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Pregnancy clinical trials

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NCT ID: NCT01360060 Completed - Pregnancy Clinical Trials

Analgesia After Cesarean Section

Start date: December 2010
Phase: N/A
Study type: Observational

Magnesium sulphate is the first line therapy for the management of preeclampsia and eclampsia in obstetrics. Perioperative administration of magnesium sulphate has been proved to be an effective as an analgesic adjuvant. The investigators evaluated the analgesic effect of magnesium in parturients undergoing Cesarean section.

NCT ID: NCT01351428 Completed - Hypertension Clinical Trials

Goal-Directed Therapy in Pregnant Women at High Risk of Developing Preeclampsia

Start date: December 2010
Phase: N/A
Study type: Interventional

Preeclampsia is associated with significant maternal and fetal morbidity and mortality. Early identification and subsequent management of patients at risk of developing preeclampsia presents an ongoing challenge in prenatal care. Some at risk pregnancies may be identified from: - serum screening abnormalities in the first or second trimester - placental shape and texture at the 18-20 anatomical ultrasound - uterine artery blood flow. Early identification and effective treatment of patients would permit the safe completion of the pregnancy for the mother and infant. Recent advances in non-invasive cardiovascular monitoring have enabled the study of maternal hemodynamics in normal and at-risk pregnancies. This study hopes to identify the earliest significant changes in maternal hemodynamics which may allow targeted therapeutic interventions in patients at high risk of developing preeclampsia. The hypothesis of this study is that systemic vascular resistance rises during the pre-clinical phase of preeclampsia and this can be captured using non invasive bioreactance technology. Treatment of the abnormally high vascular tone may decrease the severity and postpone the onset of clinical disease.

NCT ID: NCT01346527 Completed - Type 2 Diabetes Clinical Trials

Fat Metabolism in Pregnancy and Neonatal Heart Function in Diabetes

Start date: April 2011
Phase:
Study type: Observational

Background: The health of the next generation is likely programmed in the womb (i.e.in utero), and our understanding of how that programming happens will allow us to favorably influence the health of future generations. The focus of this proposal is to examine the effect of in utero programming on heart function in children born to women with type 2 diabetes (T2DM). Specifically, neonates born to diabetic women have abnormal heart structure and weaker heart function at birth, which may predispose them to long-term heart problems in childhood, adolescence and adulthood. At present, the reason for these heart abnormalities in children born to women with diabetes is unknown and is the focus of this proposal. Objective(s) and Hypothesis(es): The objectives are to examine the relationships among maternal lipid (fatty acid, triglyceride, very low density lipoprotein) metabolism and neonatal heart structure and function in diabetes and to identify clinical markers during pregnancy for heart dysfunction in infants born to diabetic women. The overall hypothesis is that maternal lipid metabolism is abnormal in diabetes, and this metabolic dysregulation increases fatty acid delivery to the fetus in utero and leads to abnormal accumulation of lipid in the fetal heart, resulting in altered neonatal heart structure and function in infants born to diabetic women. In addition, the investigators hypothesize that decreased maternal fatty acid oxidation (fat "burning") rate, elevated lipolytic (fat breakdown) rate and elevated blood total free fatty acid level predicts abnormal neonatal heart structure and function in infants born to women with type 2 diabetes. Methods and Procedures: The investigators will test these hypotheses by using clinical metabolism studies (infusion of stable isotope labeled fatty acid, serial blood and breath sampling, and mass spectrometry) to quantify whole-body fat (fatty acid oxidation, lipolysis, and serum fatty acid , triglycerides, VLDL-cholesterol levels) metabolism in 25 diabetic women during the 3rd trimester of pregnancy, and compare these lipid metabolism kinetics to 25 body mass index matched healthy non-diabetic women during pregnancy and determine if alterations in maternal lipid metabolism predict abnormal neonatal heart function in children born to these women. Potential Impact: Type 2 diabetes is an epidemic in the United States and is steadily increasing worldwide. Diabetes has detrimental health effects in pregnant women and in their offspring. The investigators know that children born to women with diabetes have an increased risk for developing diabetes, obesity and cardiovascular disease, than children born to healthy women. This proposal will address an important knowledge gap regarding the role of maternal lipid (and potentially other nutrients) metabolism on the cardiovascular health of the global and increasing population of children born to diabetic women. Findings from this project will be novel and innovative, and will likely point to clinical interventions that target and correct lipid and other metabolic abnormalities in women with pre-gestational diabetes. The impact will be great because the long-term goal is to ameliorate heart problems in children born to diabetic (both pre-gestational and gestational) women. In addition, this project will establish a small cohort of children that can be followed long-term to address novel questions about the progression of heart and other metabolic abnormalities in children born to diabetic women.

