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Pregnancy clinical trials

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NCT ID: NCT02811172 Completed - Obesity Clinical Trials

Behavior of Biomarkers During Pregnancy and Lactation Through a Biological Multi-paradigm Model: BECOME Study Protocol

BECOME
Start date: January 2017
Phase:
Study type: Observational

Background Despite of advances in research, at the moment, various points related to the physiology of gestation and the etiology of severe diseases that can be developed in the course of it remain unknown. One of those aspects is the behavior of biomarkers (triglycerides, prolactin, glucose and cholesterol) during pregnancy, which experience a gradual increase in their levels until they reach the peak of hypertriglyceridemia, a few days before delivery. Several studies have reported that biomarkers experience a higher elevation in diabetic and obese pregnant women and in those women who suffer preeclampsia. The description of their behavior in different population of pregnant women (healthy women and women at risk) would identify the relation of these with some of the alterations that occurs more frequently during pregnancy. Objective The aim of this study is to develop a multi-paradigm biological model of systems to determine triglyceride, prolactin, glucose and cholesterol levels during pregnancy and its relation with lactogenesis in healthy and risk pregnant women. Methods A prospective cohort study will take place with women during pregnancy and lactation. Participating women will be divided into two groups. One group will be integrated by healthy women and the other group by pregnant women with a risk medical history. The personal, family and a detailed medical history will be collected in each group. A study of all the variables which influence the level of the mentioned biomarkers (triglycerides, cholesterol, glucose and prolactin) will be done. The universe consists in 4,300 women, who constitute the historical average deliveries during the semester in the city of Granada (Spain). The sample collection will be made in medical office's pregnancy control in Granada's hospitals, in their respective health centers and during the second half of 2015. The sample will be stratified and probabilistic. Peculiarities of pregnant women will be taken into account when calculating the size of the study sample. This sample will be made up of 224 women who comply with the inclusion criteria and that have signed the informed consent. To achieve the project objectives an organization comprising six theoretical and practical phases enabling the scientific development of the project. During the first phase, the technical and administrative preparation of the project is constructed. Thereafter, the work is divided into two action areas which encompass the collection and data modeling. The creation of a biological multi-paradigm computer simulation model of the levels of biomarkers in different months of pregnancy and in the various pathologies of pregnant women can be very effective to know the risks that involve high levels of lipids for the mother and for the baby.

NCT ID: NCT02807493 Completed - Pregnancy Clinical Trials

Use of an Occlusal Support Device During the Second Stage of Labor

Start date: April 1, 2017
Phase: N/A
Study type: Interventional

The primary objectives of this study are to determine if the use of an Occlusal Support Device (OSD)(Mouthguard) can reduce the duration and intensity of the second stage of labor, reduce the incidence of labor complications including Caesarian Sections and improve Apgar scores in newborns

NCT ID: NCT02807324 Recruiting - Pregnancy Clinical Trials

Women Specific Cardiac Recovery After Preeclampsia

WeCare
Start date: June 2016
Phase:
Study type: Observational

Pregnancy is considered a cardiovascular (CV) stress test, and complicated pregnancies are associated with an increased risk for cardiovascular disease (CVD) later in life. Moreover, it is known that often the pregnancy induced CV adaptation does not resolve completely after a short postpartum (PP) period and it is not clear whether these induced changes will resolve over a longer period of time (i.e. in the upcoming months/years after delivery). Understanding the cardiac adaptation during pregnancy and the reversal process in the postpartum period, as well as the factors that influence this these processes, may provide us not only insight in this mechanism, but may help us in identifying factors that may be target points for modification.

NCT ID: NCT02804152 Completed - Pain Clinical Trials

Program for Pain & Prescription Opioid Use in Pregnancy

Start date: July 2016
Phase: N/A
Study type: Interventional

Pregnant women using prescription opioid medication (pain medications) are invited to take part in a program for the reduction of pain and prescription opioid misuse.

NCT ID: NCT02801695 Completed - Pregnancy Clinical Trials

Evaluation of the Efficacy of Citrulline Supplementation on the Delay of Delivery for Women Hospitalized for Pre-eclampsia (CITRUPE)

CITRUPE
Start date: February 20, 2017
Phase: Phase 2/Phase 3
Study type: Interventional

Pre-eclampsia (PE) complicates 2-8 % of pregnancies and is associated with high maternal and fetal morbidity and mortality. The early clinical manifestations are the occurrence of a maternal blood pressure and proteinuria. Placental dysfunction impairs the nutrient supply to the fetus, and may be the cause of an intrauterine growth retardation (IUGR). This is a disease that causes prematurity and currently the only known cure is delivery of the placenta. Nitrogen monoxide (NO) regulates the placental blood flow. However, pre-eclampsia is directly related to a failure of placental NO production. In this context, several clinical trials have tested the effect of NO donors such as L- arginine. However, supplementation with L -Arginine in a randomized trial in Nantes, has proved to be ineffective in severe vascular IUGR. Citrulline is a natural aminoacid precursor to arginine and in contrast to L-arginine escapes uptake in the liver and appears directly in the peripheral blood converted by the kidney in arginine, released into the systemic circulation, Citrulline may therefore be more effective in the treatment of pre-eclampsia. This prospective, randomized, comparative and double-blinded study aims to prolong pregnancy for patients with pre-eclampsia before 36 weeks.

