Nutritional Deficiency and Recurrent Miscarriage
A Cohort Study Investigating Nutritional Deficiency Among Pregnant Women With History of Recurrent Miscarriage
1 other identifier
observational
499
1 country
1
Brief Summary
This prospective cohort study primarily aims to examine the association between blood niacin levels and recurrent miscarriage.
Trial Health
Trial Health Score
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participants targeted
Target at P75+ for all trials
Started Jan 2023
1 active site
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 21, 2022
CompletedFirst Posted
Study publicly available on registry
March 4, 2022
CompletedStudy Start
First participant enrolled
January 28, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2024
CompletedJune 1, 2023
May 1, 2023
1.2 years
February 21, 2022
May 30, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
Number of participants with miscarriage
pregnancy outcomes are confirmed by electronic hospital records or self-reported by participants
6-13(+6) weeks of gestation
Gestation week at miscarriage
pregnancy outcomes are confirmed by electronic hospital records or self-reported by participants
6-13(+6) weeks of gestation
Study Arms (1)
Pregnant women with history of recurrent miscarriage
Interventions
This is an observational study without any intervention
Eligibility Criteria
Pregnant women with history of recurrent miscarriage
You may qualify if:
- years old, female
- Positive blood human chorionic gonadotropin test
- Naturally pregnant
- History of recurrent miscarriage (2 or more consecutive spontaneous miscarriage within 28 weeks of gestation)
- Willing to participate in this study with informed consent
You may not qualify if:
- Women whose confirmed cause of recurrent miscarriage has nothing to do with nutritional deficiencies, including chromosomal abnormalities, abnormal uterine anatomy, immune system diseases, blood diseases, etc.
- Women with Hepatitis B, syphilis, HIV/AIDS and other infectious diseases.
- Women with serious conditions, such as schizophrenia, tumors, heart failure
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Westlake Universitylead
- Peking Union Medical College Hospitalcollaborator
Study Sites (1)
Peking Union Medical College Hospital, Peking Union Medical College and Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100730, China
Biospecimen
Maternal blood during pregnancy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hongjun Shi, PhD
Westlake University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 21, 2022
First Posted
March 4, 2022
Study Start
January 28, 2023
Primary Completion
April 1, 2024
Study Completion
July 1, 2024
Last Updated
June 1, 2023
Record last verified: 2023-05