Effectiveness of a Lifestyle Intervention for Pregnant Women With Abnormal Glucose Metabolism in Early Pregnancy: EAGM Trial

ConditionsEarly Pregnancy Fasting Plasma Glucose Hemoglobin A1c Protein, Human Lifestyle Intervention Adverse Pregnancy Outcomes

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexFemale

Age18-55

SponsorFirst Affiliated Hospital, Sun Yat-Sen University

About this trial

This is a multicentre, parallel-group, open-label, pragmatic, randomised-control trial of early lifestyle intervention versus routine prenatal care by random allocation (1:1) in women with early abnormal glucose metabolism (EAGM) to compare the incidence of large-gestational age and preterm birth between two groups. The investigators aim to assess the effectiveness of early lifestyle interventions and to provide evidence for the optimal standard management for Chinese women with EAGM.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

Lifestyle intervention and self-monitoring of blood glucose
Behavioral
The intervention will consist of a lifestyle intervention that comprises advice on diet, exercise, weight management, and self-monitoring of blood glucose (SMBG) with feedback from healthcare professionals on results and insulin treatment if indicated.

Treatment groups

3,430 Participants

are divided into 2 treatment groups

Group A: intervention groupExperimental treatment 1 intervention

Group B: control groupNo intervention 0 interventions