Clinical TrialID 8195

Impact of Prophylactic Ephedrine on Fetal Heart Tracing and Uterine Tetanic Contraction After CSE

NCT05873218

Labor

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Record Fields

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Clinical Trial Id
8195
Evidence Id
8195
Core Evidence Id
8195
Source Clinical Trial Id
8193
Herb2 Clinical Trial Id
HBCT008193
Nct Id
NCT05873218
Title
Impact of Prophylactic Ephedrine on Fetal Heart Tracing and Uterine Tetanic Contraction After CSE
Status
Recruiting
Phase
Phase 4
Study Result
No
Study Condition
Labor
Study Type
Interventional
Study Design
Allocation: RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Intervention
DRUG: Ephedrine|DRUG: Normal Saline Placebo
Intervention Allocation
Randomized
Intervention Model
Sequential
Intervention Mask
Quadruple
Intervention Purpose
Prevention
Gender
Female
Age
Adult
Enrollment
150
Outcome Measure
Incidence of category II fetal heart rate tracing, Incidence of category II fetal heart rate tracing up to 30 minutes after administration of intrathecal opiate, day 1, 30 minutes after administration of intrathecal opiate
Sponsor Collaborator
Icahn School of Medicine at Mount Sinai
Funded By
OTHER
Location
Icahn School of Medicine at Mount SInai, New York, New York, 10029, United States
Other Id
STUDY-22-01334
Start Date
2023-06-26
Primary Completion Date
2025-04
Completion Date
2025-04
First Posted
2023-05-24
Results First Posted
Last Update Posted
2024-05-08
Study Document
Study Url
https://clinicaltrials.gov/study/NCT05873218
Title Cn
Title En
Impact of Prophylactic Ephedrine on Fetal Heart Tracing and Uterine Tetanic Contraction After CSE
Bilingual Status
semi_complete