Clinical trial NCT06002035: Study on Clinical Value of Vitamin D in Recurrent Spontaneous Abortion
Official title: The Role and Mechanism of Vitamin D in Recurrent Spontaneous Abortion Based on Maternal Fetal Interface Immune Tolerance
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vitamin D Deficiency
Recurrent Spontaneous Abortion
Lead sponsor: First People's Hospital of Hangzhou
Sponsor class: OTHER
First posted: 2023-08-21
Enrollment: 1421
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Women of childbearing age visited the RSA specialty clinic of Hangzhou First People's Hospital from January 2021 to June 2023, conducting a prospective clinical study.

Brief summary: The observational study is to compare vitamin D deficiency and related indicators among different spontaneous abortions in describe female reproductive health.The main question aim to answer is: the possible pathogenesis of recurrent spontaneous abortion caused by vitamin D.

Participants, who visit the RSA specialty clinic, will provide medical history information, regularly exam based on the condition, following up on pregnancy status.Participants will be asked to supply vitamin D preparation and do moderate exercise outdoors, comparing the effect after treatment.

Detailed description: Examinations include uterine artery resistance parameter S/D, some embryonic chromosomes tested voluntarily, plasma VD content and the level of anticardiolipin antibody.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of patients without spontaneous abortion;
* Clinical diagnosis of patients with a spontaneous abortion;
* Clinical diagnosis of patients with recurrent pontaneous abortions;

Exclusion Criteria:

* Patients with chromosomal abnormalities in RSA couples, such as balanced translocation;
* Patients who take VD preparations or related VD supplements within 3 months before treatment;
* Patients with a combination of certain malignant tumors and severe mental illness.

Primary outcomes:
measure: Rate of the effect of vitamin D supplementation on adverse pregnancy outcomes1
timeFrame: average of 1 year
measure: Rate of the effect of vitamin D supplementation on adverse pregnancy outcomes2
timeFrame: average of half of a year
measure: Rate of the effect of vitamin D supplementation on adverse pregnancy outcomes3
timeFrame: average of half of a year
measure: Rate of the effect of vitamin D supplementation on adverse pregnancy outcomes4
timeFrame: average of half of a year
measure: Rate of the effect of vitamin D supplementation on adverse pregnancy outcomes5
timeFrame: average of half of a year
Secondary outcomes:
measure: The difference of age in different number of spontaneous abortions
timeFrame: one day
measure: The difference of BMI in different number of spontaneous abortion
timeFrame: one day
measure: The difference of uterine artery resistance parameter S/D in different number of spontaneous abortions
timeFrame: dynamic monitoring, average of half of a year
measure: The abnormality of some embryonic chromosomes tested voluntarily in spontaneous abortions
timeFrame: a month
measure: The change of plasma VD content in spontaneous abortions before and after supplying vitamin D
timeFrame: average of 1 year
measure: The change of the level of plasma anticardiolipin antibody in spontaneous abortions before and after supplying vitamin D
timeFrame: average of 1 year
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Jianmei Xia
state: Zhejiang
Study officials:
affiliation: First People's Hospital of Hangzhou
name: Jianmei Xia
role: STUDY_DIRECTOR
References: