A clinical trial to evaluate the benefits of starting oral iron supplements in the first trimester of pregnancy in reducing the occurrence of anemia during pregnancy

Phase 3

Not yet recruiting

Conditions: Anemia complicating pregnancy, childbirth and the puerperium,

Registration Number: CTRI/2025/04/084204

Lead Sponsor: Indian Council of Medical Research (ICMR)

Brief Summary: Rationale/ gaps in existing knowledge

Iron deficiency (ID) is highly prevalent in the first trimester of pregnancy. However, current guidelines of the Anemia Mukt Bharat program in India do not recommend oral iron supplements (OIS) in the first trimester. It is unclear whether such supplementation would be beneficial to reduce iron deficiency and anemia during pregnancy. This proposal aims to address this lacuna.

Novelty

There is little Indian data on the benefits of starting OIS in the first trimester of pregnancy, instead of only in the second trimester (current national recommendations), to reduce iron deficiency and anemia during pregnancy. This is an important question to answer, given the burden of anemia in pregnancy in India.

Objectives

To compare the effectiveness of starting OIS in the first trimester versus starting it only in the second trimester, in reducing the prevalence of anemia during pregnancy.

Methods and expected outcomes

In a randomized controlled double-blind trial, pregnant women will receive either placebo or low-dose (30 mg elemental iron) OIS in the first trimester. From the second trimester onwards, they will all receive supplements as per standard of care. Participants will be monitored through pregnancy till delivery. Blood samples will be obtained in each trimester and at the time of delivery. Cord blood and placental tissue samples will also be obtained.

The proportion of women in each group with ID/anemia at delivery will be ascertained. Blood samples will be used for estimation of hematological and iron-related indices. Placental tissue will be used to determine indices related to iron homeostasis. Outcomes of pregnancy will be documented.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: Female

Target Recruitment: 380

Inclusion Criteria

Pregnant women who conceived naturally With singleton uncomplicated pregnancies Who plan to deliver their babies in CMC, Vellore Willing to be randomised to an intervention and to be followed up Those who continue till delivery, with no complications of pregnancy.

Exclusion Criteria

Those with multiple fetuses Those with any documented complication of pregnancy Those who develop any complication of pregnancy subsequently, after recruitment.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Comparison of the proportion of anemic and/or iron-deficient women among those who receive and do not receive oral iron supplements (OIS) in the first trimester	At the time of delivery of each woman in the study
2. Comparison of hematological and iron-related indices in women who receive and do not receive OIS in the first trimester	At the time of delivery of each woman in the study

Secondary Outcome Measures

Name	Time	Method
1. Comparison of hematological & iron-related indices in cord blood from women who receive & do not receive OIS in the first trimester	2.Compare iron-related parameters in placentae of a subgroup of women who receive & do not receive OIS in the first trimester

Trial Locations

Locations (1): Christian Medical College Vellore
🇮🇳
Vellore, TAMIL NADU, India
Christian Medical College Vellore
🇮🇳Vellore, TAMIL NADU, India
Dr Molly Jacob
Principal investigator
09894494337
mjacob@cmcvellore.ac.in