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Preterm Birth clinical trials

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NCT ID: NCT02103231 Completed - Hypertension Clinical Trials

Young Adult Cardiovascular Health sTudy

YACHT
Start date: May 2014
Phase: N/A
Study type: Observational

The purpose of this study is to understand more about why young people who were born prematurely may have increased risk of high blood pressure and lower cardiovascular exercise capacity.

NCT ID: NCT02092688 Completed - Preterm Birth Clinical Trials

Evaluation of a Novel Diagnostic Kit for the Detection of Placental Alpha-Microglobulin-1 in the Prediction of Preterm Birth

Start date: December 2013
Phase:
Study type: Observational

This is a prospective observational trial that will enroll pregnant women between 24 and 36 6/7 weeks of gestation that present with signs and symptom of preterm labor with clinically intact membranes and cervical dilatation ≤ 3 cm and a control group of pregnant women without signs and risks for PTL to assess how the results of the novel kit for the detection of PAMG-1 in both patient groups correlate to their time-to-delivery (TTD) and other adverse neonatal and pregnancy outcomes. Thes study hypothesis contains that the novel diagnostic kit will identify women who are at high risk for preterm birth by a high positive predictive value.

NCT ID: NCT02056652 Completed - Preterm Birth Clinical Trials

Prevention of Preterm Birth With a Pessary in Singleton Gestations

PoPPS
Start date: February 2014
Phase: N/A
Study type: Interventional

Preterm birth (PTB) is associated with over one million infant deaths annually worldwide. The incidence of PTB in the United States is 11.5% with more than 500,000 deliveries occurring at less than 37 weeks gestation annually. The rate of PTB in the United States increased to 12.8% in 2006, and remains high compared to almost all other developed countries, despite the introduction of many public health and medical interventions designed to delay PTB. Weekly treatment with 17-alpha hydroxyprogesterone caproate beginning at 16-20 weeks gestation has been shown to significantly reduce the risk of PTB and is currently recommended for women who experienced spontaneous PTB in a prior pregnancy. However, a strategy for the prevention of spontaneous PTBs in which therapeutic intervention is restricted to women with a previous PTB is likely to have a small effect on the overall rate of prematurity since only about 10% of spontaneous PTBs arise in women with such a history. A major reduction in rates of mortality and morbidity in premature babies will only be achieved with increased precision in the identification of women at risk of spontaneous PTB and through the development of an effective prevention for this complication. Transvaginal ultrasound measurement of cervical length is a reliable screening test for prediction of PTB. Although treatment with vaginal progesterone is effective in decreasing PTB in women with a short cervix, over 30% of women still experience premature delivery and many women find daily administration of progesterone to be challenging. Preliminary studies have suggested that use of an intravaginal pessary may be effective in preventing PTB. If effective this approach would be particularly appealing because of the wide availability of pessaries, ease of use, and low cost. Unfortunately, existing studies are inadequate to confirm effectiveness; a well designed, properly powered, prospective randomized trial is warranted prior to widespread implementation in clinical practice. We propose such a trial to study the effectiveness of the pessary in decreasing the incidence of PTB in an inner city Philadelphia population.

NCT ID: NCT02032186 Completed - Preterm Birth Clinical Trials

A Randomized Clinical Trial of Oral Magnesium Supplementation in Pregnancy

Start date: March 2014
Phase: Phase 3
Study type: Interventional

The investigators propose a preventive strategy that may reduce the risk of placental vascular disease and its negative consequences for both the fetus (e.g., poor fetal growth or stillbirth)and mother (e.g., the hypertensive disorders of pregnancy), and which, in turn, should reduce the need for indicated preterm delivery. This strategy is a multicenter, randomized double-blind, placebo-controlled clinical trial (RCT) comparing magnesium citrate supplementation with placebo, each starting at 12 to 20 weeks gestation and continued until delivery. Magnesium citrate is a safe and inexpensive compound that is easily absorbed by the intestinal tract. The results of this RCT may be especially relevant in low and middle income countries that have high rates of prematurity, and limited resources for acute newborn and maternal care.

NCT ID: NCT02030106 Completed - Preterm Birth Clinical Trials

Motherhood and Microbiome

M&M
Start date: October 2013
Phase: N/A
Study type: Observational

This is a prospective cohort, enriched with women with a prior term birth, of singleton pregnancies who will be followed for the outcome of preterm birth. The main exposure of interest is the characterization of the cervico-vaginal microbiota. Women will be recruited from a population seeking routine obstetrical care at obstetrical practices at Penn. They will have three research visits during pregnancy to complete questionnaires and collect samples of cervico-vaginal fluid and cervical cells. Outcome data will be collected about the prenatal events and timing of delivery.

NCT ID: NCT01974531 Completed - Pregnancy Clinical Trials

Psychological Distress & Stress in Parents With Preterm infants-a Prospective Study

Start date: January 2013
Phase:
Study type: Observational [Patient Registry]

The purpose of the present prospective study is the analysis of risk and protective factors of perinatal stress and psychological distress of parents with or without a preterm child. Stress is measured biologically by Cortisol levels and psychologically by a questionnaire. Different outcomes of psychological distress (e.g. anxiety, depression, posttraumatic stress disorder, burnout) are measured by various questionnaires. We analyze the influence of different aspects as personality traits, social support, partnership.

NCT ID: NCT01963065 Completed - Preterm Birth Clinical Trials

NICU-HEALTH (Hospital Exposures and Long-Term Health)

Start date: March 1, 2015
Phase:
Study type: Observational

The purpose of this study is to evaluate the impact of environmental exposures during the NICU hospitalization on preterm infant development. The research team is interested in both chemical and non-chemical exposures. Research studies have shown that babies are exposed to plasticizers (bisphenol A, phthalates) in the NICU. Plasticizers are chemicals that are used to make plastic medical equipment soft and flexible. The research team wants to find out whether NICU-based exposure to chemicals (including common plasticizers) and other non-chemical exposures like stress makes a difference to how they grow and develop.

NCT ID: NCT01954095 Completed - Preterm Birth Clinical Trials

The Impact of Vaginal and IM Progestins on the Cervix

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

The purpose of this study is to analyze how the body handles and responds to progesterone treatment in parous and nulliparous women at risk of pre-term birth.

NCT ID: NCT01851668 Completed - Preterm Birth Clinical Trials

Preterm Infant Transport Stress (PremiTranS) Study

PremiTranS
Start date: June 2013
Phase: N/A
Study type: Observational

This is an observational pilot study to quantify the amount of vibration, noise, physiological and biochemical instability that premature babies are exposed to during inter-hospital transport.

NCT ID: NCT01800825 Completed - Pregnancy Clinical Trials

Clindamycin to Reduce Preterm Birth in a Low Resource Setting

Start date: July 2013
Phase: Phase 4
Study type: Interventional

Preterm birth has been linked to certain types of vaginal infections. The goal of this study is to determine if giving women pregnant between 13-20 weeks with an elavated vaginal pH(evidence of this type of infection)Oral Clindamycin(an antibiotic)will have a lower rate of preterm birth compared to women given a placebo(starch)