Nutritional Deficiency and Recurrent Miscarriage

Recruiting

• Conditions: Recurrent Miscarriage
• Interventions: Other: No intervention

• Registration Number: NCT05267678
• Lead Sponsor: Westlake University

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.

Study Timeline

• Study First Submitted: 2022-02-21
• Study First Submitted QC: 2022-02-23
• Study First Posted: 2022-03-04
• Study Start: 2023-01-28
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-30
• Last Update Posted: 2023-06-01
• Primary Completion: 2024-04-01
• Study Completion: 2024-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 499

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pregnant women with history of recurrent miscarriage	No intervention	-

Primary Outcome Measures

Name	Time	Method
Number of participants with miscarriage	6-13(+6) weeks of gestation	pregnancy outcomes are confirmed by electronic hospital records or self-reported by participants
Gestation week at miscarriage	6-13(+6) weeks of gestation	pregnancy outcomes are confirmed by electronic hospital records or self-reported by participants

Trial Locations

Locations (1)

Peking Union Medical College Hospital, Peking Union Medical College and Chinese Academy of Medical Sciences; 🇨🇳 Beijing, Beijing, China