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Nitroglycerin Versus Terbutaline for Intrapartum Fetal Resuscitation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00185887
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : March 8, 2011
Sponsor:
Information provided by:
Stanford University

Brief Summary:
To compare nitroglycerin and terbutaline for intrapartum fetal heart rate resuscitation

Condition or disease Intervention/treatment Phase
Fetal Distress Drug: Terbutaline Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Nitroglycerin Versus Terbutaline for Intrapartum Fetal Resuscitation
Study Start Date : October 2003
Actual Primary Completion Date : July 2006
Actual Study Completion Date : October 2007

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. resolution of abnormal fetal heart tracing [ Time Frame: Administration of study medication to resolution of abnormal fetal heart tracing or operative delivery. ]

Secondary Outcome Measures :
  1. cesarean section rate [ Time Frame: Data analysis ]
  2. operative vaginal delivery rate [ Time Frame: Data analysis ]
  3. neonatal outcomes [ Time Frame: time of delivery to time of discharge ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00185887


Locations
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United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
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Principal Investigator: Yasser Yehia El-Sayed Stanford University
Additional Information:
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Responsible Party: Yasser Yehia El-Sayed, Stanford University School of Medicine
ClinicalTrials.gov Identifier: NCT00185887    
Other Study ID Numbers: 79504
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: March 8, 2011
Last Verified: March 2011
Additional relevant MeSH terms:
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Fetal Distress
Signs and Symptoms
Terbutaline
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