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Preterm Birth clinical trials

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NCT ID: NCT00883974 Completed - Preterm Birth Clinical Trials

Sensitivity Training For Parents of Preterm Infants

Start date: April 2004
Phase: N/A
Study type: Interventional

Immediately following birth, preterm infants face a period of stressful environmental inputs, which may have negative consequences on early brain development and subsequent neurobehavioral outcomes. This study aimed to assess the effectiveness of training parents in reducing stressful experiences early in life. The investigators hypothesized that this intervention would insulate preterm infants from the harmful effects of acute and chronic stress, which in turn would result in enhanced brain development. The primary aim of the current study was to investigate if this intervention was associated with improved brain development measured by magnetic resonance imaging (MRI) at term-equivalent age. A secondary aim was to assess some possible short-term medical benefits.

NCT ID: NCT00860470 Completed - Preterm Birth Clinical Trials

Antenatal Micronutrient Supplementation and Infant Survival

JiVitA-3
Start date: January 2008
Phase: Phase 3
Study type: Interventional

The purpose of this community-based randomized trial is to examine whether a daily antenatal and postnatal multiple micronutrient supplement given to women will enhance newborn and infant survival and health and other birth outcomes in a rural setting in northwestern Bangladesh.

NCT ID: NCT00830765 Completed - Preterm Birth Clinical Trials

The Use of Progesterone to Reduce Preterm Birth

Start date: June 2004
Phase: N/A
Study type: Interventional

Preterm birth is the most common and costly complication in obstetrics. It complicates up to 11 % of all pregnancies and it is responsible for 70% of sick babies. Recently two studies have shown that giving progesterone (a normal hormone made by the ovaries) prolongs gestation in women who have had a preterm birth in an earlier pregnancy (and therefore are at risk for another early delivery). There are other studies that show that this technique of giving a weekly shot of progesterone does not prevent preterm birth. In addition, There are other groups of patients who are at very high risk for preterm birth which have not been studied. They include: 1.) Cervical cerclage (a stitch in the mouth of the womb); 2.) Multifetal gestation (twins, triplets, etc.); 3.) Women with preterm (<34 weeks) rupture of the membranes; 4.) Women with preterm labor during the current pregnancy with intact membranes who have been tocolyzed (have their labor stopped and are getting ready to go home). We purpose to give weekly shots of progesterone or a placebo in a randomized fashion to women in the first group who are at risk for preterm delivery due to an early birth in a previous pregnancy as well as the other four groups listed. If progesterone given weekly is successful at preventing early delivery as compared to the placebo group then great benefit for these women as well as future pregnancies would be accrued.

NCT ID: NCT00735137 Completed - Preterm Birth Clinical Trials

Randomized Study of Pessary Versus Standard Management in Women With Increased Chance of Premature Birth

Start date: August 2008
Phase: Phase 3
Study type: Interventional

The aim of the study is to determine the effect of cerclage pessary on the incidence of spontaneous delivery between randomization (at 20-24+6 weeks) and 33+6 weeks in asymptomatic women with singleton pregnancies found at routine mid-trimester screening to have a cervix of <25 mm in length and in twin pregnancies.

NCT ID: NCT00706264 Completed - Preterm Birth Clinical Trials

Prevention of Preterm Birth Using Cervical Pessary in Pregnant Women With Short Cervix

PECEP
Start date: June 2007
Phase: N/A
Study type: Interventional

Placement of a vaginal pessary reduces significantly the rate of spontaneous preterm birth in pregnant women with short cervical length at 18-22 weeks scan.

NCT ID: NCT00701350 Completed - Preterm Birth Clinical Trials

Biomarkers of Intra-amniotic Infection in Women With Preterm Premature Ruptured Amniotic Membranes

PPROM
Start date: June 2008
Phase: N/A
Study type: Observational

The purpose of this study is to investigate the expression of protein biomarkers in cervical vaginal fluid in women with preterm premature rupture of membranes (PPROM)

NCT ID: NCT00582374 Withdrawn - Preterm Birth Clinical Trials

Periodontal Disease and Preterm Birth

Start date: March 2005
Phase: N/A
Study type: Observational

To determine the relationship between periodontal disease and upper genital tract inflammation in pregnancy. To determine whether certain fluid levels in the oral cavity and the vagina are associated with preterm birth or low-birth weight.

NCT ID: NCT00579839 Completed - PreTerm Birth Clinical Trials

Trial of Immediate vs. Delayed Cord Clamping in the Preterm Neonate

Start date: October 2006
Phase: N/A
Study type: Interventional

To determine the short and long term effects of placental transfusion at birth by milking and delayed cord clamping of the umbilical cord in neonates born between 24 weeks 0 days and 34 weeks 0 days weeks' gestation.

NCT ID: NCT00579150 Terminated - Type 2 Diabetes Clinical Trials

Exenatide Pregnancy Registry - Type 2 Diabetes in Pregnancy

Exenatide
Start date: January 2009
Phase: Phase 4
Study type: Observational

This is an observational, prospective cohort study describing pregnancy outcomes in women with pre-existing (prior to pregnancy) type 2 diabetes who have been exposed to any formulation of exenatide during pregnancy. The pregnancy registry will compare the occurrence of the pregnancy outcomes of interest with those collected from a prospective group of women with pre-existing type 2 diabetes who have been exposed to one or more antidiabetic medications other than exenatide during pregnancy. Insulin exposures are acceptable in both groups but must be in addition to one or more other antidiabetic medications in the non-exenatide group. The primary study objective is to evaluate the percentage of major birth defects (i.e., those that caused significant functional or cosmetic impairment, required surgery, or were life-limiting) following use of exenatide during pregnancy for treatment of type 2 diabetes compared to the percentage of major birth defects following use of one or more antidiabetic medications other than exenatide during pregnancy for treatment of type 2 diabetes. The secondary objectives of the Exenatide Pregnancy Registry are to evaluate the percentage of other adverse pregnancy outcomes (e.g., spontaneous abortion, stillbirth, preterm birth) and any potential impact of exenatide use during breastfeeding among pregnancies or births in women who used exenatide for pre-existing type 2 diabetes: This study is being conducted in the United States (US). Enrollment in the Registry is voluntary. The Exenatide Pregnancy Registry is sponsored by AstraZeneca and is managed by INC Research, LLC. The scientific conduct and analysis of the Registry is overseen by a Registry Review Committee (RRC) consisting of experts in maternal and fetal medicine, teratology/genetics, epidemiology, type 2 diabetes in pregnancy and/or pediatrics.

NCT ID: NCT00502697 Completed - Preterm Birth Clinical Trials

Tennessee Connections for Better Birth Outcomes

BBO
Start date: November 2006
Phase: N/A
Study type: Interventional

Women with a history of a prior preterm birth (PTB) have a high probability of a recurrent preterm birth. Some risk factors and health behaviors that contribute to PTB may be amenable to intervention. Home visitation is a promising method to deliver evidence based interventions. We evaluated a system of care designed to reduce preterm births and hospital length of stay in a sample of pregnant women with a history of a PTB. All participants (N = 211) received standard prenatal care. Intervention participants (N = 109) also received home visits by certified nurse-midwives guided by protocols for specific risk factors (e.g., depressive symptoms, abuse, smoking). Data was collected via multiple methods and sources including intervention fidelity assessments. Average age was 27.6 years. Racial breakdown mirrored local demographics. Most women had a partner, a high school education, and Medicaid. Enhanced prenatal care by nurse-midwife home visits may limit some risk factors and shorten intrapartum length of stay for women with a prior PTB. This study contributes to knowledge about evidence-based home visit interventions directed at risk factors associated with PTB.