Gestational Diabetes Mellitus in PregnancyNCT05510518
Late Gestational Diabetes Mellitus Diagnosis in Obese Women
An observational study of Gestational Diabetes Mellitus in Pregnancy and Macrosomia, Fetal, run by Western Galilee Hospital-Nahariya at 1 site in Israel.
Trial summary
In the current work, we aim to perform a prospective study that will investigate the relationship between maternal obesity (BMI >30 kg/m2) and morbid obesity (BMI >35 kg/m2) with a late GDM diagnosis (>32 weeks), with an emphasis on obstetric and neonatal outcomes. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Gestational Diabetes Mellitus in Pregnancy, Macrosomia, Fetal, Dystocia, Shoulder
- What is being tested?
- oral glucose tolerance test (OGTT)
- Type of treatment
- Pill or oral medicine
- How many people
- 150 participants
- Where
- 1 siteIsrael
- Study dates
- Aug 2022to Feb 2025
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Women hospitalized in the Mother and Fetus Unit for various reasons, e.g., premature labor, amniotic fluid leakage, reduced fetal movements, following a car accident, etc.
Who may be able to join
- Women with normal OGTT at weeks 24-28
- Women with BMI >30 kg/m2
Who cannot join
- Multiple pregnancy
- Fetal defects
- Women who received steroids within the preceding week
Trial locations and contacts
1 site in 1 country.
About this study
In the current work, we aim to perform a prospective study that will investigate the relationship between maternal obesity (BMI >30 kg/m2) and morbid obesity (BMI >35 kg/m2) with a late GDM diagnosis (>32 weeks), with an emphasis on obstetric and neonatal outcomes.
Read the detailed description
Methods
Study design:
A prospective study that will evaluate the rate of diagnosis of late GDM and clinical effect of performing a repeat OGTT beyond week 32 in women with obesity (BMI >30 kg/m2) and morbid obesity (BMI >35 kg/m2) for whom loading sugar was normal in the second trimester. The study will be carried out in the Mother and Fetus Unit at the Galilee Medical Center in Nahariya, Israel.
Study population:
Target population: women hospitalized in the Mother and Fetus Unit for various reasons, e.g., premature labor, amniotic fluid leakage, reduced fetal movements, following a car accident, etc.
Inclusion criteria:
- Women with normal OGTT at weeks 24-28
- Women with BMI >30 kg/m2
Exclusion criteria:
- Twins
- Fetal abnormalities
- Women who received steroids within the preceding week We will invite women who meet the enrollment criteria to participate in the study, and perform an OGTT.
Research objectives:
- Primary endpoints: The percentage of obese women with late GDM diagnosis will be divided into two groups according to BMI:
- BMI 30-35 kg/m2
- BMI >35 kg/m2
- Secondary endpoints:
- Differences in the following obstetric outcomes between women diagnosed or not diagnosed with GDM: percentage of macrosomia, delivery method, shoulder dystocia, grade 3-4 tear
- Differences in the following newborn outcomes between women diagnosed or not diagnosed with GDM: hypoglycemia, jaundice, need for phototherapy, polycythemia, hospitalization in neonatal intensive care, Apgar score, and newborn pH
Research procedure, interpretation of results, and patient follow-up:
- The OGTT involves assessing fasting blood glucose, drinking a solution comprising 100 g of glucose, and three glucose tests at one, two, and three hours following glucose load.
- Interpretation of the OGTT result is performed according to Carpenter-Coustan criteria [6]
- Women who are not diagnosed with GDM will be discharged for continued follow-up for regular prenatal care and the reason for her hospitalization.
- Per standard of care (regardless of research involvement) women diagnosed with GDM will receive counseling by a dietitian and other key department staff and undergo a complete glucose curve (seven tests per day: fasting, before each of three meals, and two hours after each meal).
- If more than 30% of glucose tests are abnormal, the patient will receive standard drug treatment.
- Follow-up is usually performed for 1-2 days in the hospital ward, after which women are discharged to ambulatory follow-up at the Mother and Fetus Clinic of the medical center.
Statistical analysis:
The sample size was calculated using the chi square formula for comparing two groups.
