Clinical trial NCT02121184: Association Between Fluid Administration, Oxytocin Administration, and Fetal Heart Rate Changes
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Pregnancy
Labor Pain
Keywords: Oxytocin
Labor, Obstetric
Non-reassuring fetal heart rate
Epidural
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2014-04-23
Enrollment: 172
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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: 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: 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).

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of Non-reassuring Fetal Heart Rate Tracings.
timeFrame: Request for labor analgesia up to the first 60 minutes after the epidural placement
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Prentice Women's Hospital
state: Illinois
Study officials:
affiliation: Northwestern University
name: Charles Hogue, M.D.
role: STUDY_CHAIR
References:
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citation: Kinsella SM, Pirlet M, Mills MS, Tuckey JP, Thomas TA. Randomized study of intravenous fluid preload before epidural analgesia during labour. Br J Anaesth. 2000 Aug;85(2):311-3. doi: 10.1093/bja/85.2.311.
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