Nitroglycerin Versus Terbutaline for Intrapartum Fetal Resuscitation

• Sponsor: Stanford University (Other)
• Overall Status: Completed
• CT.gov ID: NCT00185887
• Collaborator: (none)
• Enrollment: 110
• Location: 1
• Arms: 2
• Duration (Months): 48
• Patients Per Site Per Month: 2.3

Study Details

Study Description

Brief Summary

To compare nitroglycerin and terbutaline for intrapartum fetal heart rate resuscitation

Condition or Disease	Intervention/Treatment	Phase
Fetal Distress	Drug: Terbutaline	N/A

Study Design

• Study Type: Interventional
• 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: Oct 1, 2003
• Actual Primary Completion Date: Jul 1, 2006
• Actual Study Completion Date: Oct 1, 2007

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. resolution of abnormal fetal heart tracing [Administration of study medication to resolution of abnormal fetal heart tracing or operative delivery.]

Secondary Outcome Measures

1. cesarean section rate [Data analysis]

2. operative vaginal delivery rate [Data analysis]

3. neonatal outcomes [time of delivery to time of discharge]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria::

• nonreassuring fetal heart rate tracing Exclusion Criteria:- maternal cardiac disease, placental abruption, intrauterine growth restriction, prior cesarean section

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Stanford University School of Medicine	Stanford	California	United States	94305

Sponsors and Collaborators

• Stanford University

Investigators

• Principal Investigator: Yasser Yehia El-Sayed, Stanford University

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• American Journal of Obstetrics and Gynecology. 2007 Oct;197(4):414.el-6

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00185887
• Other Study ID Numbers: 79504
• First Posted: Sep 16, 2005
• Last Update Posted: Mar 8, 2011
• Last Verified: Mar 1, 2011

• Additional relevant MeSH terms: Fetal Distress; Terbutaline

Study Results

No Results Posted as of Mar 8, 2011