Gestational DiabetesNCT04421053
Weight Gain Recommendations for Chinese Women With Gestational Diabetes Mellitus
An observational study of Gestational Diabetes and Gestational Weight Gain, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
The 2009 IOM recommendation value for weight gain during pregnancy is widely used. Due to the unclear relationship between gestational diabetes mellitus and weight gain during pregnancy when formulating this recommendation value, pregnant women with gestational diabetes mellitus were excluded from the study… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Gestational Diabetes, Gestational Weight Gain
- What is being tested?
- prenatal care for women with GDM
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 4,050 participants
- Where
- 1 siteChina
- Study dates
- 24 Mar 2020to 30 Jun 2022
- 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 45 years
- Women only
- No healthy volunteers
- Adult
Study population: pregnancies with gestational diabetes mellitus
Who may be able to join
- Pregnant women who have regular labor inspection and delivery in the labor inspection hospital;
- Pregnant women with gestational diabetes diagnosed by OGTT at 24 to 28 weeks of pregnancy;
- Singleton pregnancy;
- Those who can skillfully use mobile phones and other electronic devices for scientific follow-up and voluntarily record their daily weight;
- Voluntary signing of informed consent.
Who cannot join
- Patients with pre-pregnancy diabetes mellitus or abnormal OGTT screening in early pregnancy;
- diabetic ketoacidosis,high blood sugar of high permeability anemia,leukemia, and lymphoma without clinical control.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of ob gyn, Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
Liangkun Ma, MD, +8613021961166, MaLiangKun@pumch.cn
Ying Tian, 15110790115, 1220325578@qq.com
About this study
Official title: Gestational Weight Gain (GWG) Recommendations for Chinese Women With Gestational Diabetes Mellitus (GDM)
The 2009 IOM recommendation value for weight gain during pregnancy is widely used. Due to the unclear relationship between gestational diabetes mellitus and weight gain during pregnancy when formulating this recommendation value, pregnant women with gestational diabetes mellitus were excluded from the study population. Control of appropriate weight gain and control of blood glucose stability is an important part of GDM management in pregnant women. The incidence of GDM in China is about 15%-20%, and the number of pregnant women with GDM ranks first in the world. For the sake of the current and long-term health of maternal and infant, it is of great significance to explore the appropriate weight gain range and formulate the recommended value for GDM pregnant women as an independent population. This project intends to use prospective cohort study of combining the observation of pregnant women with gestational diabetes blood sugar and weight changes, through the comparison of normal pregnant women suitable scope of weight gain, analyzes its influence on adverse pregnancy outcomes, increased the weight of gestational diabetes women recommended value is put forward, and combined with the Delphi expert consultation method for evaluation.
Read the detailed description
This project is a prospective cohort study designed to investigated the changes in blood glucose and body weight in women with gestational diabetes during pregnancy. The study aimed to enroll 4000 participants, using health management app in addition to routine prenatal care. Researchers screen subjects strictly according to the exclusion and inclusion criteria and those who interested sign the informed consent. participants completed baseline questionnaire and dietary questionnaire at app under the instruction of researchers. Pregnant women come back for follow up-visit every 2 weeks until delivery. If anyone doesn't upload the weight data for a week and doesn't respond to the phone call from the researchers, she will be regarded as lost follow-up,the number of lost follow-up cases are supplemented by increasing the enrollment. Data analysis and result output finally.
Besides, part of the study conducted in Beijing has some special points which don't exsit in large cohort study: participants equipment dynamic blood glucose monitor for glycemic control and their blood samples and stool samples will be collected at 24-28, 32 and 36 gestational weeks,respectively.
Based on the description of weight gain range of pregnant women with normal blood glucose, the influence of weight gain on adverse pregnancy outcome was analyzed, and the recommended weight gain value for women with gestational diabetes was proposed in combination with Delphi expert consultation method.
- Conditions
- Gestational Diabetes, Gestational Weight Gain
- Being tested
- prenatal care for women with GDM
- Keywords
- gestational diabetes mellitus, gestational weight gain, blood glucoes monitoring, health management, moblie health
- Medical subject headings
- Diabetes, Gestational, Gestational Weight Gain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
prenatal care for women with GDMBehavioural
we conduct prenatal care for GDM pregnancies through both prenatal clinic and app.
| Study group | Role | What they receive |
|---|---|---|
| women with GDM | After participants enrollment, we conducted follow-up visit every two weeks. Blood glucose values, body weight, life style record and clinical information are collected. Blood samples and stool samples are collected from participants in Beijing. Receives: Behavioral: prenatal care for women with GDM |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence rate of pregnancy outcomes
pregnancy outcomes including preeclampsia, gestational hypertension.
Measured: delivery
The incidence rate of infant outcomes
infant outcomes including SGA,neonatal hypoglycemia.
Measured: delivery
Secondary outcomes (1)
the value of gestational weight gain during third trimester
pregnant women with diabetes mellitus type 2,children with hypertension,obesity,diabetes,cardiovascular disease,etc.