In a previous study in which repeat OGTT was performed beyond week 32 after initially normal results at week 24-28, the diagnosis rate of GDM for the total sample was 10%. An effect size of 20% was considered significant between obese and morbidly obese women with alpha=0.05, power 80%. The calculated sample size was 124 (at least 62 obese and 62 morbidly obese women).
- Conditions
- Gestational Diabetes Mellitus in Pregnancy, Macrosomia, Fetal, Dystocia, Shoulder, Neonatal Jaundice, Polycythemia, Hypoglycemia Neonatal
- Being tested
- oral glucose tolerance test (OGTT)
- Keywords
- gestational diabetes mellitus, fetal macrosomia, shoulder dystocia, maternal obesity, maternal morbid obesity
- Medical subject headings
- Fetal Macrosomia, Shoulder Dystocia, Jaundice, Neonatal, Polycythemia, Obesity, Obesity, Morbid, Diabetes, Gestational, Pregnancy in Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oral glucose tolerance test (OGTT)Diagnostic test
- The OGTT involves assessing fasting blood glucose, drinking a solution comprising 100 g of glucose, and three glucose tests at one, two, and three hours following glucose load.
| Study group | Role | What they receive |
|---|---|---|
| BMI >30 kg/m2 | Singleton pregnant women with normal OGTT at 24-28 weeks of gestation and BMI >30 kg/m2 Receives: Diagnostic Test: oral glucose tolerance test (OGTT) | |
| BMI >35 kg/m2 | Singleton pregnant women with normal OGTT at 24-28 weeks of gestation and BMI >35 kg/m2 Receives: Diagnostic Test: oral glucose tolerance test (OGTT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of obese women that will be diagnosed with late GDM diagnosis by the OGTT
The percentage of obese women with late GDM diagnosis will be analyzed per BMI group:
- BMI 30-35 kg/m2
- BMI >35 kg/m2
Measured: through study completion, an average of 1 year
Secondary outcomes (3)
neonatal macrosomia rate
Measured: From admission to discharge, up to 1 week
neonatal hypoglycemia rate
Measured: From neonatal admission to discharge, up to 1 week
neonatal hospitalization in intensive care rate
Measured: From neonatal admission to discharge, up to 4 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2022
- Study startAug 2022 (estimated)
- Primary completionDec 2024 (estimated)
- Study completionFeb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Gestational Diabetes Mellitus in PregnancyStudies 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 only
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Western Galilee Hospital-Nahariya
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dr. Maya Wolf, Western Galilee Hospital-Nahariya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05510518
- Sponsor's protocol ID
- 0115-22-NHR
- Status last verified
- Aug 2022
- First submitted
- 28 Jul 2022
- Last updated
- 22 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Hales CM, Carroll MD, Fryar CD, Ogden CL. Prevalence of Obesity and Severe Obesity Among Adults: United States, 2017-2018. NCHS Data Brief. 2020 Feb;(360):1-8.
PubMed 32487284Arabin B, Stupin JH. Overweight and Obesity before, during and after Pregnancy: Part 2: Evidence-based Risk Factors and Interventions. Geburtshilfe Frauenheilkd. 2014 Jul;74(7):646-655. doi: 10.1055/s-0034-1368462.
PubMed 25100879Abu Shqara R, Or S, Wiener Y, Lowenstein L, Frank Wolf M. Clinical implications of the 100-g oral glucose tolerance test in the third trimester. Arch Gynecol Obstet. 2023 Feb;307(2):421-429. doi: 10.1007/s00404-022-06520-5. Epub 2022 Mar 28.
PubMed 35344083Zilberberg E, Mazaki S, Zilberman N, Mazkereth R, Weisz B, Sivan E, et al. Should late third trimester oral glucose tolerance test be offered for patients with suspected macrosomia or polyhydramnios? Evidence in support of the clinical importance of this policy. Am J Obstet Gynecol. 2012;206(1):S122.
Kandauda C, Wanasinghe W. Repeat OGTT at 34 - 36 weeks to detect the late occurrence of GDM: A descriptive cross-sectional study conducted at the professorial unit, teaching hospital Peradeniya, Sri Lanka. Adv Reproduct Sci. 2020;8:157-65.
Carpenter MW, Coustan DR. Criteria for screening tests for gestational diabetes. Am J Obstet Gynecol. 1982 Dec 1;144(7):768-73. doi: 10.1016/0002-9378(82)90349-0.
