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The Association Between Fluid Administration, Oxytocin Administration, and Fetal Heart Rate Changes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Cynthia Wong, Northwestern University
ClinicalTrials.gov Identifier:
NCT00787176
First received: November 6, 2008
Last updated: July 23, 2012
Last verified: July 2012
History of Changes
  Purpose

Fetal heart rate patterns are an important parameter in the diagnosis of non-reassuring fetal status. Combined-spinal epidural analgesia is a method of initiating labor analgesia used by approximately 90% of the parturients at Prentice Women's Hospital. Optimizing the variables which could affect fetal heart rate patterns at the time of initiation of analgesia, such as fluid administration and oxytocin management, could help us provide better care for our patients and their fetuses.

Hypotheses: The combination of fluid administration and lower doses of oxytocin administration will have fewer adverse fetal heart rate changes in the first 60 minutes following initiation of labor analgesia.


Condition Intervention
Pregnancy
Labor Pain
 Procedure: Lactated Ringers bolus of 1000 ml
Procedure: No additional fluid
Procedure: Routine oxytocin
Procedure: Half-dose oxytocin

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: The Association Between Fluid Administration, Oxytocin Administration, and Fetal Heart Rate Changes

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • Incidence of non-reassuring fetal heart rate tracings during the first 60 minutes after the placement of epidural analgesia [ Time Frame: Request for labor analgesia up to the first 60 minutes after the placement of epidural ] [ Designated as safety issue: Yes ]

Enrollment: 252
Study Start Date: September 2007
Study Completion Date: July 2012
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Group A
An intravenous bolus of 1000 mL Lactated Ringers initiated when the patient was positioned for epidural placement. Oxytocin management continued as per protocol.
 Procedure: Lactated Ringers bolus of 1000 ml
Lactated Ringers bolus of 1000 ml initiated at patient positioning for epidural placement
Procedure: Routine oxytocin
per regular oxytocin protocols
Experimental: Group B
An intravenous bolus of 1000 mL Lactated Ringers. The dose of oxytocin being administered at time of epidural placement was halved and not increased for 60 minutes until after placement.
 Procedure: Lactated Ringers bolus of 1000 ml
Lactated Ringers bolus of 1000 ml initiated at patient positioning for epidural placement
Procedure: Half-dose oxytocin
The dose of oxytocin currently being administered will be halved and not increased until after 60 minutes after initiation of labor analgesia
Active Comparator: Group C
The maintenance infusion of 125 mL/hr of Lactated Ringers was given with no additional fluid bolus. Oxytocin management continued per protocol.
 Procedure: No additional fluid
Regular maintenance infusion of Lactated Ringers @ 125 ml/hr; no additional fluids
Procedure: Routine oxytocin
per regular oxytocin protocols
Experimental: Group D
The maintenance infusion of 125 mL/hr of Lactated Ringers was given with no additional fluid bolus. The dose of oxytocin being administered at time of epidural placement was halved and not increased for 60 minutes until after placement.
 Procedure: No additional fluid
Regular maintenance infusion of Lactated Ringers @ 125 ml/hr; no additional fluids
Procedure: Half-dose oxytocin
The dose of oxytocin currently being administered will be halved and not increased until after 60 minutes after initiation of labor analgesia

Detailed Description:

After obtaining informed, written consent, candidates were randomized to one of four groups at the time of request for labor analgesia. All subjects received a maintenance infusion of Lactated Ringers(LR). For candidates in Groups A or B, an intravenous bolus of 1000 mL of LR was initiated. Candidates in Groups C and D did not receive any additional fluid. If randomized to group A or C, the oxytocin management was continued as per the normal active management of labor protocal (AMOL). If randomized to groups B or D, the dose of oxytocin that was being administered was halved and not increased until 60 minutes after the initiation of epidural analgesia. Fetal heart rate monitoring and frequency of uterine contractions were recorded by external tocodynamometry.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age 18-60
  • Healthy nulliparous or multiparous women
  • Term (>36 week gestation)
  • Singleton pregnancy
  • Spontaneous labor or with spontaneous rupture of membranes
  • Receive oxytocin
  • Request neuraxial analgesia

Exclusion Criteria:

  • Under 18 years of age
  • Presence of any systemic disease (e.g., diabetes mellitus, hypertension, preeclampsia)
  • Use of chronic analgesic medications
  • Prior administration of systemic opioid labor analgesia
  • Non-vertex presentation
  • Induction of labor
  • Contraindication to neuraxial analgesia.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00787176

Locations
United States, Illinois
Prentice Women's Hospital
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
Investigators
Principal Investigator: Cynthia A Wong, M.D. Northwestern University
  More Information

Publications:

Responsible Party: Cynthia Wong, Professor of Anesthesiology, Northwestern University
ClinicalTrials.gov Identifier: NCT00787176     History of Changes
Other Study ID Numbers: 0524-034
Study First Received: November 6, 2008
Last Updated: July 23, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Northwestern University:
Oxytocin
Labor, Obstetric
Non-reassuring fetal heart rate
epidural

Additional relevant MeSH terms:
Labor Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Oxytocin
 Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013