NCT ID: NCT01322529 Completed - Pregnancy Clinical Trials

Nulliparous Pregnancy Outcomes Study: Monitoring Mothers-to-be

nuMoM2b
Start date: September 2010
Phase: N/A
Study type: Observational

Forty percent of pregnant women in the United States are women who have never given birth. As a group, they sometimes have complications with their pregnancy, but there is no information from a previous pregnancy to identify who might have a problem. Very little research has been done with this group. The Nulliparous Pregnancy Outcomes Study: Monitoring Mothers-to-be (nuMoM2b) is collecting data from a diverse population of about 10,000 women who are having their first baby and are carrying only one baby. The women are enrolled early in pregnancy and undergo research assessments four times during their pregnancies. Data are collected through interviews, self-completed data forms, clinical measurements, ultrasound, and collection and storage of blood samples, urine samples, and fluid from the vagina and cervix. Some information comes from medical records. A subset of women may be asked to participate in substudies collecting information on sleep breathing, sleep patterns and quality, or other areas possibly related to birth outcomes. The goal of the research is to find ways to identify women in this group who might develop a problem with their pregnancy and use this information to improve the health of pregnant women and their babies in the future. The study is focusing on pregnancy problems like high blood pressure, babies that are born much too early and very small babies.

NCT ID: NCT01321710 Completed - Pregnancy Clinical Trials

Sleep Disruption in New Mothers: An Intervention Trial

MOMS
Start date: December 2004
Phase: N/A
Study type: Interventional

The purpose of this study is to test a behavioral intervention to minimize sleep disruption and fatigue in new mothers after the birth of their first infant. This study also tests whether an acetaminophen intervention at the time of an infant's 2-month immunization series improves infant and maternal sleep.

NCT ID: NCT01318304 Completed - HIV Clinical Trials

Vaginal Innate Immunity in Normal and HIV-Infected Women

Start date: October 2010
Phase: N/A
Study type: Observational

The innate immunity of the vaginal tract provides first-line defense from abnormal microorganisms or overgrowth of common organisms, such as Candida species or Gardnerella vaginalis. It is unclear from the current available literature whether the rate of vaginal infection increases or decreases in frequency during pregnancy when compared to the non-pregnant state, but this may be predicted by shifts in vaginal innate immunity. Vaginal infections are important players in HIV disease, potentially increasing the risk of viral transmission. In addition, these infections may activate inflammatory markers in the reproductive tract and increase the risk of premature delivery or other negative pregnancy outcomes. The vaginal innate immune system has not been well characterized in pregnant women, or in women with HIV infection. The study of how this system changes in pregnancy and HIV infection will provide essential knowledge for further study of vaginal mucosal protection. The investigators study is an observational study designed to compare levels of vaginal innate immunity markers in women based on a) pregnancy status and b) HIV infection status. Comparisons will be made between pregnant and non- pregnant women and between HIV positive and HIV negative women. The investigators hypothesize that there will be significant differences in levels of innate immunity between the groups.

