Effect of Iron supplementation during pregancny on neurodevopmental status of babies

Not Applicable

• Conditions: Health Condition 1: D509- Iron deficiency anemia, unspecified

• Registration Number: CTRI/2022/05/042933
• Lead Sponsor: Childrens Investment Fund Foundation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 25 July 2023

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1 Informed consent of the RAPIDIRON Trial participant for their study inclusion and that of their offspring for the RAPIDIRON-KIDS Study

2 Expressed intent of the RAPIDIRON Trial participant to remain in the designated Karnataka research area for delivery and during the follow-up period for the RAPIDIRON-KIDS Study to enable participation in study visits

3 For the offspring â?? live-born singleton infants of Karnataka maternal participants randomized and treated in the RAPIDIRON Trial, if consent is provided by the mother and cord blood is available for analysis

Exclusion Criteria

For the offspring:

1 Non-availability of cord blood at birth to enable determination of iron indices

2 Fetal anomaly discovered after the first ultrasound of the RAPIDIRON Trial

3 Major congenital anomalies and congenital malformation of central nervous system noted at birth

4 Congenital infection

5 Moderate to severe hypoxic ischemic encephalopathy

For the RAPIDIRON Trial participant (mother):

1 Lack of availability of hemoglobin concentration from a blood sample drawn prior to delivery â?? either at the last RAPIDIRON Trial visit before delivery (visit 7 at 30-34 weeks of pregnancy) or just prior to delivery

2 Unwillingness to provide RAPIDIRON-KIDS Study consent for herself and her offspring

Study & Design

• Study Type: Observational
• Study Design: Not specified