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.
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.
Study Type
OBSERVATIONAL
Enrollment
344
Continuous use of LMWH for more than 3 months during pregnancy preparation and through pregnancy
Renji Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China
RECRUITINGultrasound BMD before medication during pregnancy preparation
use ultrasound to test heel bone mineral density before medication during pregnancy preparation
Time frame: 4 weeks
ultrasound BMD after medication during pregnancy preparation
use ultrasound to test heel bone mineral density after medication during pregnancy preparation
Time frame: up to 16 weeks
ultrasound BMD at 10th weeks of pregnancy
use ultrasound to test heel bone mineral density at 10th weeks of pregnancy
Time frame: up to 26 weeks
ultrasound BMD at 24th weeks of pregnancy
use ultrasound to test heel bone mineral density at 24th weeks of pregnancy
Time frame: 40 weeks
ultrasound BMD at 32nd weeks of pregnancy
use ultrasound to test heel bone mineral density at 32nd weeks of pregnancy
Time frame: 1 year
ultrasound BMD at postpartum
use ultrasound to test heel bone mineral density at postpartum
Time frame: up to 1 year and 2 months
osteocalcin before medication during pregnancy preparation
use peripheral blood test to detect N-terminal mid-molecular fragment of serum osteocalcin before medication during pregnancy preparation
Time frame: 4 weeks
osteocalcin after medication during pregnancy preparation
use peripheral blood test to detect N-terminal mid-molecular fragment of serum osteocalcin after medication during pregnancy preparation
Time frame: up to 16 weeks
osteocalcin at 10th weeks of pregnancy
use peripheral blood test to detect N-terminal mid-molecular fragment of serum osteocalcin at 10th weeks of pregnancy
Time frame: up to 26 weeks
osteocalcin at 24th weeks of pregnancy
use peripheral blood test to detect N-terminal mid-molecular fragment of serum osteocalcin at 24th weeks of pregnancy
Time frame: 40 weeks
osteocalcin at 32nd weeks of pregnancy
use peripheral blood test to detect N-terminal mid-molecular fragment of serum osteocalcin at 32nd weeks of pregnancy
Time frame: 1 year
osteocalcin at postpartum
use peripheral blood test to detect N-terminal mid-molecular fragment of serum osteocalcin at postpartum
Time frame: up to 1 year and 2 months
calcium before medication during pregnancy preparation
use peripheral blood test to detect calcium level before medication during pregnancy preparation
Time frame: 4 weeks
calcium after medication during pregnancy preparation
use peripheral blood test to detect calcium level after medication during pregnancy preparation
Time frame: up to 16 weeks
calcium at 10th weeks of pregnancy
use peripheral blood test to detect calcium level at 10th weeks of pregnancy
Time frame: up to 26 weeks
calcium at 24th weeks of pregnancy
use peripheral blood test to detect calcium level at 24th weeks of pregnancy
Time frame: 40 weeks
calcium at 32nd weeks of pregnancy
use peripheral blood test to detect calcium level at 32nd weeks of pregnancy
Time frame: 1 year
calcium at postpartum
use peripheral blood test to detect calcium level at postpartum
Time frame: up to 1 year and 2 months
PTH before medication during pregnancy preparation
use peripheral blood test to detect parathyroid hormone level before medication during pregnancy preparation
Time frame: 4 weeks
PTH after medication during pregnancy preparation
use peripheral blood test to detect parathyroid hormone level after medication during pregnancy preparation
Time frame: up to 16 weeks
PTH at 10th weeks of pregnancy
use peripheral blood test to detect parathyroid hormone level at 10th weeks of pregnancy
Time frame: up to 26 weeks
PTH at 24th weeks of pregnancy
use peripheral blood test to detect parathyroid hormone level at 24th weeks of pregnancy
Time frame: 40 weeks
PTH at 32nd weeks of pregnancy
use peripheral blood test to detect parathyroid hormone level at 32nd weeks of pregnancy
Time frame: 1 year
PTH at postpartum
use peripheral blood test to detect parathyroid hormone level at postpartum
Time frame: up to 1 year and 2 months
live bitrh
A live baby born after 23 weeks of gestation
Time frame: 1 year
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