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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 October 01, 2014