnancy especially those with previous preterm delivery or short cervix might be reduced by antenatal progesterone. Fonseca et al (2007) concluded that women with short cervix are less likely to deliver preterm ≤34 weeks if they are treated with vaginal progesterone.

NCT ID: NCT02333227 Completed - Preterm Birth Clinical Trials

Saving Lives at Birth: Primary Prevention of Periodontal Disease in Relation to Preterm Birth in Malawi

PPaX
Start date: May 1, 2015
Phase: N/A
Study type: Interventional

The hypothesis of the investigators' project is that comprehensive primary preterm birth prevention, inclusive of maternal oral health with xylitol chewing gum (the intervention), will reduce the rate of periodontal disease and caries, preterm birth prevalence, and neonatal mortality.

NCT ID: NCT02317315 Completed - Preterm Birth Clinical Trials

Biomarkers Associated With Spontaneous Preterm Birth Less Than 32 Wks Gestation

Start date: January 2013
Phase: N/A
Study type: Observational

Preterm delivery (PTD) is a leading cause of neonatal mortality and continues to be a major public health concern, reaching 12.9% in 2006, despite intense research to reverse this trend. Currently, fetal fibronectin (fFN) screening and cervical length determined by ultrasound are two tests which are proven to have benefit in the identification of those at greatest risk for preterm delivery. However the benefit of these tests is limited to situations where a negative result can avoid unnecessary interventions. Currently, maternal fetal monitoring is limited, as it is difficult to "see" what is going on in the placenta (maternal-fetal interface) without invasive measures such as placental biopsy or amniocentesis. Our goal for this study is to identify a group of biomarkers in non-invasive compartments (such as saliva, blood, urine, and/or cervical and vaginal secretions) that are associated with preterm labor and birth. We hypothesize that preterm labor will display an inflammatory profile, which consists of unique inflammatory biomarkers from different non-invasive bodily fluid compartments (such as Il-10 in urine, VEGF in cervical secretions, and IP-10 in saliva), that correlates with a high incidence of preterm birth.

NCT ID: NCT02229526 Completed - Preterm Birth Clinical Trials

Fish Oil Trials in Pregnancy for the Prevention of Pregnancy Complications ('FOTIP')

FOTIP
Start date: January 1990
Phase: N/A
Study type: Interventional

The initial trial examined if fish oil supplementation during pregnancy could reduce the risk of pregnancy induced hypertension, intrauterine growth retardation, and preterm birth in pregnancies that were at increased risk of these complications. The study was designed as a multi-centre clinical trial based in 19 hospitals in seven countries in Europe.

NCT ID: NCT02225353 Completed - Preterm Birth Clinical Trials

Efficacy Study of a Cervical Pessary Containing Progesterone for the Prevention of Preterm Delivery

PCP002
Start date: September 2, 2013
Phase: Phase 2
Study type: Interventional

Assess the efficacy of 2 Cervical Pessaries containing 6.3 g and 7.7 g micronized progesterone for the prevention of preterm delivery, established through spontaneous birth before gestation weeks 32 (31 weeks and 6 days) and 34 (33 weeks and 6 days), when the pessary is inserted during weeks 16th and 24th and removed at 36 weeks and 6 days in pregnant women at high risk of premature birth.

NCT ID: NCT02189148 Completed - Preterm Birth Clinical Trials

First-trimester Prediction of Preeclampsia

PREDICTION
Start date: November 2014
Phase:
Study type: Observational

Preeclampsia is a complication of pregnancy related to adverse maternal and neonatal outcomes, including fetal growth restriction and perinatal death. Several measures are used or under investigation (low-dose aspirin, low-molecular weight heparin, calcium, folic acid, among others) for the prevention of preeclampsia. Unfortunately, most high-risk women who could benefit from those preventive measures are not identified until late in pregnancy. Recent evidences suggest that the investigators could identify women at risk of developing preeclampsia using a combination of serum and ultrasound biomarkers in the first-trimester of pregnancy. This screening test needs external validation. A first-trimester screening strategy will strengthen clinical research on preeclampsia and will contribute to the development of strategy combining the prediction and prevention of the disease and its related complications.

NCT ID: NCT02145767 Completed - Preterm Birth Clinical Trials

Progesterone for the Prevention of Miscarriage and Preterm Birth in Women With First Trimester Bleeding: PREEMPT Trial

Start date: December 2014
Phase: Phase 2
Study type: Interventional

Miscarriages and preterm births are common and serious events affecting women, families, and healthcare systems on many levels. One of the risk factors for miscarriage and preterm birth is bleeding in the first trimester of pregnancy. Progesterone, a hormone that plays a key role during pregnancy, has been proposed as a possible medication to be used in pregnancy to prevent miscarriage and preterm birth among women who have bleeding in their first trimester of pregnancy. Unfortunately, unless sound clinical evidence is obtained through a clinical trial, whether or not progesterone can indeed prevent miscarriage and preterm birth remains uncertain and thus is not a recommended treatment in women with early pregnancy bleeding. The purpose of our study is to evaluate the effect of progesterone for the prevention of miscarriage and preterm birth among women with early pregnancy bleeding. We will carry out a clinical trial in which 850 women will be randomized to receive either progesterone supplementation (425 women) or a similarly appearing placebo (425 women) and the outcome of their pregnancy will be compared.

NCT ID: NCT02139800 Completed - Preterm Birth Clinical Trials

Sustained Aeration of Infant Lungs Trial

SAIL
Start date: August 27, 2014
Phase: N/A
Study type: Interventional

This study is a 2-arm randomized, controlled, multi-center clinical trial to determine which of two strategies at birth are best to optimally aerate the lung of preterm infants. Specifically we will determine in 600 infants of 23-26 weeks gestational age (GA) requiring respiratory support at birth which of two lung opening strategies - either a standard PEEP/CPAP of 5-7 cm H2O in the delivery room (DR), as compared to early lung recruitment using Sustained Inflation (SI) in the DR, will result in a lower rate of the combined endpoint of death or bronchopulmonary dysplasia (BPD) at 36 weeks gestational age. Hypotheses: 1. Early lung recruitment with SI superimposed upon standard PEEP/CPAP in the DR will reduce the need for mechanical ventilation in the first seven days of life, and reduce need for surfactant use; and 2. A policy of DR SI on standard PEEP/CPAP recruitment will confer better outcomes at 36 weeks post-menstrual age (PMA) than standard PEEP/CPAP