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).
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
- Conditions the study is for
- Hyperemesis; Gravidarum, With Dehydration
- 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.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Kayseri Training and Research Hospital
Kayseri, 38000
yusuf madendag, +905055011340, yusufmadedag@gmail.com
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 group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
- First posted12 Dec 2016 (estimated)
- Study startDec 2016
- Primary completionMar 2017 (estimated)
- Study completionMar 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hyperemesis; Gravidarum, With DehydrationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Kayseri Education and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Erdem Sahin, Kayseri Education and Research Hospital
- Investigators
- Erdem SAHİN, Principal investigator, Kayseri Training and Research Hospital
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
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endothelial Dysfunction in Hyperemesis Gravidarum
- ClinicalTrials.gov ID
- NCT02989337
- Acronym / sponsor ID
- 2016/579
- Keywords
- Hyperemesis Gravidarum, Inflammatory adhesion molecules, Dehydration
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Kayseri Education and Research HospitalOther government
- Study start
- Dec 2016
- Primary completion
- Mar 2017 (estimated)
- Study completion
- Mar 2017 (estimated)
- First posted
- 12 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- 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.
Key inclusion criteria (4 listed)
- 6-13 gestational weeks
- between 18-35 years of age
- Single pregnancy
- Dehydration due to HG
Key exclusion criteria (26 listed)
- Other pathologies causing nausea and vomiting;
- gastroenteritis
- gastroparesis
- gall duct diseases
- hepatitis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Serum inflammatory adhesion molecules in hyperemesis gravidarum
Time frame: 4 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2016.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erdem SAHİN principal investigator
Kayseri Training and Research Hospital
1 site in 1 country: see every site and its status.
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.