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Nutritional Deficiency and Recurrent Miscarriage

A Cohort Study Investigating Nutritional Deficiency Among Pregnant Women With History of Recurrent Miscarriage

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05267678
Enrollment
499
Registered
2022-03-04
Start date
2023-01-28
Completion date
2024-07-01
Last updated
2023-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Recurrent Miscarriage

Brief summary

This prospective cohort study primarily aims to examine the association between blood niacin levels and recurrent miscarriage.

Detailed description

Recurrent miscarriage is affecting around 5% women at reproductive age. And the underlying causes remain undetermined in 50%-70% of cases. Although animal models and linkage analysis according to family studies have identified that niacin deficiency can lead to congenital malformations and recurrent miscarriage. Evidence based on population is lacking with regard to the effect of blood niacin levels on recurrent miscarriage. We intend to enroll 499 pregnant women confirmed by a positive blood human chorionic gonadotropin test and with history of unexplained recurrent miscarriage. By testing their blood niacin levels and following up to the end of first-trimester pregnancy, this study aims to examine the role of niacin levels in preventing miscarriages among women with history of recurrent miscarriage.

Interventions

OTHERNo intervention

This is an observational study without any intervention

Sponsors

Peking Union Medical College Hospital
CollaboratorOTHER
Westlake University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No

Inclusion criteria

* 18-40years 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Number of participants with miscarriage6-13(+6) weeks of gestationpregnancy outcomes are confirmed by electronic hospital records or self-reported by participants
Gestation week at miscarriage6-13(+6) weeks of gestationpregnancy outcomes are confirmed by electronic hospital records or self-reported by participants

Countries

China

Contacts

Primary ContactHongjun Shi, PhD
shihongjun@westlake.edu.cn86-0571-85271192
Backup ContactDanyang WANG, MPH
wangdanyang@westlake.edu.cn

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026