PROCEDURE
When delivery is imminent (expected within 10 minutes), the doctor or the nurse will open a sealed, numbered, opaque envelope containing the treatment allocation. The interventions will consist of delayed clamping of the umbilical cord (≥180 seconds after delivery) with or without maternal oxygenation. In both intervention arms, the researcher will instruct the nurse to hold the newborn infant at a level about 20 cm below the vulva for 30 seconds and then place the baby on the mother’s abdomen (20 cm was chosen as a practically obtainable level because of the facility to fold down the lower part of the delivery bed). Babies born by caesarean section will be placed in the mother’s lap before clamping in accordance with clinical routines. Oxytocin (10 IU) will be administered intravenously immediately after cord clamping. The time from complete delivery of the baby to the first clamp on the umbilical cord will be measured with a stopwatch by the nurse assistant. Patients will be randomly allocated to one of two groups; maternal oxygenation via oxygen mask or nasal cannula will be applied in group I while it will not be applied in group II (Open air Group).
As soon as the baby is delivered and the cord is clamped Umbilical blood samples will be immediately taken from neonates for assessment of Hemoglobin status and APGAR score will be calculated. All other aspects of obstetric care will be managed according to standard practice at the hospital. All staff in the delivery unit will be trained by the researcher in the study procedures before the study will start.
BLINDING
The study design precluded either the mother giving birth or the doctor performing the intervention being blinded. Physicians performing neonatal examinations, staff members responsible for collection of blood samples and background data, and laboratory staff performing analyses of blood samples will be blinded to each infant’s allocation group.
STATISTICAL ANALYSIS
Data will be collected, verified, revised, and then edited on PC. The data will be then analyzed statistically using SPSS statistical package version 20.