Epidemiological Study on Anemia and Iron Deficiency in Pr... | NCT04486456

Studies
Epidemiological Study on Anemia and Iron Deficiency in Pregnancy in Medical Institutions in Some Areas of China

NCT04486456

Sponsor

Peking University First Hospital

Status

Unknown status

Last Update Posted

Jul 24, 2020Actual

Enrollment

20,000Estimated

Phase

Not provided

Conditions

Prevalence

Interventions

Not provided

Countries

Not provided

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

Jul 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2020Estimated

Primary Completion Date

Aug 2022Estimated

Completion Date

Dec 2022Estimated

First Submitted Date

Jun 16, 2020

First Submission Date that Met QC Criteria

Jul 22, 2020

First Posted Date

Jul 24, 2020Actual

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

Jul 22, 2020

Last Update Posted Date

Jul 24, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Huixia Yang, Principle investigator, Peking University First HospitalPrincipal Investigator

Lead Sponsor

Peking University First HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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

The purpose of this study is to describe the prevalence of anemia and iron deficiency in pregnancy through a multi-center, prospective follow-up study . To explore the influence factors of anemia and iron deficiency in pregnancy; to explore the influence of anemia and iron deficiency in pregnancy on maternal and fetal outcomes.

Detailed Description

To understand the epidemiological characteristics of anemia and iron deficiency in pregnancy and describe the epidemiological situation of anemia and iron deficiency.
To explore the influence factors of anemia and iron deficiency in pregnancy.
To explore the influence of anemia and iron deficiency during pregnancy on the pregnancy outcome of mothers and infants.

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

No data available

No data is available for this block.

Enrollment

20,000Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Hb	Proportion of patients with Hb<110g/L	Completed by observation，an average of 1 year

Secondary Outcomes

Measure	Description	Time Frame
SF	Proportion of patients with SF<20μg/L	Completed by observation，an average of 1 year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Regular prenatal check-ups were conducted in the hospitals participating in the study, and pregnant women who planned to give birth in hospital were established a maternity health manual
18 years and older
Patients have to agree to participate by signing a consent

Exclusion Criteria:

have severe chronic diseases with Pre-pregnancy
Suffer from severe mental illness

Accepts Healthy Volunteers

Not provided

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Pregnancy patients

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Song X Zhang	Contact	13901024399		1033341681@qq.com

Overall Officials

Name	Affiliation	Role
Xia H Yang	The First Affiliated Hospital of Peking University	Principal Investigator

Locations

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
42171390	Derived	Wang X, Zhang X, Juan J, Gao D, Yang H, Zhang M, Chen X, Wang X, Ma Y, Teng Y, Meng H, Wang X, Yang Q, Xu L, Shan S. Association of maternal longitudinal haemoglobin concentrations with adverse pregnancy outcomes: A prospective cohort study. J Glob Health. 2026 May 22;16:04168. doi: 10.7189/jogh.16.04168.
41685631	Derived

ID	Term
D019189	Iron Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases