Endothelial Dysfunction in Hyperemesis Gravidarum

NCT ID: NCT02989337

Last Updated: 2016-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-12-31

Study Completion Date

2017-03-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Hyperemesis; Gravidarum, With Dehydration

Keywords

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Hyperemesis Gravidarum Inflammatory adhesion molecules Dehydration

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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hyperemesis gravidarum with dehydration

The first group was formed of the patients diagnosed hyperemesis gravidarum with dehydration

No interventions assigned to this group

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

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Kayseri Education and Research Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Erdem Sahin

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Erdem SAHİN

Role: PRINCIPAL_INVESTIGATOR

Kayseri Training and Research Hospital

Locations

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Kayseri Training and Research Hospital

Kayseri, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Erdem SAHİN, Principal İnvestigator

Role: CONTACT

Phone: +905321688683

Email: [email protected]

Yusuf MADENDAG, Central Contact Backup

Role: CONTACT

Phone: +905055011340

Email: [email protected]

Facility Contacts

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yusuf madendag

Role: primary

Other Identifiers

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2016/579

Identifier Type: -

Identifier Source: org_study_id