Measured: from enrollment to delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2020
- Study start24 Mar 2020
- Primary completion30 Dec 2021 (estimated)
- Study completion30 Jun 2022 (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.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- 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
- 4,050 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Liangkun Ma, Study chair, Chinese Academy of Medical Science & Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04421053
- Sponsor's protocol ID
- JS-2333
- Status last verified
- May 2021
- First submitted
- 5 Jun 2020
- Last updated
- 21 Oct 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gestational Weight Gain (GWG) Recommendations for Chinese Women With Gestational Diabetes Mellitus (GDM)
- ClinicalTrials.gov ID
- NCT04421053
- Acronym / sponsor ID
- JS-2333
- Conditions
- Gestational Diabetes, Gestational Weight Gain
- Keywords
- gestational diabetes mellitus, gestational weight gain, blood glucoes monitoring, health management, moblie health
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 4,050 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 24 Mar 2020 (actual)
- Primary completion
- 30 Dec 2021 (estimated)
- Study completion
- 30 Jun 2022 (estimated)
- First posted
- 9 Jun 2020 (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 2009 IOM recommendation value for weight gain during pregnancy is widely used. Due to the unclear relationship between gestational diabetes mellitus and weight gain during pregnancy when formulating this recommendation value, pregnant women with gestational diabetes mellitus were excluded from the study population. Control of appropriate weight gain and control of blood glucose stability is an important part of GDM management in pregnant women. The incidence of GDM in China is about 15%-20%, and the number of pregnant women with GDM ranks first in the world. For the sake of the current and long-term health of maternal and infant, it is of great significance to explore the appropriate weight gain range and formulate the recommended value for GDM pregnant women as an independent population. This project intends to use prospective cohort study of combining the observation of pregnant women with gestational diabetes blood sugar and weight changes, through the comparison of normal pregnant women suitable scope of weight gain, analyzes its influence on adverse pregnancy outcomes, increased the weight of gestational diabetes women recommended value is put forward, and combined with the Delphi expert consultation method for evaluation.
Detailed description
This project is a prospective cohort study designed to investigated the changes in blood glucose and body weight in women with gestational diabetes during pregnancy. The study aimed to enroll 4000 participants, using health management app in addition to routine prenatal care. Researchers screen subjects strictly according to the exclusion and inclusion criteria and those who interested sign the informed consent. participants completed baseline questionnaire and dietary questionnaire at app under the instruction of researchers. Pregnant women come back for follow up-visit every 2 weeks until delivery. If anyone doesn't upload the weight data for a week and doesn't respond to the phone call from the researchers, she will be regarded as lost follow-up,the number of lost follow-up cases are supplemented by increasing the enrollment. Data analysis and result output finally.
Besides, part of the study conducted in Beijing has some special points which don't exsit in large cohort study: participants equipment dynamic blood glucose monitor for glycemic control and their blood samples and stool samples will be collected at 24-28, 32 and 36 gestational weeks,respectively.
Based on the description of weight gain range of pregnant women with normal blood glucose, the influence of weight gain on adverse pregnancy outcome was analyzed, and the recommended weight gain value for women with gestational diabetes was proposed in combination with Delphi expert consultation method.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| women with GDM | – | Behavioral: prenatal care for women with GDMAfter participants enrollment, we conducted follow-up visit every two weeks. Blood glucose values, body weight, life style record and clinical information are collected. Blood samples and stool samples are collected from participants in Beijing. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- pregnancies with gestational diabetes mellitus
Key inclusion criteria (5 listed)
- Pregnant women who have regular labor inspection and delivery in the labor inspection hospital;
- Pregnant women with gestational diabetes diagnosed by OGTT at 24 to 28 weeks of pregnancy;
- Singleton pregnancy;
- Those who can skillfully use mobile phones and other electronic devices for scientific follow-up and voluntarily record their daily weight;
- Voluntary signing of informed consent.
Key exclusion criteria (2 listed)
- Patients with pre-pregnancy diabetes mellitus or abnormal OGTT screening in early pregnancy;
- diabetic ketoacidosis,high blood sugar of high permeability anemia,leukemia, and lymphoma without clinical control.
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 |
|---|---|---|
| prenatal care for women with GDMwe conduct prenatal care for GDM pregnancies through both prenatal clinic and app. | Behavioural | women with GDM |
Primary outcome
The incidence rate of pregnancy outcomes
Time frame: delivery
pregnancy outcomes including preeclampsia, gestational hypertension.
The incidence rate of infant outcomes
Time frame: delivery
infant outcomes including SGA,neonatal hypoglycemia.
1 secondary outcome
the value of gestational weight gain during third trimester
Time frame: from enrollment to delivery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2021.
- 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.
Liangkun Ma study chair
Chinese Academy of Medical Science & Peking Union Medical College 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 and Gestational Weight Gain, run by Peking Union Medical College 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 5 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 21 Oct 2021. 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 Liangkun Ma (13021961166, MaLiangKun@pumch.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence rate of pregnancy outcomes (time frame: delivery). The study lists 2 primary outcomes in all. 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 21 Oct 2021.