Reducing Anemia in Pregnancy in India

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 4368

Inclusion Criteria

Inclusion Criteria for Study Consent for Initial Participation

1. Pregnant women between 18–40 years of age at time of consent that received education about the study and capable of giving informed consent

2. Hemoglobin concentration of 7 – 10.4 g/dL

3. Expressed intent and expectation of remaining in the designated research area during the pregnancy and delivering at a facility in or near the research area and remaining in the area to enable study participation and data collection consistent with the research protocol

4. Expressed willingness that specifically includes agreement to randomization to the standard care study arm (of oral iron) or to one of the two arms involving treatment with single-dose IV iron

Additional Inclusion Criteria for Randomization and Continued Study Participation:

1. Presence of a live singleton, intrauterine fetus and dating ultrasound that indicates a pregnancy that, at randomization, would be between the beginning of week 14 and prior to 17 weeks 0 days;

2. Iron deficiency anemia defined for this study as moderate anemia with hemoglobin concentration level between 7 - 9.9 g/dL and serum transferrin saturation (TSAT) is <20% and/or ferritin is <30 ng/mL

Exclusion Criteria

1. Fetal anomaly if detectable when an initial ultrasound is done to date the pregnancy (subsequent discovery of a fetal anomaly is not viewed as an exclusion criterion)

2. History of cardiovascular disease, hemoglobinopathy, or other disease or condition con-sidered a contraindication for treatment, including conditions recommended for exclusion by the manufacturers of oral or IV iron to be used in this study

3. Any condition that in the opinion of the consenting physician warrants study exclusion.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Percentage of participants who achieve Hb of more than or equal to 11 g/dL at either a 30-34 week antenatal visit or at a birthing facility (comparing each IV iron arm to the oral iron arm) <br/ ><br>2. Rate of Low birthweight (less than 2500 gram birthweight) births (comparing each IV iron arm to the oral iron arm)Timepoint: Up to delivery

Secondary Outcome Measures