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WithdrawnNCT00315913Updated Feb 27, 2019

Trial of Oxytocin Alone Versus Oxytocin and Propranolol for the Treatment of Abnormal Labor

A Phase 2 interventional study of Propranolol and IV Placebo in Dysfunctional Labor, sponsored by University of California, Irvine. Withdrawn at 1 site in United States. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-02-27.

Sponsored by University of California, Irvine · Phase 2, Interventional, and Treatment

Why this study was withdrawn
Lack of feasibility
Phase
Phase 2
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study 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.

Read the detailed description

This trial was designed to test if propranolo can reduce the c section rate for dysfuctional labor. Due to stringent inclution and exclusion criteria and low enrollment the study was closed.

02

Conditions studied

  • Dysfunctional Labor

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Keywords

  • Labor
  • Dysfunctional Labor
  • Labor Arrest
  • Primary Cesarean Section Prevention
03

In context

Dystocia

55 studies on the registry are indexed under Dystocia; 12 are open to participants now.

Browse Dystocia studies →

Lead sponsor

University of California, Irvine is the lead sponsor of 476 studies on the registry; 98 are open to participants now.

Of its 41 completed or terminated interventional studies of FDA-regulated products, 30 (73%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Heart disease
  • Diabetes
  • Currently taking propranolol
  • to labor or vaginal delivery
  • Multiple gestations
  • Preterm
  • Chorioamnionitis
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    IV Propranolol

    IV dose propranolol

    Drug: Propranolol

  • Placebo comparator
    IV Placebo

    IV Placebo of saline solution equal to propranolol in volume

    Other: IV Placebo

Interventions

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

    Also known as: Inderal

  • OtherIV Placebo

    IV Saline Solution

    Also known as: Normal Saline

06

Study locations

1 site
  • Long Beach Memorial Medical Center
    Long Beach, California 90806, United States
07

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jan 2004, a primary completion of Mar 2008 and a completion of Mar 2008. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 17, 2006
First posted
Apr 19, 2006
Start
Jan 2004
Primary completionActual
Mar 2008
CompletionActual
Mar 2008
Last update
Feb 27, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 27, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00315913
Responsible party
Deborah A. Wing (Professor and MFM Division Director, University of California, Irvine) — Principal investigator
First posted
Apr 19, 2006
Start date
Jan 2004
Primary completion
Mar 2008
Completion
Mar 2008
Last update
Feb 27, 2019

Study contacts

Leah R Battista, MD
principal investigator · University of California, Irvine

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Propranolol

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