Massive study aims to tame pregnancy diabetes risks
NCT ID NCT07161947
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This study will follow 4,000 pregnant women with high blood sugar (gestational diabetes or pre-existing diabetes) to create better standards for diagnosis, treatment, and follow-up. Researchers will track health problems in mothers and babies, like preeclampsia or preterm birth, and check blood sugar levels after delivery. The goal is to improve care from before pregnancy through the postpartum period.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- What this could lead to
- If successful, this could lead to better care guidelines for managing high blood sugar during and after pregnancy, reducing health risks for mothers and babies.
- What could go wrong
- This is an observational study, not a treatment trial. It may not directly change outcomes, and results depend on accurate data collection from medical records.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 4,000 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2025
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
The study will enroll patients who receive routine prenatal care, deliver, and undergo postpartum endocrinology follow-up at any of the following four hospitals: Shanghai General Hospital; Shanghai First Maternity and Infant Hospital; Renji Hospital, Shanghai Jiao Tong University School of Medicine; and Shanghai Sixth People's Hospital Affiliated to Shanghai JiaoTong University.
- Ages
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18 years and older
- Sex
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Female participants only
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Pregnant individuals who provide written informed consent * At enrollment, meet one of the following: 1\. Gestational diabetes mellitus (GDM) diagnosed by a 75-g oral glucose tolerance test (OGTT) using Chinese Diabetes Society (CDS) 2024 thresholds (any one of: fasting plasma glucose ≥5.1 mmol/L, 1-h ≥10.0 mmol/L, or 2-h ≥8.5 mmol/L); or 2. Pre-gestational diabetes (type 1 or type 2) documented prior to pregnancy or meeting diabetes criteria at the first prenatal visit (e.g., fasting ≥7.0 mmol/L, 2-h OGTT ≥11.1 mmol/L, or HbA1c ≥6.5%); or 3. At high risk for GDM, defined a priori as ≥1 of the following: prior GDM; prior macrosomic infant (≥4,000 g); pre-pregnancy BMI ≥24 kg/m²; age ≥45 years; high-density lipoprotein cholesterol \<1 mmol/L, and/or triglyceride levels \>2.8 mmol/L; first-degree family history of diabetes; polycystic ovary syndrome (PCOS); history of coronary heart disease; chronic hypertension and repeated positive fasting urinary glucose in early pregnancy * Age ≥18 years at the time of consent * Willing and able to attend postpartum assessments (OGTT at 6 weeks, 12 months, and annually thereafter), with planned follow-up ≥3 years Exclusion Criteria: * Current or history of illicit drug use or substance abuse * Presence of an active infectious disease, including but not limited to: viral hepatitis, sexually transmitted infections or tuberculosis * Any other condition which, in the judgment of the investigator, would make the subject unsuitable for enrollment in the study
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Shanghai General Hospital, China
RECRUITINGShanghai, Shanghai Municipality, 200080, China
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