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

Primary Purpose

Pregnancy, Labor Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Routine oxytocin
Half-dose oxytocin
Sponsored by
Northwestern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pregnancy focused on measuring Oxytocin, Labor, Obstetric, Non-reassuring fetal heart rate, Epidural

Eligibility Criteria

18 Years - 60 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Prentice Women's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Group A

Group B

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Incidence of non-reassuring fetal heart rate tracings during the first 60 minutes after the placement of epidural analgesia

Secondary Outcome Measures

Full Information

First Posted
April 16, 2014
Last Updated
February 11, 2022
Sponsor
Northwestern University
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1. Study Identification

Unique Protocol Identification Number
NCT02121184
Brief Title
Association Between Fluid Administration, Oxytocin Administration, and Fetal Heart Rate Changes
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
April 2014 (Actual)
Primary Completion Date
September 21, 2021 (Actual)
Study Completion Date
September 21, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pregnancy, Labor Pain
Keywords
Oxytocin, Labor, Obstetric, Non-reassuring fetal heart rate, Epidural

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
177 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Active Comparator
Arm Description
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
Arm Title
Group B
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Routine oxytocin
Other Intervention Name(s)
Pitocin
Intervention Description
per regular oxytocin protocols
Intervention Type
Drug
Intervention Name(s)
Half-dose oxytocin
Other Intervention Name(s)
Pitocin
Intervention Description
The dose of oxytocin currently being administered will be halved and not increased until after 60 minutes initiation of labor analgesia
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paloma Toledo, M.D.
Organizational Affiliation
Northwestern University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Prentice Women's Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
11950182
Citation
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Results Reference
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Citation
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Results Reference
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PubMed Identifier
7943823
Citation
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Results Reference
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PubMed Identifier
1732771
Citation
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Citation
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PubMed Identifier
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Citation
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Citation
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Association Between Fluid Administration, Oxytocin Administration, and Fetal Heart Rate Changes

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