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Pregnancy Complications clinical trials

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NCT ID: NCT02617927 Recruiting - Clinical trials for Pregnancy Complications

The Safety Assessment of Vedolizumab During Pregnancy in IBD Patient

Start date: October 2015
Phase:
Study type: Observational [Patient Registry]

The safety assessment of Vedolizumab during pregnancy in IBD patients. The primary objective of this study is: 1. To quantify incidence of major structural birth defects and other birth outcomes in infants born to women with UC/CD with exposure to Entyvio compared to women with exposure to other biological agents or conventional IBD therapy during pregnancy 2. To assess the health and developmental status of infants up to 1yr of age.

NCT ID: NCT02603913 Recruiting - Clinical trials for Endothelial Dysfunction

Oxidative Stress and Endothelial Function in Pregnancy Complications

ENDOPREG
Start date: November 2015
Phase: N/A
Study type: Observational

Pregnancy complications like pre-eclampsia (PE), pregnancy induced hypertension (PIH), intra-uterine growth restriction (IUGR) and preterm labor (PTL), (i.e. the major part of complications in pregnancy) are related to an impaired endothelial function. Endothelial dysfunction accounts for altered vascular reactivity, activation of the coagulation cascade and loss of vascular integrity. Nitric oxide (NO), a free radical molecule derived from L-Arginine by NOS (Nitric Oxide Synthase), is an endogenous endothelium-derived relaxing factor influencing endothelial function. In the placental circulation, endothelial release of NO dilates the fetal placental vascular bed and thus ensures feto-maternal exchange. The impaired endothelial function in pregnancy complications originates from production of inflammatory and cytotoxic factors by the ischemic placenta and results in oxidative stress and an altered bioavailability of NO. Measurement of endothelial function using peripheral artery tonometry and determination of ROS (reactive oxygen species) and RNS (reactive nitrogen species) using Electron Paramagnetic Resonance (EPR) gives an idea of the oxidative stress that took place and the degree of endothelial dysfunction that occurred during pregnancy.

NCT ID: NCT02558725 Recruiting - Clinical trials for Pregnancy Complications, Hematologic

Iron Supplementation During Pregnancy - One Versus Two Ferrous Sulfate Capsules for Iron Deficient Pregnant Women

Start date: April 2015
Phase: N/A
Study type: Interventional

Since normal pregnancies are associated with dilutional anemia, due to a greater increase in plasma volume with a smaller increase in RBC mass, it is important to properly diagnose IDA according to the levels of serum ferritin. Previous studies examining the optimal iron dose have shown that adjustment of iron supplementation according to serum ferritin levels in early pregnancy could be beneficial. Nonetheless, there is no consensus regarding the appropriate dose of iron during pregnancy, its dose-response curve and its effect on serum ferritin levels. In this trial the investigators sought to assess the efficacy of doubling the daily iron supplement dose in pregnant women with IDA.

NCT ID: NCT02480478 Recruiting - Clinical trials for Intrahepatic Cholestasis of Pregnancy

Serum Autotaxin Levels in Cholestasis of Pregnancy

Start date: June 2015
Phase: N/A
Study type: Observational

Intrahepatic cholestasis of pregnancy is the most common liver disease in pregnancy. It is is a pregnancy-specific liver disorder with onset mainly in the third trimester of pregnancy. ICP is characterized by pruritus, elevated serum fasting bile salts and transaminases and an increased risk of adverse fetal outcomes. Serum autotaxin levels were found highly sensitive and specific biomarker to to differentiate ICP from other pregnancy-related liver disorders or pruritic dermatoses. The purpose of the study is to determine the diagnostic accuracy of serum autotaxin activity in cholestasis of pregnancy.

NCT ID: NCT02385461 Recruiting - Clinical trials for Pregnancy Complications

Study on Antithrombotic Prevention in Thrombophilia and Pregnancy Loss

OTTILIA
Start date: January 2012
Phase:
Study type: Observational [Patient Registry]

