Effect of Early Lifestyle Intervention on Perinatal Outcomes in High-risk Women for Gestational Hyperglycemia

ConditionGDM
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorTianjin Central Hospital of Gynecology Obstetrics

About this trial

This study aims to explore whether early intervention for high-risk groups of gestational hyperglycemia can improve insulin resistance and effectively prevent the occurrence of GDM, and evaluate which pathophysiological subtypes of GDM have the best effect on improving maternal and fetal adverse prognosis, so as to provide evidence for stratified management and individualized clinical intervention of high glucose groups in pregnancy

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

18-55 years old

6-14 weeks of pregnancy

at least one risk factor for GDM

signed a written informed consent

Disqualifiers

Individuals diagnosed with diabetes or prediabetes prior to pregnancy

currently taking medications affecting blood glucose levels such as metformin

women at risk of miscarriage

individuals with chronic conditions (such as uncontrolled hypertension, severe heart disease)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Individual lifestyle management

    Behavioral

    Manage the diet, exercise, weight and healthy lifestyle of pregnant women

Treatment groups

604 Participants
are divided into 2 treatment groups
Group A: Intervention GroupExperimental treatment 1 intervention
Group B: control groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

The incidence of gestational diabetes(GDM)

The 75g 2h oral glucose tolerance test is performed at 24-28 weeks of gestation, and the cut-off points of venous blood glucose values are 5.1mmol/L (fasting), 10.0mmol/L (1h after glucose load), 8.5mmol/L (2h after glucose load). If any one of the three blood glucose measures is above the cut-off points, then GDM is diagnosed..

Time frame
24-28 weeks pregnant

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: