Nutritional Deficiency and Recurrent Miscarriage

Westlake University

Status: Enrolling

Conditions: Recurrent Miscarriage

Treatments: Other: No intervention

Study type: Observational

Funder types: Other

Identifiers

NCT05267678

20220215SHJ001

Details and patient eligibility

About

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

Full 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.

Enrollment: 499 estimated patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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

Trial design

499 participants in 1 patient group

Pregnant women with history of recurrent miscarriage

Treatment:

Other: No intervention