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

Sponsor
Northwestern University (Other)
Overall Status
Terminated
CT.gov ID
NCT00787176
Collaborator
(none)
251
Enrollment
2
Locations
4
Arms
58
Duration (Months)
125.5
Patients Per Site
2.2
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Group A Intravenous bolus of 1000 ml lactated ringers solution
  • Drug: Group B Intravenous bolus bolus 1000 ml lactated ringers solution oxytocin decrease to 1/2 current rate
  • Drug: Group C 125 mL/hr of lactated ringers
  • Drug: Group D 125 mL/hr lactated ringers oxytocin decreased to 1/2 current rate
 N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
251 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Prevention
Official Title:
The Association Between Fluid Administration, Oxytocin Administration, and Fetal Heart Rate Changes
Study Start Date :
Sep 1, 2007
Actual Primary Completion Date :
Jul 1, 2012
Actual Study Completion Date :
Jul 1, 2012

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Group A

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

Drug: Group A Intravenous bolus of 1000 ml lactated ringers solution
An intravenous bolus of 1000 mL Lactated Ringers initiated when the patient was positioned for epidural placement. Oxytocin management continued as per protocol.
Other Names:
  • A

    		•
    Experimental: Group B

    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.

    Drug: Group B Intravenous bolus bolus 1000 ml lactated ringers solution oxytocin decrease to 1/2 current rate
    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.
    Other Names:
  • B

    		•
    Active Comparator: Group C

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

    Drug: Group C 125 mL/hr of lactated ringers
    The maintenance infusion of 125 mL/hr of Lactated Ringers will be given with no additional fluid bolus. Oxytocin management continued per protocol.
    Other Names:
  • C

    		•
    Experimental: Group D

    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.

    Drug: Group D 125 mL/hr lactated ringers oxytocin decreased to 1/2 current rate
    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.
    Other Names:
  • D

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Number of Participants With Non-reassuring Fetal Heart Rate Tracings During the First 30 Minutes After the Placement of Epidural Analgesia [Request for labor analgesia up to the first 30 minutes after the placement of epidural]

      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

    Eligibility Criteria

    Criteria

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

    Locations

    Site City State Country Postal Code
    1 Northwestern University Chicago Illinois United States 60611
    2 Prentice Women's Hospital Chicago Illinois United States 60611

    Sponsors and Collaborators

    • Northwestern University

    Investigators

    • Principal Investigator: Paloma Toledo, MD, Northwestern University

    Study Documents (Full-Text)

    More Information

    Publications

    Responsible Party:
    Paloma Toledo, Associate Professor of Anesthesiology, Northwestern University
    ClinicalTrials.gov Identifier:
    NCT00787176
    Other Study ID Numbers:
    • 0524-034
    First Posted:
    Nov 7, 2008
    Last Update Posted:
    Jan 13, 2022
    Last Verified:
    Jan 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Paloma Toledo, Associate Professor of Anesthesiology, Northwestern University
    Oxytocin
    Labor, Obstetric
    Non-reassuring fetal heart rate
    epidural
    Additional relevant MeSH terms:
    Labor Pain
    Pharmaceutical Solutions
    Oxytocin

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title Group A Full Oxytocin 1000 ml LR Group B 1/2 Oxytocin 1000 ml LR Group C Full Oxytocin No LR Group D 1/2 Oxytocin no Additional LR
    Arm/Group Description An intravenous bolus of 1000 mL Lactated Ringers initiated when the patient is positioned for epidural placement. Oxytocin management continued as per protocol. 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. 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. Group B: 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. Group C: 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. 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 will be halved and not increased for 60 minutes until after placement.
    Period Title: Overall Study
    STARTED 69 62 60 60
    COMPLETED 62 59 54 55
    NOT COMPLETED 7 3 6 5

