NCT00315913

Brief Summary

The purpose of this study is to determine whether propranolol is better than oxytocin for the treatment of labor abnormalities. The endpoint is the rate of vaginal delivery experienced by women receiving prolonged oxytocin versus propranolol.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2004

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
withdrawn

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

January 1, 2004

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

April 17, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 19, 2006

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
Last Updated

February 27, 2019

Status Verified

February 1, 2019

Enrollment Period

4.2 years

First QC Date

April 17, 2006

Last Update Submit

February 26, 2019

Conditions

Dysfunctional Labor

Keywords

LaborDysfunctional LaborLabor ArrestPrimary Cesarean Section Prevention

Study Arms (2)

IV Propranolol

EXPERIMENTAL

IV dose propranolol

Drug: Propranolol

IV Placebo

PLACEBO COMPARATOR

IV Placebo of saline solution equal to propranolol in volume

Other: IV Placebo

Interventions

PropranololDRUG

IV Propranolol 1mg/min for a total of 2 minutes. Total dose 2mg

Also known as: Inderal
IV Propranolol
IV PlaceboOTHER

IV Saline Solution

Also known as: Normal Saline
IV Placebo

Eligibility Criteria

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

You may qualify if:

  • Must be term pregnancy (\> 37 weeks)
  • Vertex presentation
  • Active labor (4-5 centimeters dilated)

You may not qualify if:

  • Heart disease
  • Diabetes
  • Currently taking propranolol
  • Contraindications to labor or vaginal delivery
  • Multiple gestations
  • Preterm
  • Chorioamnionitis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Long Beach Memorial Medical Center

Long Beach, California, 90806, United States

Location

MeSH Terms

Conditions

Dystocia

Interventions

PropranololSaline Solution

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

PhenoxypropanolaminesPropanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsPropanolsAminesNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPolycyclic CompoundsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Leah R Battista, MD

    University of California, Irvine

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor and MFM Division Director

Study Record Dates

First Submitted

April 17, 2006

First Posted

April 19, 2006

Study Start

January 1, 2004

Primary Completion

March 1, 2008

Study Completion

March 1, 2008

Last Updated

February 27, 2019

Record last verified: 2019-02

Locations

US(1)