The Fourth Affiliated Hospital of Zhejiang University School of Medicine
Zhejiang, China
Location status: Recruiting
NCT Number: NCT07651709
This study is aimed to evaluate the efficacy of bone health management in improving pregnancy outcomes among WWE, and establish evidence-based vitamin D supplementation strategies for childbearing-age WWE.
Interested in participating?
Request Info18 year and older
Female
Interventional
Not applicable
Zhejiang, China
Location status: Recruiting
Epilepsy, a common neurological disorder, affects approximately over 70 million individuals worldwide and 0.5-1% of women of childbearing age. Management of women with epilepsy (WWE) during their pregnancy period presents significant challenges. Optimal bone metabolism management is an essential component of obstetric care. To evaluate the efficacy of bone health management in improving pregnancy outcomes among WWE, and establish evidence-based vitamin D supplementation strategies for childbearing-age WWE. Based on the vitamin D levels of pregnant women with epilepsy during the early stage of pregnancy, intervention measures were taken to supplement vitamin D. The bone metabolism indicators of the offspring were tested.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Test bone metabolism indicators at 10-14 weeks of pregnancy and intervene based on vitamin D levels.
Time frame: Childbirth
25-hydroxy Vitamin D (ng/ml),procollagen type 1 N-terminal propeptide (P1NP, ng/ml),osteocalcin (OC, ng/ml)
Time frame: Childbirth
Parathyroid hormone (PTH, ng/L)
Time frame: Childbirth
β-crosslaps (β-CTX, pg/ml)
Time frame: Childbirth
Body length(cm)
Time frame: Childbirth
Weight(g)
Time frame: Childbirth
Head circumference(cm)
Time frame: The outcome will be assessed at two critical time points:At Birth (Day 0-7 Post-Delivery),Within 30 Days Postnatal
Live Birth Definition: Delivery of a fetus showing any sign of life at ≥20 weeks of gestation (WHO criteria).
Major Congenital Malformations (MCMs) definition: Structural or functional abnormalities present at birth (modified from EUROCAT criteria).
Time frame: 12, 24, and 36 weeks of pregnancy, the time during delivery
25-hydroxy Vitamin D (ng/ml),procollagen type 1 N-terminal propeptide (P1NP, ng/ml),osteocalcin (OC, ng/ml)
Time frame: 12, 24, and 36 weeks of pregnancy, the time during delivery
β-crosslaps (β-CTX, pg/ml)
Time frame: 12, 24, and 36 weeks of pregnancy, the time during delivery
Parathyroid hormone (PTH,ng/L)
Contact information is provided by the study sponsor or research team.
The Fourth Affiliated Hospital of Zhejiang University School of Medicine
Other
Bone Health Management on Pregnancy Outcomes in Women With Epilepsy: Randomized Study
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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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