Nitroglycerin Versus Terbutaline for Intrapartum Fetal Re... | NCT00185887

Studies
Nitroglycerin Versus Terbutaline for Intrapartum Fetal Resuscitation

NCT00185887

Sponsor

Stanford University

Status

Completed

Last Update Posted

Mar 8, 2011Estimated

Enrollment

110Actual

Phase

Not Applicable

Conditions

Fetal Distress

Interventions

Terbutaline

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2003

Primary Completion Date

Jul 2006Actual

Completion Date

Oct 2007Actual

First Submitted Date

Sep 12, 2005

First Submission Date that Met QC Criteria

Sep 12, 2005

First Posted Date

Sep 16, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 4, 2011

Last Update Posted Date

Mar 8, 2011Estimated

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

110Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Terbutaline	Active Comparator		Drug: Terbutaline
Nitroglycerine	Active Comparator		Drug: Terbutaline

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Terbutaline	Drug	Terbutaline 250 micrograms intravenously for intrapartum fetal resuscitation. Nitroglycerine 400 micrograms intravenously for intrapartum fetal resuscitation.	Nitroglycerine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
resolution of abnormal fetal heart tracing		Administration of study medication to resolution of abnormal fetal heart tracing or operative delivery.

Secondary Outcomes

Measure	Description	Time Frame
cesarean section rate		Data analysis
operative vaginal delivery rate		Data analysis
neonatal outcomes

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria::

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Yasser Yehia El-Sayed	Stanford University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Stanford University School of Medicine		Stanford	California	94305	United States

Condition Browse Module

MeSH Terms

ID	Term
D005316	Fetal Distress

Ancestor Terms

ID	Term
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D013726	Terbutaline

Ancestor Terms

ID	Term
D004983	Ethanolamines
D000605	Amino Alcohols
D000438	Alcohols
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided