Association Between Fluid Administration, Oxytocin Administration, and Fetal Heart Rate Changes
| Status: | Recruiting |
|---|---|
| Conditions: | Women's Studies |
| Therapuetic Areas: | Reproductive |
| Healthy: | No |
| Age Range: | 18 - 60 |
| Updated: | 10/6/2017 |
| Start Date: | April 2014 |
| End Date: | April 2019 |
| Contact: | Robert J McCarthy, PharmD |
| Email: | r-mccarthy@northwestern.edu |
| Phone: | 312-926-9015 |
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
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.
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.
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).
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).
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
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