Nitroglycerin Versus Terbutaline for Intrapartum Fetal Resuscitation

This study has been completed.
Sponsor:
Information provided by:
Stanford University
ClinicalTrials.gov Identifier:
NCT00185887
First received: September 12, 2005
Last updated: March 4, 2011
Last verified: March 2011
  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:


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:
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 April 15, 2014