Back to resultsIron Deficiency Anemia in Twin Pregnancies
Primary Purpose
Anemia, Iron-Deficiency
Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Iron
Sponsored by
About this trial
This is an interventional prevention trial for Anemia, Iron-Deficiency
Eligibility Criteria
Inclusion Criteria:
- Chinese
- Pregnant women with twin pregnancies
Exclusion Criteria:
- Single pregnancy
- Types of anemia other than iron deficiency anemia
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Anemia Correction Group
Anemia uncorrected group
Arm Description
Continue to take the current medication orally at the current dose
Continue to take the current medication orally at the current dose
Outcomes
Primary Outcome Measures
Routine blood
Routine blood and serum ferritin（ng/ml）were checked 2-4 weeks
Secondary Outcome Measures
serum ferritin
routine blood and serum ferritin（ng/ml）were checked 2-4 weeks
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04975074
Brief Title
Iron Deficiency Anemia in Twin Pregnancies
Official Title
Prospective Study of Iron Deficiency Anemia in Twin Pregnancy
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
July 15, 2021 (Anticipated)
Primary Completion Date
December 2021 (Anticipated)
Study Completion Date
July 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shengjing Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anemia, Iron-Deficiency
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
1000 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Anemia Correction Group
Arm Type
Experimental
Arm Description
Continue to take the current medication orally at the current dose
Arm Title
Anemia uncorrected group
Arm Type
Experimental
Arm Description
Continue to take the current medication orally at the current dose
Intervention Type
Drug
Intervention Name(s)
Iron
Other Intervention Name(s)
ferrous sulfate, polyferose, ferrous succinate, Chinese medicine filling iron agent
Intervention Description
One of each type of iron was taken orally according to the instructions and followed every two weeks
Primary Outcome Measure Information:
Title
Routine blood
Description
Routine blood and serum ferritin（ng/ml）were checked 2-4 weeks
Time Frame
2-4 weeks after antenatal care
Secondary Outcome Measure Information:
Title
serum ferritin
Description
routine blood and serum ferritin（ng/ml）were checked 2-4 weeks
Time Frame
2-4 weeks after antenatal care
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Chinese
Pregnant women with twin pregnancies
Exclusion Criteria:
Single pregnancy
Types of anemia other than iron deficiency anemia
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fang Xie
Phone
0086-457-13604210476
Email
gougou531@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Caixia Liu
Organizational Affiliation
Shengjing Hospital of CMU
Official's Role
Study Chair
12. IPD Sharing Statement
Plan to Share IPD
No
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Iron Deficiency Anemia in Twin Pregnancies
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