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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Pregnancy, Labor Pain

Intervention / Treatment
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* 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


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group A<br>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<br>* An intravenous bolus of 1000 mL Lactated Ringers initiated when the patient was positioned for epidural placement. Oxytocin management continued as per protocol.<br>* Other names: A;|
| Experimental: Group B<br>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<br>* 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.<br>* Other names: B;|
| Active Comparator: Group C<br>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<br>* The maintenance infusion of 125 mL/hr of Lactated Ringers will be given with no additional fluid bolus. Oxytocin management continued per protocol.<br>* Other names: C;|
| Experimental: Group D<br>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<br>* 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.<br>* Other names: D;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Request for labor analgesia up to the first 30 minutes after the placement of epidural | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Oxytocin, Labor, Obstetric, Non-reassuring fetal heart rate, epidural