Nutritional Deficiency and Recurrent Miscarriage

Recurrent Miscarriage Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05267678
• Other study ID #: 20220215SHJ001
• Status: Recruiting
• Start date: January 28, 2023
• Est. completion date: July 1, 2024

Study information

• Verified date: May 2023
• Source: Westlake University
• Contact: Hongjun Shi, PhD
• Phone: 86-0571-85271192
• Email: shihongjun[@]westlake.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 499
• Est. completion date: July 1, 2024
• Est. primary completion date: April 1, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Abortion, Habitual
• Abortion, Spontaneous
• Malnutrition
• Recurrence
• Recurrent Miscarriage

Intervention

Other:
• No intervention
This is an observational study without any intervention

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital, Peking Union Medical College and Chinese Academy of Medical Sciences	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Westlake University	Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with miscarriage	pregnancy outcomes are confirmed by electronic hospital records or self-reported by participants	6-13(+6) weeks of gestation
Primary	Gestation week at miscarriage	pregnancy outcomes are confirmed by electronic hospital records or self-reported by participants	6-13(+6) weeks of gestation