Iron Deficiency AnemiaNCT07811765
Preconception vs First-Trimester Screening and Treatment for Iron Deficiency Anemia
A study testing Preconception Anemia Screening and Treatment Strategy and Early-Pregnancy Anemia Screening and Treatment Strategy in people with Iron Deficiency Anemia, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
This cluster randomized trial compares preconception with early-pregnancy anemia screening and iron supplementation, assessing late pregnancy iron deficiency anemia and maternal and infant outcomes. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Iron Deficiency Anemia
- What is being tested?
- Preconception Anemia Screening and Treatment Strategy and Early-Pregnancy Anemia Screening and Treatment Strategy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 960 participants
- Where
- 1 siteChina
- Study dates
- 10 Jul 2026to Jul 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women aged 18-45 years
- Residence in a participating township
- Intention to attempt natural conception within 6 months after enrollment
- Ability to complete the required study procedures
- Ability and willingness to provide written informed consent
Who cannot join
- 1.Non-iron deficiency anemia or other hematologic disorders: thalassemia, sickle cell anemia, anemia of chronic disease, and other hematologic conditions will be excluded based on complete blood count findings (including hemoglobin concentration) in combination with questionnaire assessment. Renal insufficiency (eGFR <45 mL/min/1.73 m²)
- 2: hepatic insufficiency (ALT or AST >3 times the upper limit of normal)
- 3: uncontrolled heart disease (New York Heart Association [NYHA] functional class III-IV) Acute or chronic infections, including HIV infection, active tuberculosis, and uncontrolled hepatitis B Multiple pregnancy
- 4: current pregnancy complicated by major fetal malformations or chromosomal abnormalities
- 5: history or current diagnosis of preeclampsia, placental abruption, or placenta previa History of hypersensitivity to intravenous iron therapy or iron overload disorders
- 6: receipt of blood transfusion or intravenous iron therapy within 1 month before enrollment Psychiatric disorders or cognitive impairment that would interfere with study participation or compliance with study procedures
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Yanjin County Maternal and Child Health Hospital
Zhaotong, Yunnan, 657500
Guimin Huang Huang, 13608704462, 394128854@qq.com
Peipei Hu Hu
About this study
Official title: Effect of Anemia Intervention Timing (Preconception vs. First Trimester) on the Control of Iron Deficiency Anemia in the Third Trimester: A Cluster Randomized Controlled Trial
This cluster randomized trial compares preconception with early-pregnancy anemia screening and iron supplementation, assessing late pregnancy iron deficiency anemia and maternal and infant outcomes.
- Conditions
- Iron Deficiency Anemia
- Being tested
- Preconception Anemia Screening and Treatment Strategy, Early-Pregnancy Anemia Screening and Treatment Strategy
- Keywords
- Anemia Intervention Timing, Preconception, First Trimester, Iron Deficiency Anemia, Randomized Controlled Trial
- 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.
Preconception Anemia Screening and Treatment StrategyOther
Women planning pregnancy within 6 months undergo hemoglobin, hemoglobin electrophoresis, and serum ferritin assessments before conception. Those with hemoglobin levels below 120 g/L and/or serum ferritin levels below 30 μg/L receive oral ferrous succinate (0.2 g twice daily) plus vitamin C, with scheduled hematologic monitoring.
Early-Pregnancy Anemia Screening and Treatment StrategyOther
Women with a singleton pregnancy at 12 weeks' gestation who have hemoglobin levels below 110 g/L and/or serum ferritin levels below 30 μg/L will receive oral ferrous succinate (0.2 g twice daily) plus vitamin C, with scheduled hematologic monitoring
| Study group | Role | What they receive |
|---|---|---|
| Preconception Group | Experimental | Townships assigned to this group implement anemia screening and indicated iron treatment before conception. Receives: Other: Preconception Anemia Screening and Treatment Strategy |
| Early-Pregnancy Group | Active comparator | Townships assigned to this group implement the same anemia screening and indicated iron treatment during early pregnancy. Receives: Other: Early-Pregnancy Anemia Screening and Treatment Strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants with iron deficiency anemia during late pregnancy
Iron deficiency anemia is defined as a hemoglobin concentration of less than 110 g/L and a serum ferritin concentration of less than 20 μg/L, measured in the same blood sample. Participants meeting both criteria at least once during any scheduled assessment from 28 weeks' gestation through delivery will be classified as having the primary outcome.