NCT ID: NCT01315860 Completed - Pregnancy Clinical Trials

Association of Biomechanical Changes and Weight Gain Throughout Pregnancy

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

Low back and posterior pelvic pain are common in pregnant females. Previous studies have demonstrated disability and it is estimated that all women experience some degree of musculoskeletal discomfort during pregnancy. Borg-Stein et. al. found 25% of pregnant females have temporarily disabling symptoms. There is demonstrated controversy over the mechanism of low back pain in pregnancy. The biomechanical theory implies that the enlarging uterus causes the maternal center of gravity to move anteriorly causing stress on the low back. Jensen et. al. demonstrated that weight gain correlated with biomechanical changes. The changes were measured by weight gain in segmental regions of the body and in principal moments of inertia from the sit to stand movement. Literature does not demonstrate a specific correlation between weight gain and the biomechanical changes of sway rate, lumbosacral angle and center of gravity. These three measurements may have a correlating effect on the underlying cause of low back pain in pregnant women. This study aims to determine the correlation between weight gain of pregnant females and the biomechanical changes of sway rate, lumbosacral angle and center of gravity. The change in weight over the last two trimesters will be correlated with the sway rate, lumbosacral angle and center of gravity. The degree of symptomatic low back pain as measured by the Oswestry Low Back Pain Scale will also be correlated with the sway rate, lumbosacral angle and center of gravity.

NCT ID: NCT01303575 Completed - HIV Infections Clinical Trials

Internet-Based Sexual Health Education for Middle School Native American Youth

IYG-AI/AN
Start date: September 2010
Phase: N/A
Study type: Interventional

This study will evaluate the effect of an American Indian/Alaska Native (AI/AN) adaptation of the It's Your Gameā€¦Keep It Real (IYG) intervention, relative to a comparison condition on sexual behavior outcomes and psychosocial variables for middle school aged youth (12 - 14 years old). The original IYG program was designed for students in Houston middle schools to help students delay sexual initiation and if sexually active, use condoms and contraception. The present study will adapt the existing IYG program for an AI/AN youth cohort; the original IYG curriculum will be transferred into a web-based format and modified to incorporate additional culturally-relevant components. The primary hypothesis to be tested is: (1) students who receive the web-based curriculum will delay sexual activity relative to those who receive standard care. The major dependent variable is the proportion of students initiating sexual activity. Secondary hypotheses will examine the effect of the web-based curriculum on specific types of sex and psychosocial variables related to sexual risk-taking behavior. This project will also examine the effect of the intervention on the proportion of students who are sexually active, number of times students engage in unprotected sexual intercourse, and students' number of sexual partners.

NCT ID: NCT01291342 Completed - Clinical trials for Uremia in Pregnancy Without Hypertension

Detection and Identification of Preeclampsia Via Volatile Biomarkers

DIP
Start date: September 2011
Phase: N/A
Study type: Observational

Preeclampsia is a form of hypertension that is unique to human pregnancy. The incidence of the disease ranges between 2 and 7 percent in healthy nulliparous women. The etiology of preeclampsia is unknown. Women with preeclampsia may exhibit a symptom complex ranging from minimal BP elevation to derangements of multiple organ systems. The renal, hematologic, and hepatic systems are most likely to be involved. More than 100 clinical, biophysical, and biochemical tests have been recommended to predict or identify the patient at risk for the future development of the disease. The results of the pooled data for the various tests and the lack of agreement between serial tests suggest that none of these clinical tests is sufficiently reliable for use as a screening test in clinical practice. As a result there is obviously a great need to develop a novel technology for the early detection of this pregnancy complication before its clinical manifestations appear. An early detection can help in early treatment to prevent or at least minimize the sequel of this disease. The aim of this project is the early detection of "Preeclampsia" and other pregnancy complications using volatile biomarkers appearing in exhaled breath and/or blood samples, using a simple and inexpensive toll termed NA-NOSE. Phase-I: The primary phase of this project is the comparison between volatile biomarkers' patterns of pregnant women suffering from "Preeclampsia", pregnant women that are considered to have "Normal Pregnancy", and healthy "Non-Pregnant" women. Phase-II: The secondary phase of this project is the ability to predict "Preeclampsia", as compared, head-to-head, with other potential predictors used in the current clinical practice.

NCT ID: NCT01279486 Completed - Pregnancy Clinical Trials

Clearblue Home Pregnancy Test Consumer Study

Start date: December 2010
Phase:
Study type: Observational

Approximately 120 female volunteers requesting a pregnancy test will be recruited locally to the UK trial centre. Volunteers will be required to use the Clearblue Pregnancy Test according to the product instructions, and provide a urine sample from the same void. Trained technicians will conduct a second test from the urine sample.