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High Risk Pregnancy clinical trials

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NCT ID: NCT01783210 Recruiting - Clinical trials for Dietary Modification

Pregnancy Complications in Women With BMI>25 kg/m2 Enrolled in a Healthy Lifestyle and Eating Habits Program

TLC
Start date: July 2012
Phase: N/A
Study type: Interventional

The investigators evaluate if changing eating habits and introducing a correct lifestyle in women with BMI >25 Kg/m2 would improve unfavorable maternal-fetal outcomes associated with excessive weight gain (EWG) during pregnancy. To pursue these goals, eligible women are randomly assigned to no intervention (Control group) that receive only a simple nutritional booklet about lifestyle and healthy diet during pregnancy without explicit caloric restriction or the Therapeutic Lifestyle Changes Program (TLC group) that receive a caloric restriction (1500 Kcal/day divided in3 main meals and 3 snacks + 300 kcal/die for overweight or 200 kcal/die for obese women submitted to energy expenditure program) associated to a mild physical activity (30 minutes at least 3 days/week) The investigators use a tool that could easily and practically evaluate not only total GWG at term, but also changes in maternal body composition: the bioimpedance analyzer.

NCT ID: NCT01708746 Completed - High Risk Pregnancy Clinical Trials

Investigation of the Impact of Noninvasive Prenatal Testing for Fetal Aneuploidy on Utilization of Prenatal Diagnostic Procedures and Pregnant Women's Views

Start date: November 2012
Phase: N/A
Study type: Observational

This is a prospective, single-institution observational study to be conducted at 4 clinics within the Southern California Permanente Medical Group. Pregnant women who present for prenatal genetic counseling at the designated clinics and who meet study eligibility criteria will be offered the option of the verifi® prenatal test by a trained, licensed and certified genetic counselor (GC) . Women who elect the verifi® prenatal test will have a blood sample drawn by peripheral venipuncture that will be sent to the Verinata Health CAP-accredited clinical laboratory (Redwood City, CA). Results will be reported to the ordering health care provider by the laboratory within 8-10 business days and will be shared with the subject by their provider. Subject care and decision-making following NIPT result will be clinically managed by the provider with his/her subject and is not dictated by the study protocol. All eligible women who provide informed consent, whether they elect or decline NIPT will be asked to complete a short questionnaire on their views of prenatal testing. The uptake of invasive prenatal procedures (CVS and/or amniocentesis) by the total prospective cohort will be collected through review of electronic medical records (EMR). A historical cohort with matched demographic and pre-test indications to the prospective cohort will be identified from the EMR for comparison in the primary analysis.

NCT ID: NCT01649167 Completed - High-Risk Pregnancy Clinical Trials

Longitudinal Measures of Leptin in Pregnant Women Who Developed Preeclampsia

Start date: February 2009
Phase: N/A
Study type: Observational

Background: Obesity in pregnancy is increasing and is a risk factor for metabolic pathology such as preeclampsia. Leptin is an adipokine which has a direct relationship to obesity. Aim: to measure leptin in lean, obese and diabetic pregnant women at three months intervals throughout their pregnancies. Methods: Pregnant women were recruited in the 1st trimester of pregnancy, and three groups were formed: a) with pregestational Body Mass Index (BMI) less than 25 kg/m2, b) BMI higher than 25 kg/m2 and c) with Gestational Diabetes Mellitus (GDM). Serum levels of leptin were measured with radioimmunoassay (RIA) technique.

NCT ID: NCT01594463 Active, not recruiting - Clinical trials for Fetal Growth Retardation

Routine Ultrasound Screening in the Third Trimester

RECRET
Start date: May 2012
Phase: N/A
Study type: Interventional

Late intrauterine growth restriction is infrequently diagnosed with an overall sensitivity of 40 % in low-risk pregnancies. In addition, late intrauterine growth restriction may be associated with intrauterine death and poor neonatal outcomes i.e. birth asphyxia and hospitalization in intensive care unit. The investigators hypothesis that a later third trimester routine ultrasound may be more accurate to diagnose late intrauterine growth restriction.

NCT ID: NCT01355822 Completed - High Risk Pregnancy Clinical Trials

Impact of the NO-donor Pentaerythrithyltetrantrate on Perinatal Outcome in High-risk Pregnancies

Start date: April 2002
Phase: Phase 1/Phase 2
Study type: Interventional

Pregnancies resulting in IUGR and also in preeclampsia are strongly associated with typical underlying placental pathology revealing small placentas and maldevelopment of the decidual blood vessels, suggesting under-perfusion from the maternal circulation. Since nitric oxide (NO) donors can improve decreased uteroplacental perfusion without any negative effects on fetal circulation, these may prevent negative pregnancy outcomes in patients at risk. The aim of this study is to evaluate the effectiveness of the long-lasting NO donor pentarythrithyltetranitrate (PETN) to reduce the likelihood of adverse pregnancy outcomes (intrauterine growth retardation / IUGR, perinatal death, placental abruption, and preterm delivery) in women recognized to be at risk for this outcome by abnormal uterine flow in mid gestation.

