Hospital Kemaman
Kuala Terengganu, Terengganu, 24000, Malaysia
NCT Number: NCT05326269
The trial was to determine the effect of administrating subcutaneous terbutaline prior to emergency caesarean delivery for suspected fetal distress
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Female
Interventional
Not applicable
Kuala Terengganu, Terengganu, 24000, Malaysia
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Subcutaneous injection
Other names: beta mimetic
Time frame: within 1 hour of delivery
Umbilical artery acidosis
Time frame: within 1 hour of delivery
Mean umbilical artery pH & base excess
Time frame: 5 minutes after delivery
Mean Apgar score at 5 minutes of life
Time frame: Within 24 hours of delivery
Number of babies admitted to neonatal intensive care unit
Time frame: Within 1 hours after drug administration
Mean maternal arterial pressure (before and after drug or placebo administration)
Time frame: Within 1 hours after drug administration
Mean maternal heart rate changes (before and after drug or placebo administration)
Time frame: Within 24 hours of delivery
Mean estimated blood loss
Time frame: Within 24 hours of delivery
Mean hematocrit changes before and after cesarean section
Hospital Kemaman
Other
Acute Tocolysis With Terbutaline vs Placebo Prior to Emergency Caesarean Delivery for Suspected Intrauterine Fetal Compromise
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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