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Hyperemesis; Gravidarum, With DehydrationNCT02989337

Endothelial Dysfunction in Hyperemesis Gravidarum

An observational study of Hyperemesis; Gravidarum, With Dehydration, run by Kayseri Education and Research Hospital at 1 site in Turkey (Türkiye).

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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

Who is it for?
Ages 18 to 35 years, women onlyHealthy volunteers can take part
How many people
50 participants
Where
1 siteTurkey (Türkiye)
Study dates
Dec 2016to Mar 2017
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 35 years
  • Women only
  • Healthy volunteers accepted
  • Adult

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.

Who may be able to join

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

Who cannot join

  • Other pathologies causing nausea and vomiting;
  • gastroenteritis
  • gastroparesis
  • gall duct diseases
  • hepatitis
  • peptic ulcers
Show all 26Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Erdem SAHİN, Principal İnvestigator contact

+905321688683

erdemsahin07@hotmail.com

Yusuf MADENDAG, Central Contact Backup contact

+905055011340

yusufmadendag@gmail.com

Turkey (Türkiye)1 site, 1 recruiting
  • Kayseri Training and Research Hospital

    Kayseri, 38000

    yusuf madendag, +905055011340, yusufmadedag@gmail.com

    Recruiting

Other trials in Turkey (Türkiye)

About this study

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

Read the 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.

Keywords
Hyperemesis Gravidarum, Inflammatory adhesion molecules, Dehydration
Medical subject headings
Hyperemesis Gravidarum, Dehydration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02989337
Study groupRoleWhat they receive
hyperemesis gravidarum with dehydrationThe first group was formed of the patients diagnosed hyperemesis gravidarum with dehydration
Control groupThe 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 being measured

The primary outcome is the main question the study is designed to answer.

  1. Serum inflammatory adhesion molecules in hyperemesis gravidarum

    Measured: 4 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Dec 2016 (estimated)
  2. Study startDec 2016
  3. Primary completionMar 2017 (estimated)
  4. Study completionMar 2017 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Cross-sectional
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02989337
Sponsor's protocol ID
2016/579
Status last verified
Dec 2016
First submitted
8 Dec 2016
Last updated
12 Dec 2016
Results posted
No

Questions about this trial

What is this clinical trial studying?

An observational study of Hyperemesis; Gravidarum, With Dehydration, run by Kayseri Education and Research Hospital at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 12 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Erdem SAHİN, Principal İnvestigator (+905321688683, erdemsahin07@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Serum inflammatory adhesion molecules in hyperemesis gravidarum (time frame: 4 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2016.

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