MedPath

A clinical trial to evaluate the effects of iron therapy in term newborns.

Phase 3
Completed
Registration Number
CTRI/2016/09/007242
Lead Sponsor
Assam medical college
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
200
Inclusion Criteria

All mothers admitted in labour room or planned for cesarean section will be screened for eligibility.

1)pregnant women are eligible if they meet the following criteria;non-smoking,no known hemolytic disease(sickle cell disease/Hb E disease),no treatment with with any of the drugs like anticonvulsants,antidepressants,thyroid hormone,chemotherapy or cortisone.

2)normal pregnancy(no eclampsia,no diabetes,no prolonged rupture of membranes or signs of infection)

3)singleton;term pregnancy (gestational age 37 weeks to 41 weeks 6days )in labour ward or cesarean section theatre.

4)The neonate should live within 100 km from the hospital (dibrugarh district) and parents should be willing to give consent and to come for follow up till 6 months of age.

5)Delivery should occur in week days between 8am to 8pm.

Exclusion Criteria

1)Rh incompatibility,congenital malformations or syndromes,

2)Parents not willing to participate and not willing to return for follow up

3)Term neonates admitted in NICU,delivery from 8pm to 8am,delivery on holidays.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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