- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04975074
Iron Deficiency Anemia in Twin Pregnancies
July 22, 2021 updated by: Caixia Liu, Shengjing Hospital
Prospective Study of Iron Deficiency Anemia in Twin Pregnancy
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
Study Overview
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.
Study Type
Interventional
Enrollment (Anticipated)
1000
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Fang Xie
- Phone Number: 0086-457-13604210476
- Email: gougou531@hotmail.com
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 50 years (Child, Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Chinese
- Pregnant women with twin pregnancies
Exclusion Criteria:
- Single pregnancy
- Types of anemia other than iron deficiency anemia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Anemia Correction Group
Continue to take the current medication orally at the current dose
|
One of each type of iron was taken orally according to the instructions and followed every two weeks
Other Names:
|
|
Experimental: Anemia uncorrected group
Continue to take the current medication orally at the current dose
|
One of each type of iron was taken orally according to the instructions and followed every two weeks
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Routine blood
Time Frame: 2-4 weeks after antenatal care
|
Routine blood and serum ferritin(ng/ml)were checked 2-4 weeks
|
2-4 weeks after antenatal care
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
serum ferritin
Time Frame: 2-4 weeks after antenatal care
|
routine blood and serum ferritin(ng/ml)were checked 2-4 weeks
|
2-4 weeks after antenatal care
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Caixia Liu, Shengjing Hospital of CMU
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
July 15, 2021
Primary Completion (Anticipated)
December 1, 2021
Study Completion (Anticipated)
July 1, 2022
Study Registration Dates
First Submitted
June 21, 2021
First Submitted That Met QC Criteria
July 22, 2021
First Posted (Actual)
July 23, 2021
Study Record Updates
Last Update Posted (Actual)
July 23, 2021
Last Update Submitted That Met QC Criteria
July 22, 2021
Last Verified
July 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IDA in TP
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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