Hyperemesis; Gravidarum, With DehydrationNCT02963753
Hyperemesis Gravidarum and 75 Gram Oral Glucose Tolerance Test
An observational study of Hyperemesis; Gravidarum, With Dehydration and Gestational Diabetes, run by Kayseri Education and Research Hospital.
Trial summary
Hyperemesis gravidarum (HEG) is not only nausea and vomiting of pregnancy, but it is also a clinical syndrome including endocrine and metabolic complications. Recently, some investigators have been begun performing researches related to the development of gestational diabetes mellitus (GDM) in pregnant women with HEG… 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, Gestational Diabetes
- How many people
- 560 participants
- Where
- No sites listed yet
- Study dates
- Jan 2016to Nov 2016
- 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: This study was carried out with two groups. The study group consisted of women hospitalized for HEG during first trimester of their pregnancy, whereas the control group included all other women who delivered in the same period. When the pregnant women had those symptoms such as the presence of intractable vomiting during pregnancy associated with dehydration, electrolyte,and/or metabolic disturbances, as well as a weight loss 5% or more, they were diagnosed as HEG.
Who may be able to join
- between 18 and 35 years-old singleton pregnancies and performed 75 gram OGTT
Who cannot join
- Other causes lead to nausea and vomiting in pregnancy such as gastroenteritis, gastroparesis, hepatitis, intestinal obstruction, peptic ulcer, appendicitis, pyelonephritis, urolithiasis, ovarian torsion, diabetes mellitus, hyperthyroidism, hyperparathyroidism, migraine.
- And also patients who have risks for GDM such as body mass index > 30, history of GDM in previous pregnancy and diabetes in the family were excluded.
About this study
Official title: Effect of Hyperemesis Gravidarum on 75 Gram Oral Glucose Tolerance Test Screening and Gestational Diabetes Mellitus
Hyperemesis gravidarum (HEG) is not only nausea and vomiting of pregnancy, but it is also a clinical syndrome including endocrine and metabolic complications. Recently, some investigators have been begun performing researches related to the development of gestational diabetes mellitus (GDM) in pregnant women with HEG because they think about those metabolic and endocrine complications of HEG.In the literature there are few studies assessing how HEG has effects on GDM or 75 gram oral glucose tolerance test (OGTT). So the investigators aim to evaluate the effects of HEG on 75 gram OGTT.
Read the detailed description
This retrospective controlled study conducted by Obstetrics and Gynecology clinics of Kayseri Training and Research Hospital.Pregnant women who delivered at the Kayseri Education and Training Hospital of Medicine, in Turkey, between January 2010 and September 2016 were identified.This study was carried out with two groups. The study group consisted of women hospitalized for Hyperemesis gravidarum (HEG) during first trimester of their pregnancy, whereas the control group included all other women who delivered in the same period.Screening for GDM was performed twice during pregnancy. The first screening was performed during the first trimester using the random plasma glucose test with a cutoff value of 109 mg/dl. Screening for GDM was performed for all women during their first prenatal visit, regardless of the presence or absence of hyperemesis-associated symptoms.The second screening was performed during the second trimester, between 24 and 27 weeks, using a 75-g oral glucose tolerance test (OGTT), after pregnant women with HEG got rid of hyperemesis. GDM was diagnosed on the basis of the universal criteria established by the International Association of Diabetes and Pregnancy Study Group: a plasma glucose level that met or exceeded the fasting cutoff value 92 mg/dl, the first-hour cutoff value 180 mg/dl, or the second-hour cutoff value 153mg/dl.
To be considered for diagnosis of pre-gestational diabetes mellitus, women had to meet at least one of the following criteria: the fasting plasma glucose test with a cutoff value of 126 mg/dl or the random plasma glucose test with a cutoff value of 200 mg/dl or the second-hour cutoff value 153mg/dl after 75 gram OGGT (American Diabetes Association) The delivery midwifery and medical records were retrospectively evaluated. All of the patient's body mass index (BMI,calculated as weight in kilograms divided by the square of height in meters), urine ketone levels and ages were recorded separately both in the initial exam and during performing 75 gram OGTT.
