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

Sponsor

Northwestern University (Other)

Overall Status

Completed

CT.gov ID

NCT02121184

Collaborator

(none)

177

Enrollment

Location

Arms

89.7

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pregnancy Labor Pain	Drug: Routine oxytocin Drug: Half-dose oxytocin	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

177 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Apr 1, 2014

Actual Primary Completion Date :

Sep 21, 2021

Actual Study Completion Date :

Sep 21, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Group A 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 per regular oxytocin protocols Other Names: Pitocin
Experimental: Group B 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 The dose of oxytocin currently being administered will be halved and not increased until after 60 minutes initiation of labor analgesia Other Names: Pitocin

Arm

Intervention/Treatment

Active Comparator: Group A

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

per regular oxytocin protocols

Other Names:

Pitocin

Experimental: Group B

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

The dose of oxytocin currently being administered will be halved and not increased until after 60 minutes initiation of labor analgesia

Other Names:

Pitocin

Outcome Measures

Primary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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