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: Patients who receive a 1000 mL fluid bolus and lower rates of oxytocin administration will have fewer non-reassuring fetal heart rate (FHR) changes.

Detailed Description
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Informed, written consent will be obtained. At the time of request for labor analgesia, group assignment will be determined by opening an opaque envelope. Patients will be randomized to one of four groups. All subjects will receive a maintenance infusion of 125 mL Lactated Ringers (LR) solution throughout the study. For patients in Groups A or B, an intravenous bolus of 1000 mL LR will be initiated when the patient is positioned for epidural placement. The bolus will be administered through a free-flowing wide open intravenous catheter until complete. Patients in Groups C and D will not receive any additional fluid bolus and will only receive the maintenance infusion of 125 mL LR during the study period. Blinding will be maintained by the Labor and Delivery nurse by covering up the LR bolus fluid bag. If the patient is randomized to groups B or D, the dose of oxytocin currently being administered will be halved and not increased for the duration of the study period (60 minutes after the initiation of CSE).

Official Title
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A Clinical Trial Evaluating the Interaction of Rapid Hydration and the Rate of Oxytocin Labor Augmentation on Fetal Heart Rate Changes and Maternal Fetal Outcomes

Conditions
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Pregnancy, Labor Pain

Intervention / Treatment
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* Drug: Routine oxytocin
* Drug: Half-dose oxytocin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 and over Healthy nulliparous or multiparous women Term (>36 week gestation) Singleton pregnancy Spontaneous labor or spontaneous rupture of membranes Receive oxytocin Request neuraxial analgesia Exclusion Criteria: Under 18 years old Presence of any systemic disease (ex: diabetes mellitus, hypertension, preeclampsia Use of chronic analgesic medications Prior administration of system 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group A<br>Lactated Ringers bolus of 1000 mL will be initiated when the patient is positioned for epidural placement. Oxytocin management will continue as per the routine oxytocin protocol | Drug: Routine oxytocin<br>* per regular oxytocin protocols<br>* Other names: Pitocin;|
| Experimental: Group B<br>Lactated Ringers bolus of 1000 mL will be initiated when the patient is positioned for epidural placement. A half-dose oxytocin will be initiated and not increased until 60 minutes after. | Drug: Half-dose oxytocin<br>* The dose of oxytocin currently being administered will be halved and not increased until after 60 minutes initiation of labor analgesia<br>* Other names: Pitocin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of non-reassuring fetal heart rate tracings during the first 60 minutes after the placement of epidural analgesia |  | Request for labor analgesia up to the first 60 minutes after the epidural placement | 

 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