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Pregnancy clinical trials

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NCT ID: NCT03375359 Recruiting - Pregnancy Clinical Trials

First Trimester Screening for Trisomy 21, 18, 13 and 22q11.2 Deletion Syndrome

ReFaPo02
Start date: January 8, 2018
Phase:
Study type: Observational

Combined first-trimester screening represents the gold standard of risk assessment for the presence of trisomy 21, 18, and 13. The concept is based on the age risk, the measurement of fetal nuchal translucency (NT), and the determination of serum markers free beta-hCG and PAPP-A in maternal blood. In recent years it has been shown that the risk assessment can be improved by combining in-depth ultrasound and cell-free DNA analysis from maternal blood. In their latest study, the investigators were able to detect all fetuses with trisomy 21, 18, and 13 through this procedure. No normal fetus displayed an increased risk. In contrast, the detection rate in classic, combined first-trimester screening is about 95% and the false-positive rate is 3-5%. In this study the investigator examine the test quality - especially the false positives - of cell-free DNA analysis on trisomy 21, 18 and 13 as well as on the microdeletion 22q in 1000 pregnancies.

NCT ID: NCT03364712 Completed - Pregnancy Clinical Trials

Maternal Serum BLyS Levels Throughout Pregnancy

Start date: September 19, 2011
Phase: N/A
Study type: Observational

Background and rationale: B lymphocyte stimulator (BLyS) is a potent B cell survival factor that has been found to be elevated in patients with inflammatory conditions, such as systemic lupus and rheumatoid arthritis. Because of the immunologic changes associated with pregnancy, including changes in levels of T and B lymphocytes, it is postulated that BLyS levels would be altered in pregnancy compared to the non-pregnant state. Objectives: The primary objective of this study is to assess the levels of BLyS in each trimester of pregnancy. Secondary objectives include evaluation of an association between BLyS levels and adverse pregnancy events; comparison of BLyS levels between healthy pregnant women and pregnant women with a medical or obstetric conditions; and, assessment of APRIL levels and comparison between APRIL levels and BLyS levels in study subjects. Study population: Pregnant and non-pregnant women receiving care in the outpatient Obstetrics and Gynecology clinics at LAC+USC Medical Center. Study methodology: Peripheral blood samples will be drawn from pregnant women and non-pregnant controls. Pregnant women will have blood drawn each trimester, at delivery, and postpartum, and control subjects will have blood drawn once, upon enrollment in the study. Study outcomes: BLyS and APRIL levels during each trimester, postpartum and in cord blood will be compared between healthy pregnant women, pregnant women with a medical condition, and healthy non-pregnant controls. Additionally, pregnancy outcomes will be recorded to determine whether BLyS or APRIL levels correlate with adverse events. Statistics: Continuous data will be analyzed by Student t-test or logistic regression, where appropriate. Categorical data will be analyzed using Chi square.

NCT ID: NCT03348332 Completed - Pregnancy Clinical Trials

Effect During Pregnancy and Intrapartum Health

Start date: March 2012
Phase: N/A
Study type: Interventional

Assessing the role of moderate exercise in newborn intrapartum variables have showed to be crucial not only on prescribing exercise safely, but also on understanding its impact on the prevention of some cardio-metabolic diseases after labor. Clarify this concept will be essential on reducing human risk for some chronic diseases through implementing supervised exercise programs during such a critical period.

NCT ID: NCT03343912 Completed - Pregnancy Clinical Trials

Estriol and Trimegestone Dose-response Trial With Single Dose Application of Vaginal Rings

Start date: November 10, 2017
Phase: Phase 1
Study type: Interventional

This clinical trial is performed as proof of pharmacological action investigation by demonstration of ovulation inhibition (dose-response study) under treatment with three Test vaginal rings releasing varying doses of estriol (E3) and trimegestone (TMG). Blood samples for determination of estradiol (E2) and progesterone (PG) levels will serve as pharmacodynamic surrogate parameters for characterization of the treatment effect on the endogenous hormones. Blood samples for determination of E3 and TMG in plasma will be collected in order to characterize pharmacokinetic parameters. Additionally, local tolerability characterized by gynecological inspection of the vaginal mucosa prior to and after insertion of the Investigational Medicinal Product (IMPs) is planned to be assessed

NCT ID: NCT03343431 Active, not recruiting - Pregnancy Clinical Trials

Antiviral Prophylaxis and Infant Vaccination to Prevent Perinatal Hepatitis B Infection

Start date: August 2, 2018
Phase: Phase 3
Study type: Interventional

Most new hepatitis B virus (HBV) infections are acquired perinatally. In this study, pregnant women with HBsAg and HBeAg will receive tenofovir disoproxil fumarate during the last trimester of pregnancy and for two months following delivery. Their infants will receive hepatitis B (HB) immunization, starting with a first dose soon after birth. We hypothesize that the risk of mother-to-child transmission of HBV will be lower than 2%. The results of the study will help define policy to manage HBV infected pregnant women to prevent perinatal transmission.

