Gestational Diabetes Mellitus in PregnancyNCT06021691
Gestational Diabetes Mother-infant Cohort
An observational study of Gestational Diabetes Mellitus in Pregnancy and Cognitive Impairment, run by Gansu Provincial Maternal and Child Health Care Hospital at 1 site in China.
Trial summary
The bi-directional dynamic cohort study is to learn about the effects of prenatal exposure to high blood glucose levels and postnatal nurturing environment factors on delayed language development in children. Read more about this study
- Who is it for?
- Ages 1 year to 3 yearsHealthy volunteers can take part
- Conditions the study is for
- Gestational Diabetes Mellitus in Pregnancy, Cognitive Impairment, Cohort Study
- What is being tested?
- Acquired nurturing environment
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 600 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2023to 30 Nov 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 1 year to 3 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: The pregnant women with abnormal blood glucose levels and the offspring
Who may be able to join
- Children 1.5-2.5 years old with no serious underlying diseases and no hearing impairment.
Who cannot join
- diagnosed hearing impairment, organic dysarthria, oral disease; (ii) cerebral palsy;
- neurological and hereditary metabolic diseases; (iv) deaf father/mother.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
GansuPMCH
Lanzhou, Gansu, 730050
Yanxia Wang, Dr., 13893210796, 1091771450@qq.com
About this study
Official title: A Cohort Study on the Impact of Gestational Blood Glucose Management and Postnatal Nurturing Environment on Delayed Language Development in Children
The bi-directional dynamic cohort study is to learn about the effects of prenatal exposure to high blood glucose levels and postnatal nurturing environment factors on delayed language development in children. The study investigated the results of blood glucose screening during pregnancy for the children's mothers, and followed up on the blood glucose management effectiveness of pregnant women with abnormal blood glucose levels before delivery. Participants will be also surveyed the "S-S method for language development assessment, "gsell Scale", and "0-6 year-old family nurturing environment evaluation scale" to evaluate the language development and family nurturing environment.
Read the detailed description
Glucose management during pregnancy and the postnatal nurturing environment are keys to early detection and early intervention of language delay, which is important to reduce abnormal language development in children. In this study, mothers diagnosed with gestational diabetes mellitus in the department of hospital and offspring were used as participants. The investigators take a follow-up visit to participants' offspring using the S-S method of language development assessment, gsell Infant and Toddler Development Scale, and 0-6 years old family parenting environment evaluation scale. The bi-directional dynamic cohort study is to learn about the effects of prenatal exposure to high blood glucose levels and postnatal nurturing environment factors on delayed language development in children.
- Being tested
- Acquired nurturing environment
- Keywords
- Child cognitive impairment, Intrauterine high-glucose environment, Acquired nurture environment
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acquired nurturing environmentBehavioural
Superimposed effects of intrauterine high-sugar environment exposure and postnatal nurturing environment exposure
| Study group | Role | What they receive |
|---|---|---|
| Gestational diabetes offspring cohort | The Gestational diabetes(GDM) offspring cohort is to learn about language development assessment in 2-year-old children and causal association with their mother who diagnosed GDM Receives: Behavioral: Acquired nurturing environment | |
| Healthy maternal offspring cohort | Healthy maternal offspring cohort is to learn about language development assessment in 2-year-old children and causal association with their health mother Receives: Behavioral: Acquired nurturing environment |
What is being measured
The primary outcome is the main question the study is designed to answer.
delayed language development in children
"Number of participants diagnosed with GDM," "Number of offspring of participants who participated in the survey of family nurturing environments," and "Composition ratio of offspring with GDM who presented with language delays."
Measured: 2023.1-2025.11
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2023
- Study start1 Feb 2023
- Primary completion30 Nov 2025 (estimated)
- Study completion30 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gansu Provincial Maternal and Child Health Care Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cheng Wang, Principal investigator, Gansu Provincial Maternal and Child Health Care Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06021691
- Sponsor's protocol ID
- NCRCCHD-2022-GP-17
- Status last verified
- Aug 2023
- First submitted
- 7 Jun 2023
- Last updated
- 1 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cohort Study on the Impact of Gestational Blood Glucose Management and Postnatal Nurturing Environment on Delayed Language Development in Children
- ClinicalTrials.gov ID
- NCT06021691
- Acronym / sponsor ID
- NCRCCHD-2022-GP-17
- Keywords
- Child cognitive impairment, Intrauterine high-glucose environment, Acquired nurture environment
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Gansu Provincial Maternal and Child Health Care HospitalUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 30 Nov 2025 (estimated)
- Study completion
- 30 Nov 2025 (estimated)
- First posted
- 1 Sep 2023 (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.
The bi-directional dynamic cohort study is to learn about the effects of prenatal exposure to high blood glucose levels and postnatal nurturing environment factors on delayed language development in children. The study investigated the results of blood glucose screening during pregnancy for the children's mothers, and followed up on the blood glucose management effectiveness of pregnant women with abnormal blood glucose levels before delivery. Participants will be also surveyed the "S-S method for language development assessment, "gsell Scale", and "0-6 year-old family nurturing environment evaluation scale" to evaluate the language development and family nurturing environment.
Detailed description
Glucose management during pregnancy and the postnatal nurturing environment are keys to early detection and early intervention of language delay, which is important to reduce abnormal language development in children. In this study, mothers diagnosed with gestational diabetes mellitus in the department of hospital and offspring were used as participants. The investigators take a follow-up visit to participants' offspring using the S-S method of language development assessment, gsell Infant and Toddler Development Scale, and 0-6 years old family parenting environment evaluation scale. The bi-directional dynamic cohort study is to learn about the effects of prenatal exposure to high blood glucose levels and postnatal nurturing environment factors on delayed language development in children.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gestational diabetes offspring cohort | – | Behavioral: Acquired nurturing environmentThe Gestational diabetes(GDM) offspring cohort is to learn about language development assessment in 2-year-old children and causal association with their mother who diagnosed GDM |
| Healthy maternal offspring cohort | – | Behavioral: Acquired nurturing environmentHealthy maternal offspring cohort is to learn about language development assessment in 2-year-old children and causal association with their health mother |
Who may qualify
- Ages
- 1 year to 3 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- The pregnant women with abnormal blood glucose levels and the offspring
Key inclusion criteria (1 listed)
- Children 1.5-2.5 years old with no serious underlying diseases and no hearing impairment.
Key exclusion criteria (2 listed)
- diagnosed hearing impairment, organic dysarthria, oral disease; (ii) cerebral palsy;
- neurological and hereditary metabolic diseases; (iv) deaf father/mother.
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 |
|---|---|---|
| Acquired nurturing environmentSuperimposed effects of intrauterine high-sugar environment exposure and postnatal nurturing environment exposure | Behavioural | Gestational diabetes offspring cohort, Healthy maternal offspring cohort |
Primary outcome
delayed language development in children
Time frame: 2023.1-2025.11
"Number of participants diagnosed with GDM," "Number of offspring of participants who participated in the survey of family nurturing environments," and "Composition ratio of offspring with GDM who presented with language delays."
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2023.
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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.
Cheng Wang principal investigator
Gansu Provincial Maternal and Child Health Care 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 Gestational Diabetes Mellitus in Pregnancy and Cognitive Impairment, run by Gansu Provincial Maternal and Child Health Care Hospital at 1 site in China.
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: status not confirmed, as of the sponsor's last update on 1 Sep 2023. 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 China. 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 Yanxia Wang, Dr. (86-0931-5188689, 1091771450@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
delayed language development in children (time frame: 2023.1-2025.11). 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 1 Sep 2023.