NCT00185887

Brief Summary

To compare nitroglycerin and terbutaline for intrapartum fetal heart rate resuscitation

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2003

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2003

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2006

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2007

Completed
Last Updated

March 8, 2011

Status Verified

March 1, 2011

Enrollment Period

2.8 years

First QC Date

September 12, 2005

Last Update Submit

March 4, 2011

Conditions

Fetal Distress

Outcome Measures

Primary Outcomes (1)

  • resolution of abnormal fetal heart tracing

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

Secondary Outcomes (3)

  • cesarean section rate

    Data analysis

  • operative vaginal delivery rate

    Data analysis

  • neonatal outcomes

    time of delivery to time of discharge

Study Arms (2)

Terbutaline

ACTIVE COMPARATOR
Drug: Terbutaline

Nitroglycerine

ACTIVE COMPARATOR
Drug: Terbutaline

Interventions

TerbutalineDRUG

Terbutaline 250 micrograms intravenously for intrapartum fetal resuscitation. Nitroglycerine 400 micrograms intravenously for intrapartum fetal resuscitation.

NitroglycerineTerbutaline

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

Related Links

MeSH Terms

Conditions

Fetal Distress

Interventions

Terbutaline

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

EthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAmines

Study Officials

  • Yasser Yehia El-Sayed

    Stanford University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 16, 2005

Study Start

October 1, 2003

Primary Completion

July 1, 2006

Study Completion

October 1, 2007

Last Updated

March 8, 2011

Record last verified: 2011-03

Locations

US(1)