Fetal Distress Clinical Trial
Official title:
Nitroglycerin Versus Terbutaline for Intrapartum Fetal Resuscitation
Verified date | March 2011 |
Source | Stanford University |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
To compare nitroglycerin and terbutaline for intrapartum fetal heart rate resuscitation
Status | Completed |
Enrollment | 110 |
Est. completion date | October 2007 |
Est. primary completion date | July 2006 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria:: - nonreassuring fetal heart rate tracing Exclusion Criteria:- maternal cardiac disease, placental abruption, intrauterine growth restriction, prior cesarean section |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Stanford University School of Medicine | Stanford | California |
Lead Sponsor | Collaborator |
---|---|
Stanford University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | resolution of abnormal fetal heart tracing | Administration of study medication to resolution of abnormal fetal heart tracing or operative delivery. | Yes | |
Secondary | cesarean section rate | Data analysis | No | |
Secondary | operative vaginal delivery rate | Data analysis | No | |
Secondary | neonatal outcomes | time of delivery to time of discharge | No |
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