NCT07651709 Bone Management in Pregnancy Outcomes in Epilepsy
| NCT ID | NCT07651709 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The Fourth Affiliated Hospital of Zhejiang University School of Medicine |
| Condition | Epilepsy |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2026-06 |
| Primary Completion | 2035-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 80 participants in total. It began in 2026-06 with a primary completion date of 2035-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07651709 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Epilepsy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07651709 currently recruiting?
Yes, NCT07651709 is actively recruiting participants. Contact the research team at fangjjiaj@zju.edu.cn for enrollment information.
Where is the NCT07651709 trial being conducted?
This trial is being conducted at Zhejiang, China.
Who is sponsoring the NCT07651709 clinical trial?
NCT07651709 is sponsored by The Fourth Affiliated Hospital of Zhejiang University School of Medicine. The trial plans to enroll 80 participants.
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