Nutritional Deficiency and Recurrent Miscarriage | NCT05267678

Studies
Nutritional Deficiency and Recurrent Miscarriage

NCT05267678

Sponsor

Westlake University

Status

Unknown status

Last Update Posted

Jun 1, 2023Actual

Enrollment

499Estimated

Phase

Not provided

Conditions

Recurrent Miscarriage

Interventions

No intervention

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 28, 2023Actual

Primary Completion Date

Apr 1, 2024Estimated

Completion Date

Jul 1, 2024Estimated

First Submitted Date

Feb 21, 2022

First Submission Date that Met QC Criteria

Feb 23, 2022

First Posted Date

Mar 4, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 30, 2023

Last Update Posted Date

Jun 1, 2023Actual

Name	Class
Peking Union Medical College Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

499Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Pregnant women with history of recurrent miscarriage			Other: No intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
No intervention	Other	This is an observational study without any intervention	Pregnant women with history of recurrent miscarriage

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Pregnant women with history of recurrent miscarriage

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Hongjun Shi, PhD	Contact	86-0571-85271192		shihongjun@westlake.edu.cn
Danyang WANG, MPH	Contact			wangdanyang@westlake.edu.cn

Overall Officials

Name	Affiliation	Role
Hongjun Shi, PhD	Westlake University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Peking Union Medical College Hospital, Peking Union Medical College and Chinese Academy of Medical Sciences	Recruiting	Beijing	Beijing Municipality	100730	China

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000026	Abortion, Habitual

Ancestor Terms

ID	Term
D000022	Abortion, Spontaneous
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases

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