Nitroglycerin Versus Terbutaline for Intrapartum Fetal Resuscitation - Full Text View

Sponsor:	Stanford University
Information provided by:	Stanford University
ClinicalTrials.gov Identifier:	NCT00185887

Purpose

To compare nitroglycerin and terbutaline for intrapartum fetal heart rate resuscitation

Condition	Intervention
Fetal Distress	Drug: Terbutaline

Study Type:	Interventional
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
Official Title:	Nitroglycerin Versus Terbutaline for Intrapartum Fetal Resuscitation

Resource links provided by NLM:

Drug Information available for: Nitroglycerin Terbutaline Terbutaline sulfate

U.S. FDA Resources

Further study details as provided by Stanford University:

Primary Outcome Measures:

resolution of abnormal fetal heart tracing [ Time Frame: Administration of study medication to resolution of abnormal fetal heart tracing or operative delivery. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

cesarean section rate [ Time Frame: Data analysis ] [ Designated as safety issue: No ]
operative vaginal delivery rate [ Time Frame: Data analysis ] [ Designated as safety issue: No ]
neonatal outcomes [ Time Frame: time of delivery to time of discharge ] [ Designated as safety issue: No ]

Enrollment:	110
Study Start Date:	October 2003
Study Completion Date:	October 2007
Primary Completion Date:	July 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Terbutaline	Drug: Terbutaline Terbutaline 250 micrograms intravenously for intrapartum fetal resuscitation. Nitroglycerine 400 micrograms intravenously for intrapartum fetal resuscitation.
Active Comparator: Nitroglycerine	Drug: Terbutaline Terbutaline 250 micrograms intravenously for intrapartum fetal resuscitation. Nitroglycerine 400 micrograms intravenously for intrapartum fetal resuscitation.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria::

nonreassuring fetal heart rate tracing

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00185887

Locations

United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305

Sponsors and Collaborators

Stanford University

Investigators

Principal Investigator:

Yasser Yehia El-Sayed

Stanford University

More Information

Additional Information:

American Journal of Obstetrics and Gynecology. 2007 Oct;197(4):414.el-6 This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Yasser Yehia El-Sayed, Stanford University School of Medicine
ClinicalTrials.gov Identifier:	NCT00185887 History of Changes
Other Study ID Numbers:	79504
Study First Received:	September 12, 2005
Last Updated:	March 4, 2011
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Fetal Distress
Signs and Symptoms
Nitroglycerin
Terbutaline
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs

Anti-Asthmatic Agents
Respiratory System Agents
Sympathomimetics
Tocolytic Agents
Reproductive Control Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 12, 2012