NCT00684606

Brief Summary

The purpose of the present study is to evaluate the possible benefit of concurrent IV Oxytocin infusion with trans cervical Foley catheter for pre-induction cervical ripening.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P25-P50 for not_applicable pregnancy

Timeline
Completed

Started May 2008

Geographic Reach
1 country

1 active site

Status
unknown

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

May 1, 2008

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

May 22, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 26, 2008

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
Last Updated

June 19, 2008

Status Verified

June 1, 2008

Enrollment Period

2 years

First QC Date

May 22, 2008

Last Update Submit

June 18, 2008

Conditions

PregnancyInduction of Labor

Keywords

Induction of LaborLow Bishop ScoreTranscervical Foley Catheter.IV Oxytocin

Outcome Measures

Primary Outcomes (1)

  • The period of time needed for ripening the uterine cervix by Transcervical Foley catheter with or without IV Oxytocin infusion.

    year

Study Arms (2)

1

EXPERIMENTAL

Transcervical Foley catheter with IV Oxytocin

Drug: Oxytocin IV

2

NO INTERVENTION

Transcervical Foley catheter only

Interventions

Oxytocin IVDRUG

5 miu/1000ml Glu/Saline

Also known as: Pitocin
1

Eligibility Criteria

Age15 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Term pregnancy
  • Medical indication for labor induction by transcervical Foley catheter

You may not qualify if:

  • Preterm pregnancy
  • Contraindication for induction of labor by transcervical Foley catheter or by IV Oxytocin:
  • Uterine scar
  • Multiple pregnancy
  • PROM
  • Grand-multiparity
  • Placenta previa or marginal placenta
  • Spontaneous uterine contractions (more than 3 in 10 minutes)
  • Vaginal bleeding
  • Nonreassuring fetal heart rate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sheba medical center

Ramat Gan, Israel

RECRUITING

MeSH Terms

Interventions

Oxytocin

Intervention Hierarchy (Ancestors)

Pituitary Hormones, PosteriorPituitary HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Orit Moran, M.D.

    Sheba Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Orit Moran, MD

CONTACT

972-3-5302777orit.moran@sheba.health.gov.il

Baruch Feldman, MD, PhD

CONTACT

972-3-5303934baruch.feldman@sheba.health.gov.il

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

May 22, 2008

First Posted

May 26, 2008

Study Start

May 1, 2008

Primary Completion

May 1, 2010

Study Completion

May 1, 2010

Last Updated

June 19, 2008

Record last verified: 2008-06

Locations

IL(1)