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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| calcium + vitamin D group | Experimental | Intervention for epilepsy patients |
|
| standard of care group | No Intervention | Epilepsy patients receive normal follow-up without any intervention. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Supplementation with calcium + vitamin D daily. | Drug | Test bone metabolism indicators at 10-14 weeks of pregnancy and intervene based on vitamin D levels.
|
| Measure | Description | Time Frame |
|---|---|---|
| Bone metabolisms indicators in offspring | 25-hydroxy Vitamin D (ng/ml),procollagen type 1 N-terminal propeptide (P1NP, ng/ml),osteocalcin (OC, ng/ml) | Childbirth |
| Bone metabolisms indicators in offspring | Parathyroid hormone (PTH, ng/L) | Childbirth |
| Bone metabolisms indicators in offspring | β-crosslaps (β-CTX, pg/ml) | Childbirth |
| Bone metabolisms indicators in offspring | Body length(cm) | Childbirth |
| Bone metabolisms indicators in offspring | Weight(g) | Childbirth |
| Bone metabolisms indicators in offspring | Head circumference(cm) | Childbirth |
| Measure | Description | Time Frame |
|---|---|---|
| Live birth rate without major congenital malformations (MCMs) | 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). | The outcome will be assessed at two critical time points:At Birth (Day 0-7 Post-Delivery),Within 30 Days Postnatal |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jiajia Fang | Contact | 15215880868 | fangjjiaj@zju.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Fourth Affiliated Hospital of Zhejiang University School of Medicine | Recruiting | Zhejiang | China |
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| ID | Term |
|---|---|
| D004827 | Epilepsy |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| D002118 | Calcium |
| ID | Term |
|---|---|
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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pediatricians, lab researchers, statistician
|
| Maternal Bone metabolisms indicators | 25-hydroxy Vitamin D (ng/ml),procollagen type 1 N-terminal propeptide (P1NP, ng/ml),osteocalcin (OC, ng/ml) | 12, 24, and 36 weeks of pregnancy, the time during delivery |
| Maternal Bone metabolisms indicators | β-crosslaps (β-CTX, pg/ml) | 12, 24, and 36 weeks of pregnancy, the time during delivery |
| Maternal Bone metabolisms indicators | Parathyroid hormone (PTH,ng/L) | 12, 24, and 36 weeks of pregnancy, the time during delivery |
| D008673 |
| Metals, Alkaline Earth |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D008670 | Metals |
| D001779 | Blood Coagulation Factors |
| D001685 | Biological Factors |