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NCT00185887 Clinical Trial

Nitroglycerin Versus Terbutaline for Intrapartum Fetal Resuscitation

Fetal Distress Clinical Trial

Official title:
Nitroglycerin Versus Terbutaline for Intrapartum Fetal Resuscitation

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00185887
Other study ID # 79504
Secondary ID
Status Completed
Phase N/A
First received September 12, 2005
Last updated March 4, 2011
Start date October 2003
Est. completion date October 2007

Study information
Verified date March 2011
Source Stanford University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

To compare nitroglycerin and terbutaline for intrapartum fetal heart rate resuscitation

Recruitment information / eligibility
Status Completed
Enrollment 110
Est. completion date October 2007
Est. primary completion date July 2006
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria::

- nonreassuring fetal heart rate tracing

Exclusion Criteria:- maternal cardiac disease, placental abruption, intrauterine growth restriction, prior cesarean section

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Terbutaline
Terbutaline 250 micrograms intravenously for intrapartum fetal resuscitation. Nitroglycerine 400 micrograms intravenously for intrapartum fetal resuscitation.

Locations
Country Name City State
United States Stanford University School of Medicine Stanford California

Sponsors (1)
Lead Sponsor Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary resolution of abnormal fetal heart tracing Administration of study medication to resolution of abnormal fetal heart tracing or operative delivery. Yes
Secondary cesarean section rate Data analysis No
Secondary operative vaginal delivery rate Data analysis No
Secondary neonatal outcomes time of delivery to time of discharge No
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