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Effect of Infant Placement on Iron Stores in Infancy: A Pilot Study

D

Davison, James, D.O.

Status

Unknown

Conditions

Anemia
Iron Deficiency

Treatments

Procedure: abdominal placement
Procedure: perineum maintained

Study type

Interventional

Identifiers

NCT00675337
wghjmd1

Details and patient eligibility

About

This is a pilot study designed to assess the safety of placing an infant on the mother's abdomen at the time of delivery, prior to clamping the umbilical cord and the effect of placing the infant on the mother's abdomen on the infant's iron stores. It is possible that placing the infant on the mother's abdomen (above the placenta) may lower the infant's iron stores during early infancy.

Enrollment

30 estimated patients

Sex

Female

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • healthy pregnant women
  • 37 - 42 weeks of gestation
  • vaginal delivery
  • prenatal care initiated prior to 20 weeks of gestation

Exclusion criteria

  • maternal diabetes
  • intrauterine growth restriction
  • hypertensive disorders of pregnancy
  • chronic hypertension requiring medical therapy
  • Apgar score less than 7 at 5 minutes
  • unusual bleeding prior to delivery
  • alloimmunization
  • maternal hemoglobinopathy
  • need for immediate infant resuscitation preventing adherence to protocol

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

30 participants in 2 patient groups

perineum
Active Comparator group
Description:
infants maintained at the level of the perineum until umbilical cord clamping
Treatment:
Procedure: perineum maintained
abdomen
Experimental group
Description:
infants placed on the maternal abdomen prior to cord clamping
Treatment:
Procedure: abdominal placement

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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