Endothelial Dysfunction in Hyperemesis Gravidarum

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

Study Overview

• Status: Unknown
• Conditions: Hyperemesis; Gravidarum, With Dehydration

Detailed Description

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 The 2mL of blood samples were withdrawn into serum-separating tubes for the measurements of serum biochemical parameters and 2 mL blood samples were withdrawn into EDTA containing tubes for measurement serum hemoglobin and hematocrit levels.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 In addition 2mL of blood samples were withdrawn into serum-separating tubes for analyzing serum sVEGFR-1, sVCAM-1, sE-selectin and sICAM-1 levels.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.

• Study Type: Observational
• Enrollment (Anticipated): 50

Contacts and Locations

• Study Contact: Name: Yusuf MADENDAG, Central Contact Backup; Phone Number: +905055011340; Email: yusufmadendag@gmail.com

Study Locations

• Turkey
  • Kayseri, Turkey, 38000
    • Recruiting
    • Kayseri Training and Research Hospital
    • Contact: yusuf madendag; Phone Number: +905055011340; Email: yusufmadedag@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

Other pathologies causing nausea and vomiting;

• gastroenteritis
• gastroparesis
• gall duct diseases
• hepatitis
• peptic ulcers
• appendicitis
• pyelonephritis
• urinary tract stones
• hyperthyroidism
• hyperparathyroidism
• migraine
• vestibular diseases

Patients were excluded from the study in the presence of parameters that may cause endothelial dysfunction such as;

• 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
• surgery within the last month

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
hyperemesis gravidarum with dehydration; The first group was formed of the patients diagnosed hyperemesis gravidarum with dehydration
Control group; The control group was formed of the patients who were healthy pregnant women admitted to the clinic just for routine examination without any symptoms

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Serum inflammatory adhesion molecules in hyperemesis gravidarum	4 months

Collaborators and Investigators

• Sponsor: Kayseri Education and Research Hospital

Study record dates

Study Major Dates

• Study Start: December 1, 2016
• Primary Completion (ANTICIPATED): March 1, 2017
• Study Completion (ANTICIPATED): March 1, 2017

Study Registration Dates

• First Submitted: December 8, 2016
• First Submitted That Met QC Criteria: December 8, 2016
• First Posted (ESTIMATE): December 12, 2016

Study Record Updates

• Last Update Posted (ESTIMATE): December 12, 2016
• Last Update Submitted That Met QC Criteria: December 8, 2016
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Keywords: Dehydration; Hyperemesis Gravidarum; Inflammatory adhesion molecules
• Additional Relevant MeSH Terms: Pathologic Processes; Metabolic Diseases; Signs and Symptoms, Digestive; Pregnancy Complications; Water-Electrolyte Imbalance; Morning Sickness; Vomiting; Dehydration; Hyperemesis Gravidarum
• Other Study ID Numbers: 2016/579