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

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02121184
Recruitment Status : Recruiting
First Posted : April 23, 2014
Last Update Posted : January 6, 2021
Information provided by (Responsible Party):
Paloma Toledo, Northwestern University

Brief Summary:

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: Patients who receive a 1000 mL fluid bolus and lower rates of oxytocin administration will have fewer non-reassuring fetal heart rate (FHR) changes.

Condition or disease Intervention/treatment Phase
Pregnancy Labor Pain Drug: Routine oxytocin Drug: Half-dose oxytocin Not Applicable

Detailed Description:

Informed, written consent will be obtained. At the time of request for labor analgesia, group assignment will be determined by opening an opaque envelope. Patients will be randomized to one of four groups.

All subjects will receive a maintenance infusion of 125 mL Lactated Ringers (LR) solution throughout the study. For patients in Groups A or B, an intravenous bolus of 1000 mL LR will be initiated when the patient is positioned for epidural placement. The bolus will be administered through a free-flowing wide open intravenous catheter until complete.

Patients in Groups C and D will not receive any additional fluid bolus and will only receive the maintenance infusion of 125 mL LR during the study period. Blinding will be maintained by the Labor and Delivery nurse by covering up the LR bolus fluid bag.

If the patient is randomized to groups B or D, the dose of oxytocin currently being administered will be halved and not increased for the duration of the study period (60 minutes after the initiation of CSE).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 380 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Clinical Trial Evaluating the Interaction of Rapid Hydration and the Rate of Oxytocin Labor Augmentation on Fetal Heart Rate Changes and Maternal Fetal Outcomes
Actual Study Start Date : April 2014
Estimated Primary Completion Date : April 2022
Estimated Study Completion Date : April 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Oxytocin

Arm Intervention/treatment
Active Comparator: Group A
Lactated Ringers bolus of 1000 mL will be initiated when the patient is positioned for epidural placement. Oxytocin management will continue as per the routine oxytocin protocol
Drug: Routine oxytocin
per regular oxytocin protocols
Other Name: Pitocin

Experimental: Group B
Lactated Ringers bolus of 1000 mL will be initiated when the patient is positioned for epidural placement. A half-dose oxytocin will be initiated and not increased until 60 minutes after.
Drug: Half-dose oxytocin
The dose of oxytocin currently being administered will be halved and not increased until after 60 minutes initiation of labor analgesia
Other Name: Pitocin

Primary Outcome Measures :
  1. 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 epidural placement ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

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

Exclusion Criteria:

  • Under 18 years old
  • Presence of any systemic disease (ex: diabetes mellitus, hypertension, preeclampsia
  • Use of chronic analgesic medications
  • Prior administration of system opioid labor analgesia
  • Non-vertex presentation
  • Induction of Labor
  • Contraindication to neuraxial analgesia

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 identifier (NCT number): NCT02121184

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Contact: Paul Fitzgerald 312-695-1064

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United States, Illinois
Prentice Women's Hospital Recruiting
Chicago, Illinois, United States, 60611
Contact: Robert J McCarthy, PharmD    312-926-9015   
Sponsors and Collaborators
Northwestern University
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Principal Investigator: Paloma Toledo, M.D. Northwestern University

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Responsible Party: Paloma Toledo, Assistant Professor of Anesthesiology, Northwestern University Identifier: NCT02121184    
Other Study ID Numbers: STU00074673
First Posted: April 23, 2014    Key Record Dates
Last Update Posted: January 6, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Paloma Toledo, Northwestern University:
Labor, Obstetric
Non-reassuring fetal heart rate
Additional relevant MeSH terms:
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Labor Pain
Neurologic Manifestations
Reproductive Control Agents
Physiological Effects of Drugs