NCT07651709Recruiting
Bone Management in Pregnancy Outcomes in Epilepsy
Bone Health Management on Pregnancy Outcomes in Women With Epilepsy: Randomized Study
Source: ClinicalTrials.gov · Last updated 16 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 80 (estimated)
- First submitted
- 17 Apr 2026
- Start date
- Jun 2026
- Primary completion date
- Jan 2035
- Lead sponsor
- The Fourth Affiliated Hospital of Zhejiang University School of Medicine
- Diseases
- Epilepsy
- NCT number
- NCT07651709
What you commit to
- Study type: Interventional
- Planned participants: 80
- From Jun 2026 to the primary completion date, Jan 2035
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Recent/current use of bone-modifying drugs: bisphosphonates, glucocorticoids (≥5 mg/day prednisone equivalent for \>1 month), or loop diuretics within the past year.
Other illness
- Presence of other severe systemic diseases deemed unsuitable for study participation by the investigator.
Lab values
- 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.
Other
- Ultrasound shows fetal malformation.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: Female · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Fourth Affiliated Hospital of Zhejiang University School of Medicine Coordinator of this site? Confirm its status | Zhejiang | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.