- Keywords
- Hyperemesis gravidarum, gestational diabetes mellitus, oral glucose tolerance test
- Medical subject headings
- Hyperemesis Gravidarum, Diabetes, Gestational
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 group | The study group consisted of women hospitalized for hyperemesis during first trimester of their pregnancy | |
| the control group | whereas the control group included all other women who delivered in the same period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine serum glucose levels in both groups during 75 gram oral glucose tolerance test screening
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2016 (estimated)
- Study startJan 2016
- Primary completionNov 2016
- Study completionNov 2016
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
- Retrospective
- Enrolment
- 560 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kayseri Education and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Yusuf MADENDAG, Kayseri Education and Research Hospital
- Investigators
- YUSUF MADENDAG, Principal investigator, Kayseri Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02963753
- Sponsor's protocol ID
- 2017/173
- Status last verified
- Apr 2017
- First submitted
- 10 Nov 2016
- Last updated
- 13 Apr 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Hyperemesis Gravidarum on 75 Gram Oral Glucose Tolerance Test Screening and Gestational Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT02963753
- Acronym / sponsor ID
- 2017/173
- Keywords
- Hyperemesis gravidarum, gestational diabetes mellitus, oral glucose tolerance test
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 560 participants (actual)
- Lead sponsor
- Kayseri Education and Research HospitalOther government
- Study start
- Jan 2016
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 15 Nov 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.
Hyperemesis gravidarum (HEG) is not only nausea and vomiting of pregnancy, but it is also a clinical syndrome including endocrine and metabolic complications. Recently, some investigators have been begun performing researches related to the development of gestational diabetes mellitus (GDM) in pregnant women with HEG because they think about those metabolic and endocrine complications of HEG.In the literature there are few studies assessing how HEG has effects on GDM or 75 gram oral glucose tolerance test (OGTT). So the investigators aim to evaluate the effects of HEG on 75 gram OGTT.
Detailed description
This retrospective controlled study conducted by Obstetrics and Gynecology clinics of Kayseri Training and Research Hospital.Pregnant women who delivered at the Kayseri Education and Training Hospital of Medicine, in Turkey, between January 2010 and September 2016 were identified.This study was carried out with two groups. The study group consisted of women hospitalized for Hyperemesis gravidarum (HEG) during first trimester of their pregnancy, whereas the control group included all other women who delivered in the same period.Screening for GDM was performed twice during pregnancy. The first screening was performed during the first trimester using the random plasma glucose test with a cutoff value of 109 mg/dl. Screening for GDM was performed for all women during their first prenatal visit, regardless of the presence or absence of hyperemesis-associated symptoms.The second screening was performed during the second trimester, between 24 and 27 weeks, using a 75-g oral glucose tolerance test (OGTT), after pregnant women with HEG got rid of hyperemesis. GDM was diagnosed on the basis of the universal criteria established by the International Association of Diabetes and Pregnancy Study Group: a plasma glucose level that met or exceeded the fasting cutoff value 92 mg/dl, the first-hour cutoff value 180 mg/dl, or the second-hour cutoff value 153mg/dl.
To be considered for diagnosis of pre-gestational diabetes mellitus, women had to meet at least one of the following criteria: the fasting plasma glucose test with a cutoff value of 126 mg/dl or the random plasma glucose test with a cutoff value of 200 mg/dl or the second-hour cutoff value 153mg/dl after 75 gram OGGT (American Diabetes Association) The delivery midwifery and medical records were retrospectively evaluated. All of the patient's body mass index (BMI,calculated as weight in kilograms divided by the square of height in meters), urine ketone levels and ages were recorded separately both in the initial exam and during performing 75 gram OGTT.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| hyperemesis gravidarum group | – | –The study group consisted of women hospitalized for hyperemesis during first trimester of their pregnancy |
| the control group | – | –whereas the control group included all other women who delivered in the same period. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- This study was carried out with two groups. The study group consisted of women hospitalized for HEG during first trimester of their pregnancy, whereas the control group included all other women who delivered in the same period. When the pregnant women had those symptoms such as the presence of intractable vomiting during pregnancy associated with dehydration, electrolyte,and/or metabolic disturbances, as well as a weight loss 5% or more, they were diagnosed as HEG.
Key inclusion criteria (1 listed)
- between 18 and 35 years-old singleton pregnancies and performed 75 gram OGTT
Key exclusion criteria (2 listed)
- Other causes lead to nausea and vomiting in pregnancy such as gastroenteritis, gastroparesis, hepatitis, intestinal obstruction, peptic ulcer, appendicitis, pyelonephritis, urolithiasis, ovarian torsion, diabetes mellitus, hyperthyroidism, hyperparathyroidism, migraine.
- And also patients who have risks for GDM such as body mass index > 30, history of GDM in previous pregnancy and diabetes in the family were excluded.
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
To determine serum glucose levels in both groups during 75 gram oral glucose tolerance test screening
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2017.
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.
YUSUF MADENDAG principal investigator
Kayseri Education and Research Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Hyperemesis; Gravidarum, With Dehydration and Gestational Diabetes, run by Kayseri Education and Research Hospital.
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 1 inclusion and 2 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: finished, as of the sponsor's last update on 13 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine serum glucose levels in both groups during 75 gram oral glucose tolerance test screening (time frame: 3 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 13 Apr 2017.