Back to resultsNitroglycerin Versus Terbutaline for Intrapartum Fetal Resuscitation
Primary Purpose
Fetal Distress
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Terbutaline
Sponsored by
About this trial
This is an interventional treatment trial for Fetal Distress
Eligibility Criteria
Inclusion Criteria:: nonreassuring fetal heart rate tracing Exclusion Criteria:- maternal cardiac disease, placental abruption, intrauterine growth restriction, prior cesarean section
Sites / Locations
- Stanford University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Terbutaline
Nitroglycerine
Arm Description
Outcomes
Primary Outcome Measures
resolution of abnormal fetal heart tracing
Secondary Outcome Measures
cesarean section rate
operative vaginal delivery rate
neonatal outcomes
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00185887
Brief Title
Nitroglycerin Versus Terbutaline for Intrapartum Fetal Resuscitation
Official Title
Nitroglycerin Versus Terbutaline for Intrapartum Fetal Resuscitation
Study Type
Interventional
2. Study Status
Record Verification Date
March 2011
Overall Recruitment Status
Completed
Study Start Date
October 2003 (undefined)
Primary Completion Date
July 2006 (Actual)
Study Completion Date
October 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Stanford University
4. Oversight
5. Study Description
Brief Summary
To compare nitroglycerin and terbutaline for intrapartum fetal heart rate resuscitation
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fetal Distress
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
110 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Terbutaline
Arm Type
Active Comparator
Arm Title
Nitroglycerine
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Terbutaline
Intervention Description
Terbutaline 250 micrograms intravenously for intrapartum fetal resuscitation. Nitroglycerine 400 micrograms intravenously for intrapartum fetal resuscitation.
Primary Outcome Measure Information:
Title
resolution of abnormal fetal heart tracing
Time Frame
Administration of study medication to resolution of abnormal fetal heart tracing or operative delivery.
Secondary Outcome Measure Information:
Title
cesarean section rate
Time Frame
Data analysis
Title
operative vaginal delivery rate
Time Frame
Data analysis
Title
neonatal outcomes
Time Frame
time of delivery to time of discharge
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria::
nonreassuring fetal heart rate tracing Exclusion Criteria:- maternal cardiac disease, placental abruption, intrauterine growth restriction, prior cesarean section
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yasser Yehia El-Sayed
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University School of Medicine
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Nitroglycerin Versus Terbutaline for Intrapartum Fetal Resuscitation
We'll reach out to this number within 24 hrs