Endothelial Dysfunction in Hyperemesis Gravidarum

Hyperemesis; Gravidarum, With Dehydration Clinical Trial

Official title:

Endothelial Dysfunction in Hyperemesis Gravidarum

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02989337
• Other study ID #: 2016/579
• Status: Recruiting
• Phase: N/A
• First received: December 8, 2016
• Last updated: December 8, 2016
• Start date: December 2016
• Est. completion date: March 2017

Study information

• Verified date: December 2016
• Source: Kayseri Education and Research Hospital
• Contact: Erdem SAHIN, Principal Investigator
• Phone: +905321688683
• Email: erdemsahin07[@]hotmail.com
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: March 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Dehydration
• Hyperemesis Gravidarum
• Hyperemesis; Gravidarum, With Dehydration

Locations

Country	Name	City	State
Turkey	Kayseri Training and Research Hospital	Kayseri

Sponsors (1)

Lead Sponsor	Collaborator
Kayseri Education and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum inflammatory adhesion molecules in hyperemesis gravidarum		4 months	No