PubMed 7148898Harrison RK, Cruz M, Wong A, Davitt C, Palatnik A. The timing of initiation of pharmacotherapy for women with gestational diabetes mellitus. BMC Pregnancy Childbirth. 2020 Dec 11;20(1):773. doi: 10.1186/s12884-020-03449-y.
PubMed 33308193
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Late Gestational Diabetes Mellitus Diagnosis in Obese Women
- ClinicalTrials.gov ID
- NCT05510518
- Acronym / sponsor ID
- 0115-22-NHR
- Conditions
- Gestational Diabetes Mellitus in Pregnancy, Macrosomia, Fetal, Dystocia, Shoulder, Neonatal Jaundice, Polycythemia, Hypoglycemia Neonatal
- Keywords
- gestational diabetes mellitus, fetal macrosomia, shoulder dystocia, maternal obesity, maternal morbid obesity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Western Galilee Hospital-NahariyaOther government
- Study start
- Aug 2022 (estimated)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Feb 2025 (estimated)
- First posted
- 22 Aug 2022 (actual)
- 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.
In the current work, we aim to perform a prospective study that will investigate the relationship between maternal obesity (BMI >30 kg/m2) and morbid obesity (BMI >35 kg/m2) with a late GDM diagnosis (>32 weeks), with an emphasis on obstetric and neonatal outcomes.
Detailed description
Methods
Study design:
A prospective study that will evaluate the rate of diagnosis of late GDM and clinical effect of performing a repeat OGTT beyond week 32 in women with obesity (BMI >30 kg/m2) and morbid obesity (BMI >35 kg/m2) for whom loading sugar was normal in the second trimester. The study will be carried out in the Mother and Fetus Unit at the Galilee Medical Center in Nahariya, Israel.
Study population:
Target population: women hospitalized in the Mother and Fetus Unit for various reasons, e.g., premature labor, amniotic fluid leakage, reduced fetal movements, following a car accident, etc.
Inclusion criteria:
- Women with normal OGTT at weeks 24-28
- Women with BMI >30 kg/m2
Exclusion criteria:
- Twins
- Fetal abnormalities
- Women who received steroids within the preceding week We will invite women who meet the enrollment criteria to participate in the study, and perform an OGTT.
Research objectives:
- Primary endpoints: The percentage of obese women with late GDM diagnosis will be divided into two groups according to BMI:
- BMI 30-35 kg/m2
- BMI >35 kg/m2
- Secondary endpoints:
- Differences in the following obstetric outcomes between women diagnosed or not diagnosed with GDM: percentage of macrosomia, delivery method, shoulder dystocia, grade 3-4 tear
- Differences in the following newborn outcomes between women diagnosed or not diagnosed with GDM: hypoglycemia, jaundice, need for phototherapy, polycythemia, hospitalization in neonatal intensive care, Apgar score, and newborn pH
Research procedure, interpretation of results, and patient follow-up:
- The OGTT involves assessing fasting blood glucose, drinking a solution comprising 100 g of glucose, and three glucose tests at one, two, and three hours following glucose load.
- Interpretation of the OGTT result is performed according to Carpenter-Coustan criteria [6]
- Women who are not diagnosed with GDM will be discharged for continued follow-up for regular prenatal care and the reason for her hospitalization.
- Per standard of care (regardless of research involvement) women diagnosed with GDM will receive counseling by a dietitian and other key department staff and undergo a complete glucose curve (seven tests per day: fasting, before each of three meals, and two hours after each meal).
- If more than 30% of glucose tests are abnormal, the patient will receive standard drug treatment.
- Follow-up is usually performed for 1-2 days in the hospital ward, after which women are discharged to ambulatory follow-up at the Mother and Fetus Clinic of the medical center.
Statistical analysis:
The sample size was calculated using the chi square formula for comparing two groups.
