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

Not Applicable
Terminated
Conditions
Pregnancy
Labor Pain
Interventions
Drug: Group B Intravenous bolus bolus 1000 ml lactated ringers solution oxytocin decrease to 1/2 current rate
Drug: Group D 125 mL/hr lactated ringers oxytocin decreased to 1/2 current rate
Drug: Group C 125 mL/hr of lactated ringers
Drug: Group A Intravenous bolus of 1000 ml lactated ringers solution
Registration Number
NCT00787176
Lead Sponsor
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: 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.

Recruitment & Eligibility

Status
TERMINATED
Sex
Female
Target Recruitment
251
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Group BGroup B Intravenous bolus bolus 1000 ml lactated ringers solution oxytocin decrease to 1/2 current rateAn 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 DGroup D 125 mL/hr lactated ringers oxytocin decreased to 1/2 current rateThe 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 CGroup C 125 mL/hr of lactated ringersThe maintenance infusion of 125 mL/hr of Lactated Ringers will be given with no additional fluid bolus. Oxytocin management continued per protocol.
Group AGroup A Intravenous bolus of 1000 ml lactated ringers solutionAn intravenous bolus of 1000 mL Lactated Ringers initiated when the patient is positioned for epidural placement. Oxytocin management continued as per protocol.
Primary Outcome Measures
NameTimeMethod
Number of Participants With Non-reassuring Fetal Heart Rate Tracings During the First 30 Minutes After the Placement of Epidural AnalgesiaRequest 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

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (2)

Northwestern University

🇺🇸

Chicago, Illinois, United States

Prentice Women's Hospital

🇺🇸

Chicago, Illinois, United States

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