Bone Health, Epilepsy, Pregnant Woman
Conditions
Keywords
epilepsy, pregnancy
Brief summary
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.
Detailed description
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.
Interventions
DRUGSupplementation with calcium + vitamin D daily.
Test bone metabolism indicators at 10-14 weeks of pregnancy and intervene based on vitamin D levels. * For vitamin D levels \> 20 ng/ml: Supplementation with 725 mg of calcium + 500 IU of vitamin D daily. * For 10 ng/ml \< vitamin D levels ≤20 ng/ml: Supplementation with 725 mg of calcium + 900 IU of vitamin D daily. * For vitamin D levels ≤10 ng/ml: Supplementation with 725 mg of calcium + 1300 IU of vitamin D daily.
Sponsors
The Fourth Affiliated Hospital of Zhejiang University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Caregiver)
Masking description
pediatricians, lab researchers, statistician
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Diagnosis of focal or generalized epilepsy as defined by the International League Against Epilepsy. * Women of childbearing age, aged ≥18 years, planning pregnancy or in early pregnancy (≤16 weeks gestation, confirmed by last menstrual period or ultrasound) - single pregnancy. * Willing and able to provide written informed consent.
Exclusion criteria
* Pre-existing conditions affecting bone metabolism: primary hyperparathyroidism, Paget's disease, multiple myeloma, chronic kidney disease (eGFR \<60 mL/min), cirrhosis (Child-Pugh B/C), or untreated hyper/hypothyroidism. * History of metabolic complications: hypercalcemia (serum Ca²⁺ \>10.5 mg/dL), nephrolithiasis, or granulomatous diseases. * Recent/current use of bone-modifying drugs: bisphosphonates, glucocorticoids (≥5 mg/day prednisone equivalent for \>1 month), or loop diuretics within the past year. * Ultrasound shows fetal malformation. * Presence of other severe systemic diseases deemed unsuitable for study participation by the investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bone metabolisms indicators in offspring | Childbirth | 25-hydroxy Vitamin D (ng/ml)，procollagen type 1 N-terminal propeptide (P1NP, ng/ml),osteocalcin (OC, ng/ml) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Live birth rate without major congenital malformations (MCMs) | 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). |
| Maternal Bone metabolisms indicators | 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) |
Countries
China
Contacts
CONTACTJiajia Fang
Outcome results
None listed