The occurrence of a spontaneous fetal loss (FL) is a rather frequent event: it has been estimated that up to 15% of pregnancies result in a fetal loss. However, recurrent events, defined as >2 or >3 loss, depending on the guidelines used (American College of Obstetricians and Gynecologists or Royal College of Obstetricians Gynaecologists guidelines), occur in 1 % of all pregnancies and it is noteworthy that Recurrent Fetal Loss ( RFL) in about 30-40% of cases remain unexplained after standard gynaecological, hormonal and karyotype investigations. Furthermore, it is important to consider that chromosomal abnormalities are responsible for at least 60% of FL in the first trimester, thus an abnormal karyotype in the fetus should be excluded prior to consider testing women for genetic susceptibility to placental vascular complications (inherited thrombophilia). Common inherited conditions, the factor V Leiden (FV) and the factor II G20210A (FII) mutations have been recognized as risk factors for FL. The efficacy of treatment with antithrombotic drugs during pregnancy in women with a history of RFL/ Intra Uterine Fetal Death (IUFD) and thrombophilia is still debated, due to scarcity of available data. Italian guidelines suggest the use of Low-Molecular-Weight Heparin (LMWH) in women with FV or FII mutations and previous otherwise unexplained obstetric complications, while guidelines released by RCOG suggest that heparin therapy during pregnancy may improve the live birth rate in women with second trimester loss associated with inherited thrombophilias. Hence, the idea to propose this prospective observational study comparing clinical data and outcomes in women with common inherited thrombophilias and in women without. During this study the investigators will collect and evaluate clinical data from examinations and visits by patients, eligible for the study as carriers of thrombophilic defects. This observation will begin before pregnancy and continue until the puerperium, allowing us to study all possible factors influencing these conditions. The study will add knowledge for improving feto-maternal prognosis and preventing spontaneous and recurrent FL. Plan of the study: multicenter observational study

NCT ID: NCT02372487 Recruiting - Clinical trials for Pregnancy Complication

Sildenafil Citrate Therapy for Oligohydramnios

Start date: March 2015
Phase: N/A
Study type: Interventional

The aim of this randomized trial is to detect whether or not the use of Sildenafil citrate therapy will increase the amniotic fluid volume expressed in term of amniotic fluid index measured via ultrasound for fetuses of pregnancies complicated by oligohydramnios, and to compare the outcomes of Sildenafil-treated pregnancies with similar pregnancies that will remain Sildenafil-naïve.

NCT ID: NCT02356744 Recruiting - Clinical trials for Pregnancy, Complications

Maternal and Neonatal Outcome in Pregnant Women Before and After 1 Year Since Bariatric Operation

Start date: February 2, 2016
Phase: N/A
Study type: Observational

Ultrasound follow up for 9 months pregnancy in women underwent baraitric surgery before and after 1 year of surgery.

NCT ID: NCT02275507 Recruiting - Clinical trials for Complications of Pregnancy, Childbirth and the Puerperium

Non-Invasive Hemoglobin Monitoring of Women Undergoing Cesarean Delivery

Start date: October 2014
Phase: N/A
Study type: Observational

The purpose of this study is to determine the normal hemoglobin curve during cesarean delivery and for the first 24 hours after surgery to aid in the creation of an algorithm to detect life-threatening bleeding earlier.

NCT ID: NCT02021864 Recruiting - Clinical trials for Pregnancy Complications

Vitamin D Treatment and Hypocalcemic Pregnant Women

Start date: January 2014
Phase: N/A
Study type: Interventional

- Pregnant women in 24-26 gestational week will be recruited.Serum calcium and 25(OH)D will be evaluated and women with mild hypocalcemia (serum calcium 8-8.6 mg/dl) and 25(OH)D less than 30ng/ml will be entered to study. . - Excluding criteria are: gestational diabetes or diabetes before pregnancy, severe preeclampsia, chronic hypertension, fetal anomaly, oligohydramnios or polyhydramnios, parathyroid disorders, hepatic or renal diseases, malnutrition , use of anti- convulsive and immunosuppressive drugs. - Participants will randomly assigned in to two groups of intervention and control groups .Randomization will be done by random number generator. Intervention group will receive weekly vitamin D3, 50,000 unit for 8 weeks plus daily prenatal multivitamin containing elemental calcium 250 mg/day and vitamin D3 400 unit , control group will receive daily prenatal multivitamin. - At the time of delivery, serum calcium, 25(OH)D of mothers, maternal weight gain during study , Serum calcium and 25(OH)D of newborns and neonatal growth indices ( length, weight, head circumference ) will be compared between two groups.

NCT ID: NCT01988168 Recruiting - Clinical trials for Postoperative Complications

Closure of Skin in ChorioAmnionitis Research Pilot Study

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

The purpose of the CSCAR pilot study is to improve the design of a full-scale trial by determining the patient recruitment rate and participation rate. The objective of the full-scale trial is to determine the optimal method of skin closure after Caesarean delivery in women with chorioamnionitis, which is an acute inflammation of the membranes and chorion of the placenta, seen typically after rupture of membranes with ascending polymicrobial bacterial infection. Women in labour with chorioamnionitis will be randomized at the time of Caesarean delivery to skin closure with either staples or sutures. The women will be followed at 6 weeks and 6 months post-partum in order to establish the occurrence of surgical site infection and wound disruption, as well as evaluation of the scar and other secondary questions. The investigators hypothesis is that closure of skin with sutures will have a rate of wound infection that is no higher than the rate of wound infection when closing skin with staples. The investigators also hypothesize that closure with sutures will have a decreased rate of wound disruption, increased patient satisfaction and decreased length of hospital stay compared to skin closure with staples.