Anemia, Iron-DeficiencyPhase 4NCT04975074
Iron Deficiency Anemia in Twin Pregnancies
A Phase 4 study testing Iron in people with Anemia, Iron-Deficiency, run by Shengjing Hospital.
Trial 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 Read more about this study
- Who is it for?
- Ages 16 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Anemia, Iron-Deficiency
- What is being tested?
- Iron
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- 15 Jul 2021to Jul 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 50 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Chinese
- Pregnant women with twin pregnancies
Who cannot join
- Single pregnancy
- Types of anemia other than iron deficiency anemia
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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
Read the 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.
- Conditions
- Anemia, Iron-Deficiency
- Being tested
- Iron
- Medical subject headings
- Anemia, Iron-Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IronDrug
Also called ferrous sulfate, polyferose, ferrous succinate, Chinese medicine filling iron agent
One of each type of iron was taken orally according to the instructions and followed every two weeks
| Study group | Role | What they receive |
|---|---|---|
| Anemia Correction Group | Experimental | Continue to take the current medication orally at the current dose Receives: Drug: Iron |
| Anemia uncorrected group | Experimental | Continue to take the current medication orally at the current dose Receives: Drug: Iron |
What is being measured
The primary outcome is the main question the study is designed to answer.
Routine blood
Routine blood and serum ferritin（ng/ml）were checked 2-4 weeks
Measured: 2-4 weeks after antenatal care
Secondary outcomes (1)
serum ferritin
routine blood and serum ferritin（ng/ml）were checked 2-4 weeks
Measured: 2-4 weeks after antenatal care
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2021
- Study start15 Jul 2021 (estimated)
- Primary completionDec 2021 (estimated)
- Study completionJul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anemia, Iron-DeficiencyStudies of the same condition, open and under way.
- More trials run by Shengjing HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shengjing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Caixia Liu, Shengjing Hospital
- Investigators
- Caixia Liu, Study chair, Shengjing Hospital of CMU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04975074
- Sponsor's protocol ID
- IDA in TP
- Status last verified
- Jul 2021
- First submitted
- 21 Jun 2021
- Last updated
- 23 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study of Iron Deficiency Anemia in Twin Pregnancy
- ClinicalTrials.gov ID
- NCT04975074
- Acronym / sponsor ID
- IDA in TP
- Conditions
- Anemia, Iron-Deficiency
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Shengjing HospitalUniversity, hospital or other
- Study start
- 15 Jul 2021 (estimated)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Jul 2022 (estimated)
- First posted
- 23 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anemia Correction Group | Experimental | Drug: IronContinue to take the current medication orally at the current dose |
| Anemia uncorrected group | Experimental | Drug: IronContinue to take the current medication orally at the current dose |
Who may qualify
- Ages
- 16 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Chinese
- Pregnant women with twin pregnancies
Key exclusion criteria (2 listed)
- Single pregnancy
- Types of anemia other than iron deficiency anemia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IronAlso: ferrous sulfate, polyferose, ferrous succinate, Chinese medicine filling iron agentOne of each type of iron was taken orally according to the instructions and followed every two weeks | Drug | Anemia Correction Group, Anemia uncorrected group |
Primary outcome
Routine blood
Time frame: 2-4 weeks after antenatal care
Routine blood and serum ferritin（ng/ml）were checked 2-4 weeks
1 secondary outcome
serum ferritin
Time frame: 2-4 weeks after antenatal care
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2021.
- Individual participant dataSharing planned: No
Related trials for Anemia, Iron-Deficiency
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life
Heart Failure With Preserved Ejection Fraction, Iron Deficiencies
Recruiting
The Effects of Iron Treatment on Vaccine Immunogenicity in Kenyan Infants With Iron Deficiency
Iron Deficiencies
RecruitingPhase 4
The Effects of Low-Dose Versus High-Dose Intravenous IRON Therapy With Ferric DerisomaltOSE in Patients With Chronic Heart Failure and Iron Deficiency
Heart Failure, Iron Deficiency
Enrolling by invitationObservational study
Long-term Impacts of Psychosocial Stimulation and Iron Supplementation
Iron Deficiency Anemia, Parenting Intervention
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Caixia Liu study chair
Shengjing Hospital of CMU
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Iron in people with Anemia, Iron-Deficiency, run by Shengjing Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fang Xie (0086-457-13604210476, gougou531@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Routine blood (time frame: 2-4 weeks after antenatal care). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2021.