NCT ID: NCT02800109 Completed - Pregnancy Clinical Trials

Child Follow-up Until 2 Years

Start date: May 2016
Phase:
Study type: Observational

The purpose of this study is to measure the impact of maternal malaria on child growth in the two first years of life in relation to fetal growth. This study is following a birth cohort of children born to pregnant women enrolled in the study "Impact of malaria infection in pregnancy on fetal and newborn growth" (protocol OXTREC 14 08 and Mahidol 2009-003-01). In this cohort growth monitoring is conducted until 2 years of age using routine anthropometric measurements such as weight, length, arm and head circumference. A few additional tests will enhance the sensitivity of the study outcomes with minimal risk. These tests will include anthropometry, screening, nutrition questionnaire and neurodevelopmental assessment. This study was funded by Wellcome Trust core funding, grant ref. number Wellcome Trust Major Overseas Program Grant no. 220211 (2020-2025)

NCT ID: NCT02797990 Completed - Pregnancy Clinical Trials

Conflict Between Maternal Autonomy and Child Health in Substance-use

Start date: May 2016
Phase: N/A
Study type: Observational

Qualitative project, comprising open-ended semi-structured interviews with healthcare workers, who provide antenatal care to substance-using women.

NCT ID: NCT02797860 Completed - Pregnancy Clinical Trials

Comparison of Onset and Duration of Rocuronium Between 2nd Trimester Pregnant and Non-pregnant Women

Start date: June 2016
Phase:
Study type: Observational

Pregnancy is associated with major changes of the body's physiological status and composition. These changes may modify the pharmacologic and/or pharmacokinetic profile of some drugs. Pharmacodynamic and pharmacokinetic changes in the 1st trimester during pregnancy are attributed to the following factors; Increase in plasma volume, heart rate and cardiac output; decrease in blood pressure due to decrease of systemic resistance and relative decrease of hepatic circulation and the aggravation of hepatic dysfunction. These changes intensify as pregnancy progresses into the 3rd trimester and take their effect on the onset time and duration of muscle relaxants. Rocuronium and the steroidal non-depolarizing muscle relaxant like vecuronium is mostly excreted with bile by hepatic metabolism and classified as the FDA pregnancy category B, and is widely used in general anesthesia of pregnant women. Previous studies reported onset time of rocuronium is affected by cardiac output, blood circulation time of the whole body, and muscle perfusion. Accordingly, many researches were conducted under the assumption of onset time and duration being affected by physiologic changes during pregnancy. For example, in the research where vecuronium was used as muscle relaxant for pregnant woman undergoing C-sec, onset of vecuronium was significantly shorter than that of the control group and duration was longer. In a study investigating rocuronium used for patients right after delivery, onset time was shorter and duration was longer than that of the control group. However, previous research mostly focused on the 3rd trimester, while there have been only a few studies of onset time and duration of rocuronium in non-obstetric surgery such as the transabdominal cervicoisthmic cerclage (TCIC) or Mcdonald surgery which are performed under general anesthesia during 2nd trimester. In this research, onset time and duration of rocuronium, which is widely used for general anesthesia in 2nd trimester pregnant females, will be compared with those of patients in the control group.

NCT ID: NCT02797327 Completed - Pregnancy Clinical Trials

Molecular Signature Pregnancy

MSP
Start date: September 12, 2016
Phase:
Study type: Observational

The primary goal of the study is to identify biomarkers from the molecular signature predictive of pre-term birth. This will be achieved through high frequency sampling and profiling throughout pregnancy.

NCT ID: NCT02796456 Completed - Obesity Clinical Trials

Determination of Maternal and Neonatal Apelinemia in Obese Women During Pregnancy

OB-APE
Start date: April 2016
Phase:
Study type: Observational

Background : Apelin and its receptor APJ have been implicated in pathologies including cardiovascular disease, diabetes and obesity. Little is known about the function of the apelinergic system during gestation. Objective : The main objective of this study is to compare apelinemia in fasting normal weight and obese women at the end of pregnancy, between 35 and 41 weeks of gestation (WG). Strategy and method: A prospective research evaluating will be conducted to compare apelinemia in fasting normal weight and obese women at the end of pregnancy, between 35 and 41 weeks of gestation (WG). A third group will be created to check if gestational diabetes is not a confounding factor in obesity (group of obese women with gestational diabetes). Investigators will try to see if apelinemia is correlated to lipidic and glycemic markers. Samples will be collected in the cord blood to compare maternal and neonatal apelinemia and to see if neonatal apelinemia is correlated to the child's weight and birth size and to the weight of the placenta. Placenta samples will be collected and RT-qPCR will be done to analyze RNA in each group. Two days after delivery, obese and not obese women will be fasted and plasma and colostrum will be collected. Investigators will compare apelin levels in the colostrum between these 2 groups and then investigators will try to see if apelin level is correlated in the colostrum and in maternal plasma.