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

Not Applicable

Terminated

• Conditions: Pregnancy; Labor Pain
• Interventions: Drug: Routine oxytocin; Drug: Half-dose oxytocin

• Registration Number: NCT02121184
• 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: 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).

Study Timeline

• Study Start: 2014-04
• Study First Submitted: 2014-04-16
• Study First Submitted QC: 2014-04-19
• Study First Posted: 2014-04-23
• Primary Completion: 2021-09-21
• Study Completion: 2021-09-21
• Results First Submitted: 2023-01-22
• Status Verified: 2024-05
• Results First Submitted QC: 2024-05-28
• Last Update Submitted: 2024-05-28
• Results First Posted: 2024-05-29
• Last Update Posted: 2024-05-29

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 172

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Routine Oxytocin	Routine oxytocin	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
Half-dose Oxytocin	Half-dose oxytocin	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.

Primary Outcome Measures

Name	Time	Method
Incidence of Non-reassuring Fetal Heart Rate Tracings.	Request for labor analgesia up to the first 60 minutes after the epidural placement	Incidence of non-reassuring fetal heart rate tracings during the first 60 minutes after the placement of epidural analgesia

Trial Locations

Locations (1)

Prentice Women's Hospital; 🇺🇸 Chicago, Illinois, United States