Ignite Creation Date:
2025-12-24 @ 10:57 PM
Ignite Modification Date:
2025-12-30 @ 9:17 PM
Study NCT ID:
NCT05326269
Status:
COMPLETED
Last Update Posted:
2022-04-13
First Post:
2022-03-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Acute Tocolysis With Terbutaline for Suspected Fetal Distress
Sponsor:
Hospital Kemaman
Organization:
Study Overview
Official Title:
Acute Tocolysis With Terbutaline vs Placebo Prior to Emergency Caesarean Delivery for Suspected Intrauterine Fetal Compromise
Status:
COMPLETED
Status Verified Date:
2022-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The trial was to determine the effect of administrating subcutaneous terbutaline prior to emergency caesarean delivery for suspected fetal distress
Detailed Description:
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: