NCT Number: NCT06682663
Metabolic Dysfunction-associated Steatotic Liver Disease (MASLD) is a clinical and pathological syndrome characterized primarily by excessive intracellular fat accumulation in the liver, excluding alcohol-related and other specific causes. Recent research has identified an association between MASLD and an increased risk of pregnancy-related complications and adverse pregnancy outcomes, including gestational diabetes, preeclampsia, preterm birth, and large-for-gestational-age infants. MASLD in pregnant women poses multiple risks to maternal and infant health. Regular physical exercise during pregnancy has been shown to effectively reduce the incidence of pregnancy complications and adverse outcomes, while also alleviating hepatic steatosis and fibrosis. This study is a randomized controlled trial aimed at exploring the feasibility and effectiveness of online exercise interventions for pregnant women with MASLD, as well as conducting a cost-effectiveness analysis and investigating the underlying physiological mechanisms based on the liver-gut axis. The findings are intended to provide scientific evidence and practical recommendations for managing pregnancy health and intervening in MASLD during pregnancy.
Trial opening soon.
Get Notified20 year–45 year
Female
Interventional
Not applicable
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants try to achieve 150 minutes of moderate-vigorous training per week. The exercise program includes live streaming exercise by trained health professionals, including pregnancy-specific exercises, with professional pregnancy trainers to provide guidance and support when needed.
Time frame: Changes from the 14th week to 36 weeks + 6 days of pregnancy
LiSA, by Hepatus, Mindray, China；
Time frame: Changes from the 14th week to 36 weeks +6 days of pregnancy
E, by Hepatus, Mindray, China
Time frame: Changes from the 14th week to 36 weeks + 6 days of pregnancy
weight changes in kilograms
Time frame: Changes from the 14th week to 36 weeks + 6 days of pregnancy
All diagnoses according to the guidelines.
Time frame: Changes from the 14th week to 36 weeks + 6 days of pregnancy
All data with the routine health check-up.
Time frame: Changes from the 14th week to 36 weeks +6 days of pregnancy
with the routine check-up
Time frame: Changes from the 14th week to 36 weeks + 6 days of pregnancy
Both systolic and diastolic blood pressure are measured
Time frame: Changes from the 14th week to 36 weeks +6 days of pregnancy
Time frame: Changes from the 14th week to 36 weeks + 6 days of pregnancy
Time frame: Changes from the 14th week to 36 weeks + 6 days of pregnancy
physical activity, which collected by International Physical Activity Questionnaire Short Form，IPAQ-SF
Time frame: Changes from the 14th week to 36 weeks + 6 days of pregnancy
sleep quality, which collected by Pittsburgh Sleep Quality Questionnaire
Time frame: Changes from the 14th week to 36 weeks + 6 days of pregnancy
mental health, which collected by Generalized Anxiety Disorder-7 questionnaire， Edinburgh Pregnancy Depression Scale and Patient Health Questionnaire-9 items
Time frame: fetal data were collected from gestational week 14 to 36 week +6 days, other data collected on the delivery.
fetal height and weight, measured by ultrasonic, height in cm and weight in kg
Time frame: fetal data were collected from gestational week 14 to 36 week +6 days, other data collected on the delivery.
height, weight at birth,height measured with a rangefinder and weight measured with a scale,height in cm and weight in kg
Time frame: fetal data were collected from gestational week 14 to 36 week +6 days, other data collected on the delivery.
Apgar score，measured by clinical diagnosis
Time frame: fetal data were collected from gestational week 14 to 36 week +6 days, other data collected on the delivery.
preterm birth,clinical diagnosis
Time frame: fetal data were collected from gestational week 14 to 36 week +6 days, other data collected on the delivery.
small gestational week,clinical diagnosis
Time frame: fetal data were collected from gestational week 14 to 36 week +6 days, other data collected on the delivery.
large gestational week,clinical diagnosis
Contact information is provided by the study sponsor or research team.
Hui Wang, Ph.D
CONTACT
Mingyue Wang, MD
CONTACT
Peking University
Other
Evaluation of the Effect of Live Streaming Exercise on the Improvement of Hepatic Steatosis and Fibrosis in Pregnant Women with MASLD and Its Study Based on the Liver-gut Axis Mechanism.
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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