Preconception vs First-Trimester Screening and Treatment for Iron Deficiency Anemia: A Cluster Randomized Trial

September 4, 2026 updated by: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

960

Phase

  • Not Applicable

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

Study Locations

  • China
    • Yunnan
      • Zhaotong, Yunnan, China, 657500
        • Recruiting
        • Yanjin County Maternal and Child Health Hospital
        • Contact:
        • Contact:
          • Peipei Hu Hu

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

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

- Women are eligible if they are aged 18-45 years, reside in a participating township, intend to attempt natural conception within the next 6 months, can complete study procedures and provide written informed consent.

Exclusion Criteria:

  • 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

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Preconception Group
Townships assigned to this group implement anemia screening and indicated iron treatment before conception.
Other: Preconception Anemia Screening and Treatment Strategy
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.
Active Comparator: Early-Pregnancy Group
Townships assigned to this group implement the same anemia screening and indicated iron treatment during early pregnancy.
Other: Early-Pregnancy Anemia Screening and Treatment Strategy
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of participants with iron deficiency anemia during late pregnancy
Time Frame: From 28 weeks' gestation to delivery
Iron deficiency anemia is defined as hemoglobin less than 110 g/L and/or serum ferritin less than 30 μg/L in the same blood sample. Participants meeting both criteria at any scheduled assessment from 28 weeks' gestation through delivery will be classified as having the primary outcome.
From 28 weeks' gestation to delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

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 (Actual)

July 10, 2026

Primary Completion (Estimated)

April 1, 2029

Study Completion (Estimated)

July 1, 2029

Study Registration Dates

First Submitted

September 4, 2026

First Submitted That Met QC Criteria

September 4, 2026

First Posted (Actual)

September 10, 2026

Study Record Updates

Last Update Posted (Actual)

September 10, 2026

Last Update Submitted That Met QC Criteria

September 4, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XHEC-C-2026-085-2

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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