NCT ID: NCT03335293 Withdrawn - Pregnancy Clinical Trials

RCT of Epinephrine (None, 100mcg, and 200mcg) in a Hyperbaric Bupivacaine, Fentanyl and Morphine Spinal in C-sections.

Start date: October 2019
Phase: Phase 4
Study type: Interventional

This is a prospective, randomized, double blind study of 75 patients (n=25 for each group) in which epinephrine (100mcg or 200mcg) or normal saline vehicle is added to intrathecal hyperbaric bupivacaine (0.75% bupivacaine hydrochloride in 8.25% dextrose), fentanyl, and morphine to prolong the duration of the spinal anesthetic in scheduled cesarean deliveries. The primary outcome of duration will be the time to T10 level sensory regression as well as motor level regression that will be graded via the modified Bromage scale. Repeat cesarean sections, in particular, are associated with increased operative time and thus often performed with a spinal-epidural (CSE) technique. The epidural component is, however, untested and may not provide adequate anesthesia, thus the higher risk of conversion to a general anesthesia. Epinephrine is routinely used to prolong spinal anesthesia. If effective for the duration of a repeat cesarean section it would obviate the additional time and risks of performing the epidural and still avoid sufficient duration to avoid conversion to a general anesthetic.

NCT ID: NCT03330860 Completed - Pregnancy Clinical Trials

Effectiveness of 12 Clips in Maternal and Neoanatal Health Through Applied Neuroscience Tools (Neuromarketing Strategy)

Start date: November 16, 2015
Phase: N/A
Study type: Interventional

Objective: To evaluate the effectiveness of 12 knowledge transfer clips of maternal and neonatal health in order to generate knowledge appropriation. Methodology: Randomized cross-over clinical trial with a non-probabilistic sample of intentional feature of 150 subjects: pregnant women, non-pregnant women and men. Participants will be evaluated during the observation of 13 clips (one of them is the control clip) in which sequence will be assigned randomly. The level of attention will be assessed by means of eye tracking, to see the ocular gaze and fixation in relation to the content of clips, and emotional reaction through the psychophysiological record (galvanic skin response). In addition, recall of information will be assessed through the application of questionnaires at the end of each video. The analysis will focus on identifying differences in the three outcomes between intervention clips and the control clip, and between the three groups, and determine the clips and segments that generate greater emotional response, attention and recall.

NCT ID: NCT03318003 Completed - Pregnancy Clinical Trials

Auto-PAP Therapy For Improved Fetal Growth

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

The purpose of this study is to see whether the presence of night-time breathing disturbances ("sleep-disordered breathing") in pregnant women is related to fetal growth patterns. The hypothesis is that fetal growth slows in the 3rd trimester in women with sleep-disordered breathing. Use of a nighttime breathing therapy called auto-PAP could minimize the slowing in fetal growth.

NCT ID: NCT03315806 Completed - Pregnancy Clinical Trials

Pregnancy, Nitrate, Endothelial Function and Tissue Oxygen Saturation

Start date: October 6, 2016
Phase: N/A
Study type: Interventional

Adequate macro and microvascular endothelial function during pregnancy is essential for the normal placental development and growing fetus. Beetroot juice (BJ) promotes improvement ins this parameters in no-pregnant individuals, however the beneficial effect did not avaliated in pregnant. The present study evaluated effects of BJ on macro and microvascular endothelial function in pregnant. Twelve pregnant were submitted to BJ and nitrate-depleted juice (PLA) interventions. Brachial flow-mediated dilation (FMD) and muscle oxygenation were measured 120 min after interventions. Urinary nitrate, nitrite were measured at baseline and 120 min after interventions.

NCT ID: NCT03310853 Completed - Pregnancy Clinical Trials

The Effect of Probiotics on Maintenance of Health in Pregnancy and Infants

Start date: October 23, 2017
Phase: Phase 2
Study type: Interventional

This phase 2 study evaluates the effect of perinatal use of probiotics on the number of diagnosed viral, bacterial and fungal infections in pregnant women and on the maintenance of a health pregnancy. In addition, the effect of probiotics intake during pregnancy and breastfeeding on the infant's overall health status will be evaluated.