In a previous study in which repeat OGTT was performed beyond week 32 after initially normal results at week 24-28, the diagnosis rate of GDM for the total sample was 10%. An effect size of 20% was considered significant between obese and morbidly obese women with alpha=0.05, power 80%. The calculated sample size was 124 (at least 62 obese and 62 morbidly obese women).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BMI >30 kg/m2 | – | Diagnostic Test: oral glucose tolerance test (OGTT)Singleton pregnant women with normal OGTT at 24-28 weeks of gestation and BMI >30 kg/m2 |
| BMI >35 kg/m2 | – | Diagnostic Test: oral glucose tolerance test (OGTT)Singleton pregnant women with normal OGTT at 24-28 weeks of gestation and BMI >35 kg/m2 |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Women hospitalized in the Mother and Fetus Unit for various reasons, e.g., premature labor, amniotic fluid leakage, reduced fetal movements, following a car accident, etc.
Key inclusion criteria (2 listed)
- Women with normal OGTT at weeks 24-28
- Women with BMI >30 kg/m2
Key exclusion criteria (3 listed)
- Multiple pregnancy
- Fetal defects
- Women who received steroids within the preceding week
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| oral glucose tolerance test (OGTT)• The OGTT involves assessing fasting blood glucose, drinking a solution comprising 100 g of glucose, and three glucose tests at one, two, and three hours following glucose load. | Diagnostic test | BMI >30 kg/m2, BMI >35 kg/m2 |
Primary outcome
Number of obese women that will be diagnosed with late GDM diagnosis by the OGTT
Time frame: through study completion, an average of 1 year
The percentage of obese women with late GDM diagnosis will be analyzed per BMI group: * BMI 30-35 kg/m2 * BMI >35 kg/m2
3 secondary outcomes
neonatal macrosomia rate
Time frame: From admission to discharge, up to 1 week
neonatal hypoglycemia rate
Time frame: From neonatal admission to discharge, up to 1 week
neonatal hospitalization in intensive care rate
Time frame: From neonatal admission to discharge, up to 4 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2022.
- Background: PubMed 32487284Hales CM, Carroll MD, Fryar CD, Ogden CL. Prevalence of Obesity and Severe Obesity Among Adults: United States, 2017-2018. NCHS Data Brief. 2020 Feb;(360):1-8.
- Background: PubMed 25100879Arabin B, Stupin JH. Overweight and Obesity before, during and after Pregnancy: Part 2: Evidence-based Risk Factors and Interventions. Geburtshilfe Frauenheilkd. 2014 Jul;74(7):646-655. doi: 10.1055/s-0034-1368462.
- Background: PubMed 35344083Abu Shqara R, Or S, Wiener Y, Lowenstein L, Frank Wolf M. Clinical implications of the 100-g oral glucose tolerance test in the third trimester. Arch Gynecol Obstet. 2023 Feb;307(2):421-429. doi: 10.1007/s00404-022-06520-5. Epub 2022 Mar 28.
- BackgroundZilberberg E, Mazaki S, Zilberman N, Mazkereth R, Weisz B, Sivan E, et al. Should late third trimester oral glucose tolerance test be offered for patients with suspected macrosomia or polyhydramnios? Evidence in support of the clinical importance of this policy. Am J Obstet Gynecol. 2012;206(1):S122.
- BackgroundKandauda C, Wanasinghe W. Repeat OGTT at 34 - 36 weeks to detect the late occurrence of GDM: A descriptive cross-sectional study conducted at the professorial unit, teaching hospital Peradeniya, Sri Lanka. Adv Reproduct Sci. 2020;8:157-65.
- Background: PubMed 7148898Carpenter MW, Coustan DR. Criteria for screening tests for gestational diabetes. Am J Obstet Gynecol. 1982 Dec 1;144(7):768-73. doi: 10.1016/0002-9378(82)90349-0.
- Background: PubMed 33308193Harrison RK, Cruz M, Wong A, Davitt C, Palatnik A. The timing of initiation of pharmacotherapy for women with gestational diabetes mellitus. BMC Pregnancy Childbirth. 2020 Dec 11;20(1):773. doi: 10.1186/s12884-020-03449-y.
- Individual participant dataSharing planned: Undecided
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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.
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 Gestational Diabetes Mellitus in Pregnancy and Macrosomia, Fetal, run by Western Galilee Hospital-Nahariya at 1 site in Israel.
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 2 inclusion and 3 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 22 Aug 2022. 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 Israel. 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 Maya Wolf, MD (+972-2-9107186, MayaW@gmc.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of obese women that will be diagnosed with late GDM diagnosis by the OGTT (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05510518, which also lists 7 linked publications.
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 22 Aug 2022.