NCT ID: NCT01281319 Recruiting - Preterm Labor Clinical Trials

Evaluation of a Serology Diagnostic Kit for the Detection of Genital Mycoplasma in Pregnancy

Start date: January 2011
Phase: N/A
Study type: Observational

Subclinical urogenital infections have been implicated in up to 70% of adverse pregnancy outcome, especially preterm labor and delivery. The most prevalent microorganisms involved in intrauterine infections are urogenital Mycoplasmas. Diagnosis by culturing or PCR merely detect the presence of the bacteria, pointing to colonized carriers only. There is no efficient and reliable diagnostic test to identify those subjects that have developed an infectious disease and are at risk of developing adverse pregnancy outcome. In order to identify women at risk for developing pregnancy complications, Promyco Diagnostics has developed a proprietary, simple and non-invasive serology diagnostic kit for the detection of urogenital Mycoplasma infection.

NCT ID: NCT00722085 Completed - High Risk Pregnancy Clinical Trials

Amniotic Fluid Sludge in Cerclage Patients as an Indicator for Increased Risk of Preterm Delivery and Neonatal Outcome.

Start date: January 2008
Phase: N/A
Study type: Observational

Amniotic Fluid "Sludge" Does Not Increase Risk of Preterm Delivery in Cerclage Patients.

NCT ID: NCT00546026 Not yet recruiting - High-Risk Pregnancy Clinical Trials

Does Mid-Gestation Placental Function Assessment Reduce Psychological Distress in Women With High-Risk Pregnancies?

Start date: n/a
Phase: Phase 1
Study type: Interventional

Women whose pregnancies are at judged to be at risk of a poor outcome from an early delivery due to medical problems such as diabetes or high blood pressure, are often very anxious during pregnancy, at least until they know they have passed the risk period of premature birth (after 8 months). Anxiety itself can have a significant effect on the developing baby, on the newborn child and the mother-infant bonding process. We will use a combination of pregnancy blood tests and an ultrasound assessment to check on placental function, since placental damage is the greatest cause of poor outcome. Most women tested this way will have normal results, and so may feel reassured and do better in pregnancy than untested women. The benefits may extend after birth to mother-infant bonding, breastfeeding success and a reduced risk of postnatal depression. We will randomly select an equal number of women for testing and no testing (like tossing a coin, known as a randomized control trial) to be confident that any benefits observed are genuine. The potential benefits of our research would be substantial for the mental health of many pregnant women, for their newborn and for their children as they grow up. The tests are easy to do and would add very little in terms of a woman's and in terms of the total costs of prenatal care.

NCT ID: NCT00004566 Completed - High Risk Pregnancy Clinical Trials

Study of Fetal Swallowing

Start date: February 2000
Phase: N/A
Study type: Observational

This study will establish a database of fetal movements associated with feeding. It will use information obtained from standard fetal ultrasound procedures to identify and measure the growth of the baby's face, lips, tongue, jaw, throat and airway. Fetal movements involved in breathing, sucking and swallowing will be recorded on videotape. This study may provide information that will: increase knowledge about how swallowing develops in the fetus; help explain why some babies have difficulty sucking and swallowing at birth; help predict what babies are at increased risk for feeding problems; and help design better ways to manage feeding difficulties in babies. Pregnant women scheduled for ultrasound examination at the National Naval Medical Center in Bethesda, Maryland, or Georgetown University Hospital in Washington, D.C., are eligible for this study. Mothers will fill out a questionnaire providing general medical and health information. For the ultrasound procedure, a transducer (a small, wand-like device) is moved across the belly to produce images of the fetus. When the baby is awake and swallowing, images of the mouth, throat and air passages will be recorded on videotape. The movements associated with feeding-breathing, sucking, yawning and swallowing-will then be measured to document how swallowing develops. When the baby is born, researchers will review the medical chart for any findings relevant to this study. One to 2 weeks after delivery, the mother will be interviewed by telephone about the baby's feeding skills. Follow-up visits at 4 and 8 weeks after the birth will include observation of the baby's sucking and swallowing and an ultrasound examination, in which the transducer is held under the baby's chin during swallowing. Babies who show signs of slow sucking or swallowing development will have a follow-up examination at ages 4 and 8 months. Follow-up visits at 4 and 8 months after the birth will include observation of the baby's sucking and swallowing and an ultrasound examination, in which the transducer is held under the baby's chin during swallowing.