Gestational DiabetesNCT06676254
Role of HbA1c in Predicting Adverse Pregnancy Outcomes
An observational study of Gestational Diabetes, run by National University of Malaysia at 1 site in Malaysia.
Trial summary
This study aims to determine the reference value of HbA1c that can be used to predict adverse pregnancy outcomes. These adverse outcomes include LGA fetus, shoulder dystocia, caesarean section, pre-term birth, pre-eclampsia and fetal neonatal hypoglycaemia. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Gestational Diabetes
- How many people
- 195 participants
- Where
- 1 siteMalaysia
- Study dates
- 27 Jun 2024to 26 Jun 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Antenatal women attended antenatal clinics between January 2020-June 2024 in Hospital Canselor Tuanku Muhriz and diagnosed with GDM will be included in the study using purposive sampling method. Diagnosis of GDM is based on the Malaysia Diabetes CPG Guideline (fasting plasma glucose ≥5.1, 2 hours post-prandial ≥7.8).
Who may be able to join
- Pregnant woman with singleton pregnancy
- Confirmed diagnosis of GDM based on Malaysia CPG (≥5.1/7.8)
- HbA1c level taken at least once at any time during the pregnancy
- Delivery after 28 weeks gestation
Who cannot join
- Major fetal anomaly
- Haemoglobin level of ≤9 g/dL (moderate or severe anaemia in pregnancy)
- Women with autoimmune diseases
- Overt diabetes or pre-existing diabetes
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Malaysia1 site, 1 recruiting
- Recruiting
Department of Obstetrics & Gynaecology, Hospital Canselor Tuanku Muhriz
Cheras, Kuala Lumpur, 56000
Rahana ARahman, MD, +60391455964 ext. 5964, drrahana@ukm.edu.my
otak_13@yahoo.com
About this study
Official title: Role of HbA1c in Predicting Adverse Pregnancy Outcomes Among Gestational Diabetes Mellitus Women: a Retrospective Study
This study aims to determine the reference value of HbA1c that can be used to predict adverse pregnancy outcomes. These adverse outcomes include LGA fetus, shoulder dystocia, caesarean section, pre-term birth, pre-eclampsia and fetal neonatal hypoglycaemia.
Read the detailed description
This study involves the data in our centre concerning women with gestational diabetes mellitus. The diagnosis of gestational diabetes mellitus is based on NICE guideline whereby the fasting glucose is 5.6 mol/l or more and 2 hours post glucose load 7.8 mol/l or more. The results of HbA1c and fructosamine taken during the antenatal care are documented. Outcomes of the pregnancy are documented such as antenatal complications, mode of delivery, gestational age at delivery, intrapartum and postpartum complications and neonatal complications. The results of this study is hoped to provide information on the optimum targeted levels of HbA1c and fructosamine for patients with gestational diabetes mellitus. This is the gap in knowledge in managing this cohort of patients.
- Conditions
- Gestational Diabetes
- Keywords
- HbA1c, Gestational diabetes, large for gestational age, shoulder dystocia, caesarean section
- Medical subject headings
- Diabetes, Gestational, Shoulder Dystocia
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the HbA1c reference value in predicting adverse pregnancy outcomes
- To determine the HbA1c value to be used at each trimester in predicting adverse pregnancy outcomes
Measured: Throughout study up to 1 year
Secondary outcomes (2)
To determine the prevalence of adverse pregnancy outcomes among women with GDM
Measurement of prevalent
Measured: Throughout study up to 1 year
To assess the HbA1c value during the diagnosis of GDM and its association with adverse pregnancy outcomes
Relationship between HbA1c and adverse pregnancy outcomes
Measured: Throughout study up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2024
- Study start27 Jun 2024
- Primary completion26 Jun 2026 (estimated)
- Study completion26 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestational DiabetesStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 195 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University of Malaysia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rahana Abd Rahman, National University of Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06676254
- Sponsor's protocol ID
- JEP-2024-475
- Status last verified
- Nov 2024
- First submitted
- 12 Aug 2024
- Last updated
- 6 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of HbA1c in Predicting Adverse Pregnancy Outcomes Among Gestational Diabetes Mellitus Women: a Retrospective Study
- ClinicalTrials.gov ID
- NCT06676254
- Acronym / sponsor ID
- JEP-2024-475
- Conditions
- Gestational Diabetes
- Keywords
- HbA1c, Gestational diabetes, large for gestational age, shoulder dystocia, caesarean section
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 195 participants (estimated)
- Lead sponsor
- National University of MalaysiaUniversity, hospital or other
- Study start
- 27 Jun 2024 (actual)
- Primary completion
- 26 Jun 2026 (estimated)
- Study completion
- 26 Jun 2026 (estimated)
- First posted
- 6 Nov 2024 (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.
This study aims to determine the reference value of HbA1c that can be used to predict adverse pregnancy outcomes. These adverse outcomes include LGA fetus, shoulder dystocia, caesarean section, pre-term birth, pre-eclampsia and fetal neonatal hypoglycaemia.
Detailed description
This study involves the data in our centre concerning women with gestational diabetes mellitus. The diagnosis of gestational diabetes mellitus is based on NICE guideline whereby the fasting glucose is 5.6 mol/l or more and 2 hours post glucose load 7.8 mol/l or more. The results of HbA1c and fructosamine taken during the antenatal care are documented. Outcomes of the pregnancy are documented such as antenatal complications, mode of delivery, gestational age at delivery, intrapartum and postpartum complications and neonatal complications. The results of this study is hoped to provide information on the optimum targeted levels of HbA1c and fructosamine for patients with gestational diabetes mellitus. This is the gap in knowledge in managing this cohort of patients.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Antenatal women attended antenatal clinics between January 2020-June 2024 in Hospital Canselor Tuanku Muhriz and diagnosed with GDM will be included in the study using purposive sampling method. Diagnosis of GDM is based on the Malaysia Diabetes CPG Guideline (fasting plasma glucose ≥5.1, 2 hours post-prandial ≥7.8).
Key inclusion criteria (4 listed)
- Pregnant woman with singleton pregnancy
- Confirmed diagnosis of GDM based on Malaysia CPG (≥5.1/7.8)
- HbA1c level taken at least once at any time during the pregnancy
- Delivery after 28 weeks gestation
Key exclusion criteria (4 listed)
- Major fetal anomaly
- Haemoglobin level of ≤9 g/dL (moderate or severe anaemia in pregnancy)
- Women with autoimmune diseases
- Overt diabetes or pre-existing diabetes
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 the HbA1c reference value in predicting adverse pregnancy outcomes
Time frame: Throughout study up to 1 year
c) To determine the HbA1c value to be used at each trimester in predicting adverse pregnancy outcomes
2 secondary outcomes
To determine the prevalence of adverse pregnancy outcomes among women with GDM
Time frame: Throughout study up to 1 year
To assess the HbA1c value during the diagnosis of GDM and its association with adverse pregnancy outcomes
Time frame: Throughout study up to 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2024.
- Individual participant dataSharing planned: No
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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.
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, run by National University of Malaysia at 1 site in Malaysia.
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 4 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: looking for participants now, as of the sponsor's last update on 6 Nov 2024. 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 Malaysia. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rahana ARahman, MD (+60391455964, drrahana@ukm.edu.my), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the HbA1c reference value in predicting adverse pregnancy outcomes (time frame: Throughout study up to 1 year). 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 6 Nov 2024.