Clinical trial NCT02989337: Endothelial Dysfunction in Hyperemesis Gravidarum
Official title: Endothelial Dysfunction in Hyperemesis Gravidarum
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hyperemesis; Gravidarum, With Dehydration
Keywords: Hyperemesis Gravidarum
Inflammatory adhesion molecules
Dehydration
Lead sponsor: Kayseri Education and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2016-12-12
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
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.

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Serum inflammatory adhesion molecules in hyperemesis gravidarum
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Kayseri
country: Turkey
facility: Kayseri Training and Research Hospital
Study officials:
affiliation: Kayseri Training and Research Hospital
name: Erdem SAHİN
role: PRINCIPAL_INVESTIGATOR
References: