Evidence map›Paper›PMID 41796294›Full record

ArticleBMC pregnancy and childbirth2026

Effectiveness of a lifestyle intervention for pregnant women with abnormal glucose metabolism in early pregnancy (EAGM): protocol for a multicentre, open-labelled, two-arm, pragmatic randomised controlled trial.

Lingyi Kong, Lixia Shen, Lepei Xie, Zhaolei Li, Caixia Zhu, Shaofeng Zhang, Yihong Huang, Zilian Wang, Haitian Chen

Registry-linked trialAbstract readClinical Trial Protocol
In one paragraph

Article in BMC pregnancy and childbirth, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06767722 (Effectiveness of a Lifestyle Intervention for Pregnant Women With Abnormal Glucose Metabolism in Early Pregnancy), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
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1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT06767722 narecruitingnot on this map

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

TypeinterventionalSponsorFirst Affiliated Hospital, Sun Yat-Sen UniversityRan2025 to 2027Enrolled3,430ConditionsEarly Pregnancy, Fasting Plasma Glucose, Hemoglobin A1c Protein, Human, Lifestyle InterventionArmsLifestyle intervention and self-monitoring of blood glucose
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors.

Lingyi Kong *Department of Obstetrics and Gynecology, The First Affiliated Hospital of Sun Yat-Sen University, Guangzhou, China.
Lixia Shen *Department of Obstetrics and Gynecology, The First Affiliated Hospital of Sun Yat-Sen University, Guangzhou, China.
Lepei XieDepartment of Obstetrics and Gynecology, The First Affiliated Hospital of Sun Yat-Sen University, Guangzhou, China.
Zhaolei LiDepartment of Obstetrics and Gynecology, The First Affiliated Hospital of Sun Yat-Sen University, Guangzhou, China.
Caixia ZhuDepartment of Obstetrics and Gynecology, The First Affiliated Hospital of Sun Yat-Sen University, Guangzhou, China.
Shaofeng ZhangDepartment of Obstetrics and Gynecology, The First Affiliated Hospital of Sun Yat-Sen University, Guangzhou, China.
Yihong HuangDepartment of Obstetrics and Gynecology, The First Affiliated Hospital of Sun Yat-Sen University, Guangzhou, China.
Zilian WangDepartment of Obstetrics and Gynecology, The First Affiliated Hospital of Sun Yat-Sen University, Guangzhou, China. wangzil@mail.sysu.edu.cn.
Haitian ChenDepartment of Obstetrics and Gynecology, The First Affiliated Hospital of Sun Yat-Sen University, Guangzhou, China. chhait@mail.sysu.edu.cn.

Funding

Major clinical projects of Guangzhou Municipality 2024P-ZD12Noncommunicable Chronic Diseases-National Science and Technology Major Project 2024ZD0532100Sun Yat-Sen University Clinical Research 5010 Program 2022004
6 · The paper itself

Abstract

introductionUniversal screening for hyperglycaemia in women without pregestational diabetes in China has led to a significant rise in the detection of abnormal glucose metabolism in early pregnancy (EAGM), defined as elevated fasting blood glucose (FPG, 5.1–6.9 mmol/L or 92–124 mg/dL) and/or haemoglobin A1c (HbA1c, 5.7%-6.4% or 41–47 mmol/mol) levels in the first trimester (< 14 weeks' gestation). EAGM is correlated with adverse pregnancy outcomes. However, whether early treatment can improve maternal and neonatal outcomes remains unclear.

methodsWe present a protocol (V1.0, date August 15, 2024) for the EAGM trial, which is a multicentre, open-labelled, two-arm, pragmatic randomised controlled trial in China. Eligible pregnancies with EAGM will be recruited from 17 hospitals. Participants (N = 3430) will be randomly allocated in a 1:1 ratio to the intervention group or the control group. The intervention group will begin early lifestyle intervention combined with routine prenatal care from < 15 weeks' gestation, while the control group will receive routine prenatal care alone. All participants will undergo an oral glucose tolerance test at 24–28 weeks' gestation, and whether to continue the intervention will depend on the test result. The primary outcome is a composite neonatal outcome of large-for-gestational-age and preterm birth at < 37 weeks' gestation. DISCUSSION: The EAGM trial is the first large-scale randomised controlled trial in China designed to evaluate the effectiveness of early lifestyle intervention for pregnant women with EAGM, identified by elevated HbA1c and/or FPG before 14 weeks' gestation. The findings are anticipated to provide high-quality evidence to guide future screening strategies and clinical management of early hyperglycaemia in pregnancy.

trial registrationClinicalTrials.gov: NCT06767722. Registered 10 January 2025.

Indexed as

HyperglycemiaLife StylePregnancy ComplicationsPrenatal CareAdultBlood GlucoseChinaFemaleGlucose Tolerance TestGlycated HemoglobinHumansMulticenter Studies as TopicPragmatic Clinical Trials as TopicPregnancyPregnancy OutcomePregnancy Trimester, FirstBlood GlucoseGlycated HemoglobinEarly PregnancyFasting Plasma GlucoseHaemoglobin A1cLifestyle InterventionPregnancy Outcomes

Identifiers

PMID41796294
PMCPMC13081433

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.