Prospective Cohort Study of Bone Mineral Density and Calcium-phosphorus Metabolism in RSA Patients: Low Molecular Weight Heparin Use Versus Control
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 344
- 试验地点
- 1
- 主要终点
- ultrasound BMD at 24th weeks of pregnancy
研究概览
简要总结
The goal of this prospective observational study is to learn about the effect of low molecular weight heparin (LMWH) application on bone mineral density (BMD) and on calcium-phosphorus metabolism in patients with recurrent spontaneous abortion (RSA), and to compare the degree of bone loss and changes in blood calcium and phosphorus in RSA patients and in control groups with normal pregnancy. By monitoring ultrasound BMD and serum indicators related to maternal bone formation and Ca-P metabolism, the association mechanism between long-term use of LMWH, maternal Ca-P regulation and bone loss will be constructed, so as to contribute to clinical treatment and lifestyle guidance during pregnancy in RSA patients.
详细描述
Women who meet the inclusion criteria at the outpatient clinic of Renji Hospital are recruited in this study from November 2022 to December 2023. Basic information of all subjects is recorded, including number of miscarriages, duration of breastfeeding, comorbidities, and intake of nutritional supplements. Subjects' medication use during the study is recorded as well. Subjects will undergo ultrasound BMD at six time points: before and after medication during pregnancy preparation, at 10, 24, 32 weeks of pregnancy, and at 42 days postpartum. Peripheral blood will also be collected at the time points above to measure serum osteocalcin, blood calcium, blood phosphorus, 25(OH) D, thyroid hormone, and parathyroid hormone levels. Subjects will be followed up to 42 days postpartum to observe pregnancy outcomes and health conditions of the newborn.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age between 18 to 45 years.
- •Female who needs to prepare for pregnancy or have a confirmed pregnancy
- •normal karyotype of chromosomes.
- •normal uterine anatomy under pelvic ultrasound examination.
- •Cooperation in completing blood sample collection, testing and ultrasound examination.
- •no serious medical or surgical comorbidities.
- •Sign the informed consent form.
排除标准
- •Presence of diseases affecting calcium metabolism, including primary hyperparathyroidism, Cushing's disease, chronic liver, kidney and gastrointestinal (e.g., celiac disease) disorders and rheumatoid arthritis.
- •Known HIV positive and / or screening visit, HBsAg or HCV antibody positive.
- •The malignant tumors occurred in the past 5 years (except for the skin squamous basal cell carcinoma which has been resected and considered cured). Subjects who developed malignancies five years ago should provide evidence of remission or cure. Subjects with a history of cervical cancer who had undergone conization or cure in the past 3 years were eligible.
- •Patients with a history of chronic infection such as Mycoplasma, chlamydia, Cryptococcus and invasive fungal infection should be discussed with the main researchers.
- •History of active tuberculosis (TB) or evidence of previous TB infection. Subjects with a history of potential TB infection should also be excluded, unless there is a documented evidence that they have completed appropriate anti TB treatment in accordance with CDC guidelines or local regulations before screening. In addition, subjects were strictly forbidden to have any clinical symptoms / signs of active TB.
- •Presence of pregnancy contraindications.
研究组 & 干预措施
LMWH group
Continuous use of low molecular weight heparin for more than 3 months during pregnancy preparation and during pregnancy with a history of more than 2 consecutive miscarriages before 28 weeks of gestation
干预措施: Low molecular weight heparin (Drug)
结局指标
主要结局
ultrasound BMD at 24th weeks of pregnancy
时间窗: 40 weeks
use ultrasound to test heel bone mineral density at 24th weeks of pregnancy
ultrasound BMD at postpartum
时间窗: up to 1 year and 2 months
use ultrasound to test heel bone mineral density at postpartum
ultrasound BMD after medication during pregnancy preparation
时间窗: up to 16 weeks
use ultrasound to test heel bone mineral density after medication during pregnancy preparation
ultrasound BMD at 10th weeks of pregnancy
时间窗: up to 26 weeks
use ultrasound to test heel bone mineral density at 10th weeks of pregnancy
ultrasound BMD before medication during pregnancy preparation
时间窗: 4 weeks
use ultrasound to test heel bone mineral density before medication during pregnancy preparation
ultrasound BMD at 32nd weeks of pregnancy
时间窗: 1 year
use ultrasound to test heel bone mineral density at 32nd weeks of pregnancy
次要结局
- osteocalcin at 24th weeks of pregnancy(40 weeks)
- osteocalcin at postpartum(up to 1 year and 2 months)
- calcium after medication during pregnancy preparation(up to 16 weeks)
- calcium at 32nd weeks of pregnancy(1 year)
- calcium at 10th weeks of pregnancy(up to 26 weeks)
- PTH at 24th weeks of pregnancy(40 weeks)
- osteocalcin before medication during pregnancy preparation(4 weeks)
- osteocalcin after medication during pregnancy preparation(up to 16 weeks)
- osteocalcin at 10th weeks of pregnancy(up to 26 weeks)
- osteocalcin at 32nd weeks of pregnancy(1 year)
- calcium at 24th weeks of pregnancy(40 weeks)
- PTH after medication during pregnancy preparation(up to 16 weeks)
- PTH at 10th weeks of pregnancy(up to 26 weeks)
- calcium before medication during pregnancy preparation(4 weeks)
- calcium at postpartum(up to 1 year and 2 months)
- PTH at 32nd weeks of pregnancy(1 year)
- PTH before medication during pregnancy preparation(4 weeks)
- live bitrh(1 year)
- PTH at postpartum(up to 1 year and 2 months)
研究者
Aimin Zhao
Director of Obstetrics and Gynecology
RenJi Hospital