A randomized controlled double-blind trial to evaluate the benefits of starting oral iron supplements in the first trimester, in reducing prevalence of anemia during pregnancy
Trial Snapshot
- Phase
- Phase 3
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 380
- Locations
- 1
- Primary Endpoint
- 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
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Permuted block randomization, fixed
- Masking
- Participant, Investigator and Outcome Assessor Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 35.00 Year(s) (—)
- Sex
- Female
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.
Outcomes
Primary Outcomes
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
Time Frame: 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
Time Frame: At the time of delivery of each woman in the study
Secondary Outcomes
- 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)