Early lifestyle program for pregnant women with mildly high early-pregnancy blood sugar

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter, open‑label, randomized, parallel‑group trial enrolling women before 14 weeks with fasting plasma glucose 5.1–6.9 mmol/L and/or HbA1c 5.7–6.4%. Participants are randomized 1:1 to an early lifestyle intervention (diet, exercise, weight management, structured education, self‑monitoring of blood glucose with professional feedback and insulin if indicated) or to routine prenatal care. The intervention includes an initial education session plus five follow‑up contacts delivered face‑to‑face during prenatal visits or by phone, and both groups receive a 24–28 week OGTT with treatment decisions based on results. The primary outcome is a composite of neonatal outcomes including large‑for‑gestational‑age infants and preterm birth.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Over 18 years of age.
* Able to provide informed consent.
* Confirmed viable pregnancy on a nuchal translucency scan done between 11+0 and 13+6 weeks.
* Singleton pregnancies.
* An abnormal glucose metabolism determined by a blood test performed before 14 weeks, defined as FPG 5.1-6.9mmol/L and/or HbA1c 5.7-6.4%.

Exclusion Criteria:

* Pregestational diabetes (diagnosed as diabetes mellitus before pregnancy, or FPG≥7.0mmol/L, or HbA1c≥6.5% at the first prenatal visit), impaired fasting glucose or impaired glucose tolerance diagnosed before pregnancy.
* Plan for termination of pregnancy due to fetal anomaly identified at the first trimester scan.
* Use of medications known to interfere with glucose metabolism (e.g. corticosteroids, antipsychotic drugs) at the time of randomisation.
* Any other physical (serious medical conditions such as cancer, organ failure, epilepsy, paraplegia, disability) or psychological condition (e.g. learning difficulties, serious mental illness) that is likely to interfere with the conduct of the trial according to evaluation by the trial monitoring group.
* Women currently with hyperemesis gravidarum leading to dehydration or requiring hospitalization. If persisting vomiting resolves, the patient may be reassessed for inclusion in the trial up to and including 14+6 weeks of gestation, providing all other inclusion and exclusion criteria are met.

Where it's running

• The First Affiliated Hospital, Sun Yatsen University
  Guangzhou, Guangdong, China Recruiting

Study contacts

• Study coordinator: Haitian Chen, Professor
• Email: chhait@mail.sysu.edu.cn
• Phone: +8613763332296

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.