Iron Deficiency Anemia in Twin Pregnancies | NCT04975074

Studies
Iron Deficiency Anemia in Twin Pregnancies

NCT04975074

Sponsor

Shengjing Hospital

Status

Unknown status

Last Update Posted

Jul 23, 2021Actual

Enrollment

1,000Estimated

Phase

Phase 4

Conditions

Anemia, Iron-Deficiency

Interventions

Iron

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 2021

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

Jul 15, 2021Estimated

Primary Completion Date

Dec 2021Estimated

Completion Date

Jul 2022Estimated

First Submitted Date

Jun 21, 2021

First Submission Date that Met QC Criteria

Jul 22, 2021

First Posted Date

Jul 23, 2021Actual

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, 2021

Last Update Posted Date

Jul 23, 2021Actual

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

All pregnant women with twin pregnancies were given oral iron according to the current recommended dose. Blood routine and ferritin were monitored during pregnancy to understand the therapeutic effect of oral iron on iron deficiency anemia and iron deficiency in pregnant women with twin pregnancies

Detailed Description

All pregnant women with twin pregnancies were given oral iron according to the current recommended dose. Blood routine and ferritin were monitored every 2-4 weeks during pregnancy to understand the therapeutic effect of oral iron on iron deficiency anemia and iron deficiency in pregnant women with twin pregnancies.After delivery, we will test the neonatal ferritin and hemoglobin status. Our aim was to investigate the effects of iron supplementation during twin pregnancy on maternal and neonatal ferritin and anemia.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

1,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Anemia Correction Group	Experimental	Continue to take the current medication orally at the current dose	Drug: Iron
Anemia uncorrected group	Experimental	Continue to take the current medication orally at the current dose	Drug: Iron

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Iron	Drug	One of each type of iron was taken orally according to the instructions and followed every two weeks	Anemia Correction Group Anemia uncorrected group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Routine blood	Routine blood and serum ferritin（ng/ml）were checked 2-4 weeks	2-4 weeks after antenatal care

Secondary Outcomes

Measure	Description	Time Frame
serum ferritin	routine blood and serum ferritin（ng/ml）were checked 2-4 weeks	2-4 weeks after antenatal care

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Chinese
Pregnant women with twin pregnancies

Exclusion Criteria:

Single pregnancy
Types of anemia other than iron deficiency anemia

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

50 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Fang Xie	Contact	0086-457-13604210476		gougou531@hotmail.com

Overall Officials

Name	Affiliation	Role
Caixia Liu	Shengjing Hospital of CMU	Study Chair

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D018798	Anemia, Iron-Deficiency

Ancestor Terms

ID	Term
D000747	Anemia, Hypochromic
D000740	Anemia
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D007501	Iron
C020748	ferrous sulfate
C022943	ferrous succinate

Ancestor Terms

ID	Term
D019216	Metals, Heavy
D004602	Elements
D007287	Inorganic Chemicals
D028561	Transition Elements

Browse Leaves

Not provided

Browse Branches

Not provided