Bone Management in Pregnancy Outcomes in Epilepsy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Supplementation with calcium + vitamin D daily..
- Who it may be relevant to
- Registry conditions: Epilepsy, Pregnant Woman, Bone Health. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Bone Health Management on Pregnancy Outcomes in Women With Epilepsy: Randomized Study
Overview
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
- Drug Supplementation 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.
Primary outcome measures
- Bone metabolisms indicators in offspring [Time frame: Childbirth]
- Bone metabolisms indicators in offspring [Time frame: Childbirth]
- Bone metabolisms indicators in offspring [Time frame: Childbirth]
- Bone metabolisms indicators in offspring [Time frame: Childbirth]
- Bone metabolisms indicators in offspring [Time frame: Childbirth]
- Bone metabolisms indicators in offspring [Time frame: Childbirth]
Secondary outcome measures (4)
- Live birth rate without major congenital malformations (MCMs) [Time frame: The outcome will be assessed at two critical time points:At Birth (Day 0-7 Post-Delivery)，Within 30 Days Postnatal]
- Maternal Bone metabolisms indicators [Time frame: 12, 24, and 36 weeks of pregnancy, the time during delivery]
- Maternal Bone metabolisms indicators [Time frame: 12, 24, and 36 weeks of pregnancy, the time during delivery]
- Maternal Bone metabolisms indicators [Time frame: 12, 24, and 36 weeks of pregnancy, the time during delivery]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- The Fourth Affiliated Hospital of Zhejiang University School of Medicine — Zhejiang
Identifiers
NCT: NCT07651709 · KY-2022-051