Induction of Labor With Oxytocin: When Should Oxytocin be Held?

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Joanne Quinones, MD, Lehigh Valley Hospital
ClinicalTrials.gov Identifier:
NCT00957593
First received: July 31, 2009
Last updated: May 28, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention
Labor Induction
Cesarean Delivery
Drug: Oxytocin
Drug: Oxytocin discontinuation

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Induction of Labor With Oxytocin: When Should Oxytocin be Held?

Resource links provided by NLM:


Further study details as provided by Lehigh Valley Hospital:

Primary Outcome Measures:
  • Cesarean Delivery [ Time Frame: 24-72 hours from admission for induction ] [ Designated as safety issue: No ]
    Mode of delivery is the primary outcome


Secondary Outcome Measures:
  • Perinatal Outcomes [ Time Frame: 24-72 hours ] [ Designated as safety issue: No ]

Enrollment: 252
Study Start Date: February 2009
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Oxytocin
Continuation of oxytocin per protocol once the patient reaches active labor
Drug: Oxytocin
Continuation of oxytocin once in active labor
Active Comparator: Oxytocin discontinuation
Oxytocin will be stopped once the patient reaches active labor
Drug: Oxytocin discontinuation
Oxytocin will be stopped once in active labor

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Exclusions include women with multiple gestations, previous cesarean sections, and documented fetal anomalies.
  • Women with contraindications to labor or induction will also be excluded.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00957593

Locations
United States, Pennsylvania
Lehigh Valley Health Network
Allentown, Pennsylvania, United States, 18105
Sponsors and Collaborators
Lehigh Valley Hospital
Investigators
Principal Investigator: Joanne N Quinones, MD MSCE Lehigh Valley Health Network
  More Information

Publications:
Responsible Party: Joanne Quinones, MD, Attending Physician, Lehigh Valley Hospital
ClinicalTrials.gov Identifier: NCT00957593     History of Changes
Other Study ID Numbers: 2-20080907
Study First Received: July 31, 2009
Results First Received: October 13, 2012
Last Updated: May 28, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Lehigh Valley Hospital:
Induction of labor in term pregnancies
Term pregnancy
Cesarean delivery

Additional relevant MeSH terms:
Oxytocin
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on August 20, 2014