NCT00957593

Brief Summary

The investigators propose to perform a prospective randomized control trial to compare the rate of cesarean delivery in women where Oxytocin (OT) is discontinued once active labor begins (5 cm dilation) when compared with women where OT is continued at a maintenance level per the usual protocol. One study group will follow an oxytocin protocol which is incremental until 5 cm dilation and then maintained at the same level throughout labor. The second arm will follow an oxytocin protocol also incremental, but then discontinued once the cervix is 5 cm. The primary outcome will be the rate of cesarean delivery between the groups. Secondary outcomes to be evaluated will include duration of the labor, fetal heart rate abnormalities, and frequency of uterine hyperstimulation, maternal and neonatal outcomes. As mentioned in the study proposal, the proposed experimental arm is currently not performed as part of the oxytocin guidelines at the investigators' institution. One study from Israel suggests no difference in pregnancy outcomes with the proposed use of oxytocin. Although some providers stop the oxytocin in active labor for their patients, this is not a commonly performed procedure at the investigators' institution. The investigators are not aware of other institutions employing the above practice.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
252

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2009

Typical duration 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

February 1, 2009

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 31, 2009

Completed
12 days until next milestone

First Posted

Study publicly available on registry

August 12, 2009

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
1.8 years until next milestone

Results Posted

Study results publicly available

May 29, 2013

Completed
Last Updated

April 23, 2019

Status Verified

April 1, 2019

Enrollment Period

2.5 years

First QC Date

July 31, 2009

Results QC Date

October 13, 2012

Last Update Submit

April 1, 2019

Conditions

Labor InductionCesarean Delivery

Keywords

Induction of labor in term pregnanciesTerm pregnancyCesarean delivery

Outcome Measures

Primary Outcomes (1)

  • Cesarean Delivery

    Mode of delivery is the primary outcome

    24-72 hours from admission for induction

Secondary Outcomes (1)

  • Perinatal Outcomes

    24-72 hours

Study Arms (2)

Oxytocin

ACTIVE COMPARATOR

Continuation of oxytocin per protocol once the patient reaches active labor

Drug: Oxytocin

Oxytocin discontinuation

ACTIVE COMPARATOR

Oxytocin will be stopped once the patient reaches active labor

Drug: Oxytocin discontinuation

Interventions

OxytocinDRUG

Continuation of oxytocin once in active labor

Oxytocin
Oxytocin discontinuationDRUG

Oxytocin will be stopped once in active labor

Oxytocin discontinuation

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Candidates for the study are pregnant women (with one fetus) scheduled for induction of labor with oxytocin at term gestation or greater, regardless of the indication for induction, bishop score (cervical dilation) or parity.

You may not qualify if:

  • Women with contraindications to labor or induction will also be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lehigh Valley Health Network

Allentown, Pennsylvania, 18105, United States

Location

Related Publications (1)

  • Diven LC, Rochon ML, Gogle J, Eid S, Smulian JC, Quinones JN. Oxytocin discontinuation during active labor in women who undergo labor induction. Am J Obstet Gynecol. 2012 Dec;207(6):471.e1-8. doi: 10.1016/j.ajog.2012.08.035. Epub 2012 Sep 7.

    PMID: 22989707RESULT

MeSH Terms

Interventions

Oxytocin

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

Title
Joanne N. Quinones MD MSCE
Organization
Lehigh Valley Health Netword
joanne_n.quinones@lvhn.org
6104021221

Study Officials

  • Joanne N Quinones, MD MSCE

    Lehigh Valley Health Network

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Attending Physician

Study Record Dates

First Submitted

July 31, 2009

First Posted

August 12, 2009

Study Start

February 1, 2009

Primary Completion

August 1, 2011

Study Completion

August 1, 2011

Last Updated

April 23, 2019

Results First Posted

May 29, 2013

Record last verified: 2019-04

Locations

US(1)