Measured: From 28 weeks' gestation to delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2026
- Study start10 Jul 2026
- Primary completionApr 2029 (estimated)
- Study completionJul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Iron Deficiency AnemiaStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel, two-arm cluster randomized trial. Townships are randomized in a 1:1 ratio to preconception or early-pregnancy anemia screening and treatment strategies.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 960 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07811765
- Sponsor's protocol ID
- XHEC-C-2026-085-2
- Status last verified
- Aug 2026
- First submitted
- 4 Sep 2026
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- 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 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Anemia Intervention Timing (Preconception vs. First Trimester) on the Control of Iron Deficiency Anemia in the Third Trimester: A Cluster Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07811765
- Acronym / sponsor ID
- XHEC-C-2026-085-2
- Conditions
- Iron Deficiency Anemia
- Keywords
- Anemia Intervention Timing, Preconception, First Trimester, Iron Deficiency Anemia, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 960 participants (estimated)
- Lead sponsor
- Xinhua Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 10 Jul 2026 (actual)
- Primary completion
- Apr 2029 (estimated)
- Study completion
- Jul 2029 (estimated)
- First posted
- 10 Sep 2026 (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.
This cluster randomized trial compares preconception with early-pregnancy anemia screening and iron supplementation, assessing late pregnancy iron deficiency anemia and maternal and infant outcomes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel, two-arm cluster randomized trial. Townships are randomized in a 1:1 ratio to preconception or early-pregnancy anemia screening and treatment strategies.
| Arm | Type | Receives |
|---|---|---|
| Preconception Group | Experimental | Other: Preconception Anemia Screening and Treatment StrategyTownships assigned to this group implement anemia screening and indicated iron treatment before conception. |
| Early-Pregnancy Group | Active comparator | Other: Early-Pregnancy Anemia Screening and Treatment StrategyTownships assigned to this group implement the same anemia screening and indicated iron treatment during early pregnancy. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Women aged 18-45 years
- Residence in a participating township
- Intention to attempt natural conception within 6 months after enrollment
- Ability to complete the required study procedures
- Ability and willingness to provide written informed consent
Key exclusion criteria (6 listed)
- 1.Non-iron deficiency anemia or other hematologic disorders: thalassemia, sickle cell anemia, anemia of chronic disease, and other hematologic conditions will be excluded based on complete blood count findings (including hemoglobin concentration) in combination with questionnaire assessment. Renal insufficiency (eGFR <45 mL/min/1.73 m²)
- 2: hepatic insufficiency (ALT or AST >3 times the upper limit of normal)
- 3: uncontrolled heart disease (New York Heart Association [NYHA] functional class III-IV) Acute or chronic infections, including HIV infection, active tuberculosis, and uncontrolled hepatitis B Multiple pregnancy
- 4: current pregnancy complicated by major fetal malformations or chromosomal abnormalities
- 5: history or current diagnosis of preeclampsia, placental abruption, or placenta previa History of hypersensitivity to intravenous iron therapy or iron overload disorders
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 |
|---|---|---|
| Preconception Anemia Screening and Treatment StrategyWomen planning pregnancy within 6 months undergo hemoglobin, hemoglobin electrophoresis, and serum ferritin assessments before conception. Those with hemoglobin levels below 120 g/L and/or serum ferritin levels below 30 μg/L receive oral ferrous succinate (0.2 g twice daily) plus vitamin C, with scheduled hematologic monitoring. | Other | Preconception Group |
| Early-Pregnancy Anemia Screening and Treatment StrategyWomen with a singleton pregnancy at 12 weeks' gestation who have hemoglobin levels below 110 g/L and/or serum ferritin levels below 30 μg/L will receive oral ferrous succinate (0.2 g twice daily) plus vitamin C, with scheduled hematologic monitoring | Other | Early-Pregnancy Group |
Primary outcome
Proportion of participants with iron deficiency anemia during late pregnancy
Time frame: From 28 weeks' gestation to delivery
Iron deficiency anemia is defined as a hemoglobin concentration of less than 110 g/L and a serum ferritin concentration of less than 20 μg/L, measured in the same blood sample. Participants meeting both criteria at least once during any scheduled assessment from 28 weeks' gestation through delivery will be classified as having the primary outcome.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Preconception Anemia Screening and Treatment Strategy and Early-Pregnancy Anemia Screening and Treatment Strategy in people with Iron Deficiency Anemia, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
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 5 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Peipei Hu (+86-21-25076143, hupphpp@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants with iron deficiency anemia during late pregnancy (time frame: From 28 weeks' gestation to delivery). 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 17 Sep 2026; AzTrials last refreshed its copy on 26 Oct 2026.