The trial was to determine the effect of administrating subcutaneous terbutaline prior to emergency caesarean delivery for suspected fetal distress
The trial was a double-blinded, placebo-controlled study using subcutaneous terbutaline for acute tocolysis prior to emergency caesarean delivery in suspected fetal distress. The intervention (subcutaneous terbutaline) was compared to placebo looking at the neonatal and maternal outcomes. The primary outcome was the proportion of babies with neonatal acidosis (based on umbilical artery blood sampling at delivery). Other outcome of interest were the mean cord pH and base excess, the Apgar score at 5 minutes after delivery, he proportion of babies requiring intubation and admission to the Neonatal Intensive Care Unit. The maternal outcomes of interest were the changes in mean arterial pressure (before and after the drug or placebo injection), the maternal heart rate changes, the estimated blood loss, and the hematocrit changes.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
100
Subcutaneous injection
Hospital Kemaman
Kuala Terengganu, Terengganu, Malaysia
Neonatal acidosis
Umbilical artery acidosis
Time frame: within 1 hour of delivery
Neonatal acid base status
Mean umbilical artery pH \& base excess
Time frame: within 1 hour of delivery
Neonatal Apgar score
Mean Apgar score at 5 minutes of life
Time frame: 5 minutes after delivery
Neonatal intensive care unit admission
Number of babies admitted to neonatal intensive care unit
Time frame: Within 24 hours of delivery
Maternal blood pressure
Mean maternal arterial pressure (before and after drug or placebo administration)
Time frame: Within 1 hours after drug administration
Maternal heart rate
Mean maternal heart rate changes (before and after drug or placebo administration)
Time frame: Within 1 hours after drug administration
Blood loss
Mean estimated blood loss
Time frame: Within 24 hours of delivery
Hematocrit change
Mean hematocrit changes before and after cesarean section
Time frame: Within 24 hours of delivery
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