    Baseline Characteristics

    Arm/Group Title Group A Group B Group C Group D Total
    Arm/Group Description An intravenous bolus of 1000 mL Lactated Ringers initiated when the patient is positioned for epidural placement. Oxytocin management continued as per protocol. 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. 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. Group B: 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. Group C: 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. 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 will be halved and not increased for 60 minutes until after placement. Total of all reporting groups
    Overall Participants 69 62 60 60 251
    Age (Count of Participants)
    <=18 years
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Between 18 and 65 years
    69
    100%
    62
    100%
    60
    100%
    60
    100%
    251
    100%
    >=65 years
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Age (Years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [Years]
    31.14
    (4.97)
    30.50
    (5.27)
    31.15
    (4.34)
    30.42
    (5.88)
    30.8
    (5.12)
    Sex: Female, Male (Count of Participants)
    Female
    69
    100%
    62
    100%
    60
    100%
    60
    100%
    251
    100%
    Male
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Region of Enrollment (participants) [Number]
    United States
    69
    100%
    62
    100%
    60
    100%
    60
    100%
    251
    100%
    Region of Enrollment (participants) [Number]
    United States
    69
    100%
    62
    100%
    60
    100%
    60
    100%
    251
    100%
    Body Mass Index (kg/m∧ 2) ((kg/m∧ 2)) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [(kg/m∧ 2)]
    29.64
    (4.49)
    28.26
    (3.63)
    30.77
    (6.1)
    30.51
    (5.96)
    29.8
    (5.05)
    Estimated Gestational Age (weeks) (Weeks) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [Weeks]
    39.18
    (1.17)
    39.06
    (1.21)
    39.6
    (1.04)
    39.02
    (1.34)
    39.22
    (1.19)
    Baseline oxytocin (milliunit/minute) ((milliunit/minute)) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [(milliunit/minute)]
    6.54
    (4.64)
    6.65
    (4.04)
    6.15
    (5.16)
    5.88
    (4.26)
    6.3
    (4.5)
    Cervical Dilation (cm) (centimeters) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [centimeters]
    3.54
    (1.10)
    3.72
    (1.01)
    3.6
    (1.32)
    3.52
    (1.01)
    3.6
    (1.11)
    Number of times pregnant (participants) [Number]
    1 pregnancy
    36
    52.2%
    38
    61.3%
    33
    55%
    40
    66.7%
    147
    58.6%
    2 pregnancies
    20
    29%
    9
    14.5%
    14
    23.3%
    8
    13.3%
    51
    20.3%
    3 pregnancies
    5
    7.2%
    6
    9.7%
    6
    10%
    7
    11.7%
    24
    9.6%
    4 pregnancies
    5
    7.2%
    5
    8.1%
    2
    3.3%
    2
    3.3%
    14
    5.6%
    5 pregnancies
    1
    1.4%
    1
    1.6%
    2
    3.3%
    1
    1.7%
    5
    2%
    6 pregnancies
    2
    2.9%
    2
    3.2%
    1
    1.7%
    1
    1.7%
    6
    2.4%
    7 pregnancies
    0
    0%
    1
    1.6%
    1
    1.7%
    0
    0%
    2
    0.8%
    8 pregnancies
    0
    0%
    0
    0%
    1
    1.7%
    1
    1.7%
    2
    0.8%
    Number of live births (participants) [Number]
    0 live births
    49
    71%
    44
    71%
    42
    70%
    47
    78.3%
    182
    72.5%
    1 live birth
    14
    20.3%
    13
    21%
    12
    20%
    10
    16.7%
    49
    19.5%
    2 live births
    4
    5.8%
    2
    3.2%
    4
    6.7%
    1
    1.7%
    11
    4.4%
    3 live births
    2
    2.9%
    2
    3.2%
    1
    1.7%
    1
    1.7%
    6
    2.4%
    4 live births
    0
    0%
    1
    1.6%
    1
    1.7%
    0
    0%
    2
    0.8%
    5 live births
    0
    0%
    0
    0%
    0
    0%
    1
    1.7%
    1
    0.4%

    Outcome Measures

    1. Primary Outcome
    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

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Group A Group B Group C Group D
    Arm/Group Description An intravenous bolus of 1000 mL Lactated Ringers initiated when the patient is positioned for epidural placement. Oxytocin management continued as per protocol. 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. 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. Group B: 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. Group C: 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. 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 will be halved and not increased for 60 minutes until after placement.
    Measure Participants 62 59 54 55
    Favorable fetal heart rate tracings
    47
    68.1%
    54
    87.1%
    44
    73.3%
    47
    78.3%
    Non reassuring fetal heart rate tracings
    15
    21.7%
    5
    8.1%
    10
    16.7%
    8
    13.3%
    2. Post-Hoc Outcome
    Title Delivery Type
    Description Type of delivery (vaginal, forceps assisted, cesarean, emergency cesarean section)
    Time Frame Delivery

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Group A Group B Group C Group D Group Sum
    Arm/Group Description An intravenous bolus of 1000 mL Lactated Ringers initiated when the patient is positioned for epidural placement. Oxytocin management continued as per protocol. 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. 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. Group B: 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. Group C: 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. 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 will be halved and not increased for 60 minutes until after placement. Sum of the four groups
    Measure Participants 69 62 60 60 251
    Normal spontanous vaginal delivery
    50
    72.5%
    43
    69.4%
    44
    73.3%
    44
    73.3%
    181
    72.1%
    Forceps assisted vaginal delivery
    6
    8.7%
    8
    12.9%
    2
    3.3%
    6
    10%
    22
    8.8%
    Cesarean delivery
    13
    18.8%
    11
    17.7%
    14
    23.3%
    10
    16.7%
    48
    19.1%

    Adverse Events

    Time Frame To time of delivery of baby.
    Adverse Event Reporting Description
    Arm/Group Title Group A Group B Group C Group D
    Arm/Group Description An intravenous bolus of 1000 mL Lactated Ringers initiated when the patient is positioned for epidural placement. Oxytocin management continued as per protocol. 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. 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. Group B: 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. Group C: 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. 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 will be halved and not increased for 60 minutes until after placement.
    All Cause Mortality
    Group A Group B Group C Group D
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/69 (0%) 0/62 (0%) 0/60 (0%) 0/60 (0%)
    Serious Adverse Events
    Group A Group B Group C Group D
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/69 (0%) 0/62 (0%) 0/60 (0%) 0/60 (0%)
    Pregnancy, puerperium and perinatal conditions
    Cesarean Section for Fetal Distress 0/69 (0%) 0 0/62 (0%) 0 0/60 (0%) 0 0/60 (0%) 0
    Other (Not Including Serious) Adverse Events
    Group A Group B Group C Group D
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/69 (0%) 0/62 (0%) 0/60 (0%) 0/60 (0%)

    Limitations/Caveats

    Study recruitment was stopped before reaching the determined a priori sample size.

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title Paloma Toledo
    Organization Northwerstern University
    Phone 312-472-3585
    Email p-toledo@northwestern.edu
    Responsible Party:
    Paloma Toledo, Associate Professor of Anesthesiology, Northwestern University
    ClinicalTrials.gov Identifier:
    NCT00787176
    Other Study ID Numbers:
    • 0524-034
    First Posted:
    Nov 7, 2008
    Last Update Posted:
    Jan 13, 2022
    Last Verified:
    Jan 1, 2022