An observational study in Vitamin D Deficiency, Recurrent Miscarriage and Pregnancy Related, sponsored by Aimin Zhao. Status unknown at 1 site in China. Open to female participants aged 20 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-04-24.
Sponsored by Aimin Zhao · Observational
The objective of this single-center prospective observational study is to clarify the trend of maternal serum 25(OH)D levels before pregnancy and during pregnancy, and to explore the correlation between serum 25(OH)D levels and subsequent pregnancy outcomes of patients with abortion, so as to provide certain scientific evidence for finding the optimal serum level of 25(OH)D and optimal vitamin D supplementation to maintain a healthy pregnancy.
Women of reproductive age who meet the inclusion criteria are recruited from the outpatient department of Renji Hospital from November 2022 to December 2023. Subjects fill in the basic information at the outpatient clinic. After being included in the study, peripheral blood is collected before and during the first trimester (\< 10 weeks), second trimester (22-24 weeks) and third trimester (32 weeks) to detect 25(OH)D, calcium, phosphorus and PTH levels. B-ultrasound examination is performed before pregnancy to record endometrial thickness, endometrial hemodynamic index (PI, RI and S/D) and uterine arterial hemodynamic index (PI, RI and S/D) during the luteal phase. Data are comprehensively analyzed through questionnaire form filling, laboratory examination, and clinical information records including pregnancy outcomes (final live birth rate, cesarean section rate, pregnancy loss rate, etc.), obstetric complications, and neonatal delivery information.
320 studies on the registry are indexed under Abortion, Spontaneous; 53 are open to participants now.
This study's planned enrollment of 171 is below the median of 200 across 140 observational studies indexed under Abortion, Spontaneous.
Browse Abortion, Spontaneous studies →Aimin Zhao is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
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Women of childbearing age who are ready to become pregnant or already pregnant.
Exclusion Criteria:
Subjects in this study are grouped according to baseline serum levels of 25(OH)D. The serum level of total 25(OH)D ≥30ng/ml (75nM) is sufficient, 20-30ng/ml (50-75 nm) is insufficient, and less than 20ng/ml (50nM) is deficient.
pregnancy loss
After a positive urinary hCG pregnancy test at home or clinically, there were no clinical signs of pregnancy on subsequent ultrasound or signs of pregnancy were lost after ultrasound confirmation.
Time frame: Up to 28 weeks
Live birth
A live baby born after 23 weeks of gestation
Time frame: Up to 20 weeks
Premature birth
Delivery between 28 and 37 weeks gestation
Time frame: 9 weeks
Preeclampsia
New hypertension (blood pressure greater than 140/90 mmHg) after 20 weeks of gestation combined with new unexplained urinary protein greater than or equal to 300mg/24h or a urinary protein/creatinine ratio greater than or equal to 0.3 or other conditions
Time frame: 20 weeks
Gestational diabetes mellitus
Perform a 75-g OGTT with plasma glucose measurement when patient is fasting and at 1 and 2 h, at 24-to-28-wk gestation in women not previously diagnosed with overt diabetes The diagnosis of GDM is made when any one of the following plasma glucose values are met or exceeded: Fasting: 92 mg/dL 1. h: 180 mg/dL 2. h: 153 mg/dL
Time frame: 4 weeks
Fetal growth restriction
Fetal weight below the 10th percentile of the mean weight for its gestational age or below 2 standard deviations of the mean weight
Time frame: Up to 28 weeks
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
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Aimin Zhao