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

NCT00787176 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 251

Last updated 2022-01-13

Study results available
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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.

Conditions

  • Pregnancy
  • Labor Pain

Interventions

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.

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.

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.

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.

Sponsors & Collaborators

Principal Investigators

  • Paloma Toledo, MD · Northwestern University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-09-30
Primary Completion
2012-07-31
Completion
2012-07-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00787176 on ClinicalTrials.gov