NCT04975074

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jul 2021

Shorter than P25 for phase_4

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 21, 2021

Completed
24 days until next milestone

Study Start

First participant enrolled

July 15, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 23, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2022

Completed
Last Updated

July 23, 2021

Status Verified

July 1, 2021

Enrollment Period

5 months

First QC Date

June 21, 2021

Last Update Submit

July 22, 2021

Conditions

Anemia, Iron-Deficiency

Outcome Measures

Primary Outcomes (1)

  • Routine blood

    Routine blood and serum ferritin（ng/ml）were checked 2-4 weeks

    2-4 weeks after antenatal care

Secondary Outcomes (1)

  • serum ferritin

    2-4 weeks after antenatal care

Study Arms (2)

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

IronDRUG

One of each type of iron was taken orally according to the instructions and followed every two weeks

Also known as: ferrous sulfate, polyferose, ferrous succinate, Chinese medicine filling iron agent
Anemia Correction GroupAnemia uncorrected group

Eligibility Criteria

Age16 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Chinese
  • Pregnant women with twin pregnancies

You may not qualify if:

  • Single pregnancy
  • Types of anemia other than iron deficiency anemia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Anemia, Iron-Deficiency

Interventions

Ironferrous sulfateferrous succinate

Condition Hierarchy (Ancestors)

Anemia, HypochromicAnemiaHematologic DiseasesHemic and Lymphatic DiseasesIron DeficienciesIron Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Metals, HeavyElementsInorganic ChemicalsTransition ElementsMetals

Study Officials

  • Caixia Liu

    Shengjing Hospital of CMU

    STUDY CHAIR

Central Study Contacts

Fang Xie

CONTACT

0086-457-13604210476gougou531@hotmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

June 21, 2021

First Posted

July 23, 2021

Study Start

July 15, 2021

Primary Completion

December 1, 2021

Study Completion

July 1, 2022

Last Updated

July 23, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share