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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00957593
First Posted: August 12, 2009
Last Update Posted: May 29, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Joanne Quinones, MD, Lehigh Valley Hospital
  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: None (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 Joanne Quinones, MD, Lehigh Valley Hospital:

Primary Outcome Measures:
  • Cesarean Delivery [ Time Frame: 24-72 hours from admission for induction ]
    Mode of delivery is the primary outcome


Secondary Outcome Measures:
  • Perinatal Outcomes [ Time Frame: 24-72 hours ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Submitted: July 31, 2009
First Posted: August 12, 2009
Results First Submitted: October 13, 2012
Results First Posted: May 29, 2013
Last Update Posted: May 29, 2013
Last Verified: May 2013

Keywords provided by Joanne Quinones, MD, 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