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

Primary Purpose

Pregnancy, Labor Pain

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Group A Intravenous bolus of 1000 ml lactated ringers solution
Group B Intravenous bolus bolus 1000 ml lactated ringers solution oxytocin decrease to 1/2 current rate
Group C 125 mL/hr of lactated ringers
Group D 125 mL/hr lactated ringers oxytocin decreased to 1/2 current rate
Sponsored by
Northwestern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention 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 18-60
  • 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.

Sites / Locations

  • Northwestern University
  • Prentice Women's Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

Active Comparator

Experimental

Arm Label

Group A

Group B

Group C

Group D

Arm Description

An intravenous bolus of 1000 mL Lactated Ringers initiated when the patient is positioned for epidural placement. Oxytocin management continued as per protocol.

An intravenous bolus of 1000 mL Lactated Ringers. The dose of oxytocin being administered at time of epidural placement will be halved and not increased for 60 minutes until after placement.

The maintenance infusion of 125 mL/hr of Lactated Ringers will be given with no additional fluid bolus. Oxytocin management continued per protocol.

The maintenance infusion of 125 mL/hr of Lactated Ringers will be 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.

Outcomes

Primary Outcome Measures

Number of Participants With Non-reassuring Fetal Heart Rate Tracings During the First 30 Minutes After the Placement of Epidural Analgesia
The number of participants who experience non-reassuring fetal heart rate tracings obtained via electronic recording during the first 30 minutes after the placement of epidural analgesia

Secondary Outcome Measures

Full Information

First Posted
November 6, 2008
Last Updated
January 5, 2022
Sponsor
Northwestern University
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1. Study Identification

Unique Protocol Identification Number
NCT00787176
Brief Title
The Association Between Fluid Administration, Oxytocin Administration, and Fetal Heart Rate Changes
Official Title
The Association Between Fluid Administration, Oxytocin Administration, and Fetal Heart Rate Changes
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Terminated
Why Stopped
Study concluded prematurely prior to meeting intended goal recruitment.
Study Start Date
September 2007 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
July 2012 (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: 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.
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.

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
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
251 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Active Comparator
Arm Description
An intravenous bolus of 1000 mL Lactated Ringers initiated when the patient is positioned for epidural placement. Oxytocin management continued as per protocol.
Arm Title
Group B
Arm Type
Experimental
Arm Description
An intravenous bolus of 1000 mL Lactated Ringers. The dose of oxytocin being administered at time of epidural placement will be halved and not increased for 60 minutes until after placement.
Arm Title
Group C
Arm Type
Active Comparator
Arm Description
The maintenance infusion of 125 mL/hr of Lactated Ringers will be given with no additional fluid bolus. Oxytocin management continued per protocol.
Arm Title
Group D
Arm Type
Experimental
Arm Description
The maintenance infusion of 125 mL/hr of Lactated Ringers will be 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.
Intervention Type
Drug
Intervention Name(s)
Group A Intravenous bolus of 1000 ml lactated ringers solution
Other Intervention Name(s)
A
Intervention Description
An intravenous bolus of 1000 mL Lactated Ringers initiated when the patient was positioned for epidural placement. Oxytocin management continued as per protocol.
Intervention Type
Drug
Intervention Name(s)
Group B Intravenous bolus bolus 1000 ml lactated ringers solution oxytocin decrease to 1/2 current rate
Other Intervention Name(s)
B
Intervention Description
An intravenous bolus of 1000 mL Lactated Ringers. The dose of oxytocin being administered at time of epidural placement will be halved and not increased for 60 minutes until after placement.
Intervention Type
Drug
Intervention Name(s)
Group C 125 mL/hr of lactated ringers
Other Intervention Name(s)
C
Intervention Description
The maintenance infusion of 125 mL/hr of Lactated Ringers will be given with no additional fluid bolus. Oxytocin management continued per protocol.
Intervention Type
Drug
Intervention Name(s)
Group D 125 mL/hr lactated ringers oxytocin decreased to 1/2 current rate
Other Intervention Name(s)
D
Intervention Description
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 will be halved and not increased for 60 minutes until after placement.
Primary Outcome Measure Information:
Title
Number of Participants With Non-reassuring Fetal Heart Rate Tracings During the First 30 Minutes After the Placement of Epidural Analgesia
Description
The number of participants who experience non-reassuring fetal heart rate tracings obtained via electronic recording during the first 30 minutes after the placement of epidural analgesia
Time Frame
Request for labor analgesia up to the first 30 minutes after the placement of epidural

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 18-60 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paloma Toledo, MD
Organizational Affiliation
Northwestern University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
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
Mardirosoff C, Dumont L, Boulvain M, Tramer MR. Fetal bradycardia due to intrathecal opioids for labour analgesia: a systematic review. BJOG. 2002 Mar;109(3):274-81. doi: 10.1111/j.1471-0528.2002.01380.x.
Results Reference
background
PubMed Identifier
7943823
Citation
Clarke VT, Smiley RM, Finster M. Uterine hyperactivity after intrathecal injection of fentanyl for analgesia during labor: a cause of fetal bradycardia? Anesthesiology. 1994 Oct;81(4):1083. doi: 10.1097/00000542-199410000-00041. No abstract available.
Results Reference
background
PubMed Identifier
1732771
Citation
Lopez-Zeno JA, Peaceman AM, Adashek JA, Socol ML. A controlled trial of a program for the active management of labor. N Engl J Med. 1992 Feb 13;326(7):450-4. doi: 10.1056/NEJM199202133260705.
Results Reference
background

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

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