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临床试验/NCT02989337
NCT02989337
Unknown
不适用

Endothelial Dysfunction in Hyperemesis Gravidarum

Kayseri Education and Research Hospital1 个研究点 分布在 1 个国家目标入组 50 人2016年12月

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
Hyperemesis; Gravidarum, With Dehydration
发起方
Kayseri Education and Research Hospital
入组人数
50
试验地点
1
主要终点
Serum inflammatory adhesion molecules in hyperemesis gravidarum
最后更新
9年前

概览

简要总结

The purpose of the study is to determine serum inflammatory adhesion molecules levels in hyperemesis gravidarum

详细描述

The study population consisted of 2 groups; (1) the hyperemesis gravidarum group, consist of 25 pregnant women who developed dehydration due to HG between 6 and 13 gestational weeks and between 18 and 35 years (2) the normal pregnancy group, consisting of 25 pregnant women. HG was defined according to the fallowing American College of Obstetricians and Gynecologists (ACOG) criteria; severe nausea and vomiting resulted in 5% weight loss with regard to pre-gestation or vomiting more than 3 times and 3-5 % weight loss with ketonuria. The diagnosis of dehydration was clinically defined and patients with moderate and severe dehydration were included in the study. As clinical findings; Weight loss, capillary recall time, dry mucous membranes, dry eye, pulse rate, systolic blood pressure, respiration, skin turgor deterioration and urine output were evaluated. Other pathologies causing nausea and vomiting like; gastroenteritis, gastroparesis, gall duct diseases, hepatitis, peptic ulcers, appendicitis, pyelonephritis, ovarian torsion, urinary tract stones, diabetic ketoacidosis, hyperthyroidism, hyperparathyroidism, migraine, pseudo tumor cerebra, vestibular diseases were excluded from the study.Patients were excluded from the study in the presence of pregestational diabetes chronic hypertension, chronic liver and renal failure, preeclampsia history, multiple pregnancy, hyperlipidemia, hypercholesterolemia, obesity, tobacco use, NSAID drug use, infection within the last three months and surgery within the last month that could cause endothelial dysfunction. Blood and urine specimens were collected from the patients with HG during hospitalization and during regular clinic visits in control group. The 2mL of blood samples were withdrawn into serum-separating tubes for the measurements of serum biochemical parameters and 2 mL blood samples were withdrawn into EDTA containing tubes for measurement serum hemoglobin and hematocrit levels. Early-morning urine samples were collected from study population. These blood and urine samples were analyzed in same day for Kayseri Education and Research hospital biochemical clinics. In addition 2mL of blood samples were withdrawn into serum-separating tubes for analyzing serum sVEGFR-1, sVCAM-1, sE-selectin and sICAM-1 levels. All of the serum were stored at -80°C in nonadsorbable tubes. After three months for stored first blood sample, serum sVEGFR-1, sVCAM-1, sE-selectin and sICAM-1 levels were determined by an enzyme linked immunosorbent assay.

注册库
clinicaltrials.gov
开始日期
2016年12月
结束日期
2017年3月
最后更新
9年前
研究类型
Observational
性别
Female

研究者

发起方
Kayseri Education and Research Hospital
责任方
Principal Investigator
主要研究者

Erdem Sahin

Principal Investigator

Kayseri Education and Research Hospital

入排标准

入选标准

  • 6-13 gestational weeks
  • between 18-35 years of age
  • Single pregnancy
  • Dehydration due to HG

排除标准

  • Other pathologies causing nausea and vomiting;
  • gastroenteritis
  • gastroparesis
  • gall duct diseases
  • hepatitis
  • peptic ulcers
  • appendicitis
  • pyelonephritis
  • urinary tract stones
  • hyperthyroidism

结局指标

主要结局

Serum inflammatory adhesion molecules in hyperemesis gravidarum

时间窗: 4 months

研究点 (1)

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