Clinical trial NCT06767722: Effectiveness of a Lifestyle Intervention for Pregnant Women with Abnormal Glucose Metabolism in Early Pregnancy: EAGM Randomized Controlled Trial
Official title: Effectiveness of a Lifestyle Intervention for Pregnant Women with Abnormal Glucose Metabolism in Early Pregnancy: EAGM Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Early Pregnancy
Fasting Plasma Glucose
Hemoglobin A1c Protein, Human
Lifestyle Intervention
Adverse Pregnancy Outcomes
Lead sponsor: First Affiliated Hospital, Sun Yat-Sen University
Sponsor class: OTHER
Collaborators: name: First People's Hospital of Foshan
name: Jiangmen Maternity and Child Health Care Hospital
name: Panyu Maternal And Child Care Service Centre Of Guangzhou
name: The Affiliated Shunde Hospital of Jinan University
name: Shenzhen Second People's Hospital
name: Foshan Women's and Children's Hospital
name: Guangxi Hospital Division of The First Affiliated Hospital, Sun Yat-sen University
name: Nanfang Hospital, Southern Medical University
name: BoAi Hospital of Zhongshan
name: Yuebei People's Hospital
name: Qingyuan People's Hospital
name: Dongguan Maternity & Child Health Hospital
name: The Sixth Affliated Hospital of Jinan University
name: First Affiliated Hospital of Jinan University
First posted: 2025-01-10
Enrollment: 3430
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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. We aim to assess the effectiveness of early lifestyle interventions and to provide evidence for the optimal standard management for Chinese women with EAGM.

Detailed description: Women with early abnormal glucose metabolism (EAGM) , which is defined as fasting plasma glucose (FPG) 5.1-6.9 mmol/L and/or hemoglobin A1c (HbA1c) 5.7%-6.4% at before 14 weeks of gestation, will be recruited and randomized in a 1:1 ratio into the intervention or control group. 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. The educational session is delivered as an initial session following randomization followed by five follow-up sessions which will occur approximately every four months, either face-to-face during routine prenatal visits or via telephone consultation. Routine prenatal care will also be applied to the intervention group. Women in the control group will only receive routine prenatal care. Both groups will receive an OGTT test at 24-28 weeks of gestation unless insulin is needed before the OGTT test for suboptimally controlled blood glucose levels. Whether to continue the intervention depends on the OGTT results as women diagnosed with GDM or overt diabetes will continue intervention plus routine prenatal care until delivery while those will normal OGTT result will pause interventions and follow the routine prenatal care only until delivery. The primary outcome of our trial will be a composite of neonatal outcome including large-for-gestational age and preterm birth.

Eligibility criteria: 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.

Primary outcomes:
measure: Composite neonatal outcome of large-gestational age and preterm birth
timeFrame: outcomes will be collected up to primary hospital discharge, or 28 days after the estimated date of delivery, whichever is sooner.
Secondary outcomes:
measure: Pregnancy-related hypertensive disorders
timeFrame: outcomes will be collected up to primary hospital discharge, or 28 days after the estimated date of delivery, whichever is sooner.
measure: Gestational diabetes mellitus
timeFrame: outcomes will be collected up to primary hospital discharge, or 28 days after the estimated date of delivery, whichever is sooner.
measure: Gestational hypertension
timeFrame: outcomes will be collected up to primary hospital discharge, or 28 days after the estimated date of delivery, whichever is sooner.
measure: Preeclampsia
timeFrame: outcomes will be collected up to primary hospital discharge, or 28 days after the estimated date of delivery, whichever is sooner.
measure: Eclampsia
timeFrame: outcomes will be collected up to primary hospital discharge, or 28 days after the estimated date of delivery, whichever is sooner.
measure: Prescription of hypoglycaemic drug
timeFrame: outcomes will be collected up to primary hospital discharge, or 28 days after the estimated date of delivery, whichever is sooner.
measure: Preeclampsia requiring delivery before 37 weeks
timeFrame: outcomes will be collected up to primary hospital discharge, or 28 days after the estimated date of delivery, whichever is sooner.
measure: Total gestational weight gain
timeFrame: outcomes will be collected up to primary hospital discharge, or 28 days after the estimated date of delivery, whichever is sooner.
measure: Mode of birth
timeFrame: outcomes will be collected up to primary hospital discharge, or 28 days after the estimated date of delivery, whichever is sooner.
measure: Primary caesarean
timeFrame: outcomes will be collected up to primary hospital discharge, or 28 days after the estimated date of delivery, whichever is sooner.
measure: Large-for-gestational age
timeFrame: outcomes will be collected up to primary hospital discharge, or 28 days after the estimated date of delivery, whichever is sooner.
measure: Preterm birth at <37 weeks of gestation
timeFrame: outcomes will be collected up to primary hospital discharge, or 28 days after the estimated date of delivery, whichever is sooner.
measure: Neonatal birthweight
timeFrame: outcomes will be collected up to primary hospital discharge, or 28 days after the estimated date of delivery, whichever is sooner.
measure: Small-for-gestational-age
timeFrame: outcomes will be collected up to primary hospital discharge, or 28 days after the estimated date of delivery, whichever is sooner.
measure: Gestational age at birth, weeks and days
timeFrame: outcomes will be collected up to primary hospital discharge, or 28 days after the estimated date of delivery, whichever is sooner.
measure: Neonatal hypoglycaemia
timeFrame: outcomes will be collected up to primary hospital discharge, or 28 days after the estimated date of delivery, whichever is sooner.
measure: Admission to neonatal wards or intensive care unit
timeFrame: outcomes will be collected up to primary hospital discharge, or 28 days after the estimated date of delivery, whichever is sooner.
measure: Fetal loss <24 weeks of gestation
timeFrame: outcomes will be collected up to primary hospital discharge, or 28 days after the estimated date of delivery, whichever is sooner.
measure: Fetal loss ≥24 weeks of gestation
timeFrame: outcomes will be collected up to primary hospital discharge, or 28 days after the estimated date of delivery, whichever is sooner.
measure: Termination of pregnancy
timeFrame: outcomes will be collected up to primary hospital discharge, or 28 days after the estimated date of delivery, whichever is sooner.
measure: Neonatal death
timeFrame: outcomes will be collected up to primary hospital discharge, or 28 days after the estimated date of delivery, whichever is sooner.
measure: Apgar score at 1min after birth
timeFrame: outcomes will be collected up to primary hospital discharge, or 28 days after the estimated date of delivery, whichever is sooner.
measure: Apgar score at 5min after birth
timeFrame: outcomes will be collected up to primary hospital discharge, or 28 days after the estimated date of delivery, whichever is sooner.
Other outcomes:
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