Labor Pain, Pregnancy
Conditions
Keywords
Oxytocin, Labor, Obstetric, Non-reassuring fetal heart rate, Epidural
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).
Interventions
DRUGRoutine oxytocin
per regular oxytocin protocols
DRUGHalf-dose oxytocin
The dose of oxytocin currently being administered will be halved and not increased until after 60 minutes initiation of labor analgesia
Sponsors
Northwestern University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 60 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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
Routine oxytocin: per regular oxytocin protocols | 86 |
| 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.
Half-dose oxytocin: The dose of oxytocin currently being administered will be halved and not increased until after 60 minutes initiation of labor analgesia | 86 |
| Total | 172 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Combined spinal epidural completed without notifying study team | 1 | 0 |
| Overall Study | Emergency cesarean section required | 0 | 2 |
| Overall Study | Multiple parasthesias at time after combined spinal epidural catheter placement | 0 | 1 |
| Overall Study | No oxytoxin administered prior to combined spinal epidural catheter placement | 1 | 0 |
Baseline characteristics
| Characteristic | Group B | Total | Group A |
|---|---|---|---|
| Age, Continuous | 32.35 Years | 32.5 Years | 32.9 Years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 9 Participants | 12 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 77 Participants | 160 Participants | 83 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Fetus gestational age in weeks | 39.3 Weeks | 39.1 Weeks | 39 Weeks |
| Maternal Mean Arterial Pressure | 89.94 millimeters mercury | 91.07 millimeters mercury | 92.06 millimeters mercury |
| Maternal weight | 79.26 Kilograms | 79.7 Kilograms | 80.31 Kilograms |
| Oxytocin dose at start of epidural procedure | 8.38 milliunits/mL | 7.9 milliunits/mL | 7.39 milliunits/mL |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 14 Participants | 24 Participants | 10 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants | 16 Participants | 11 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 11 Participants | 17 Participants | 6 Participants |
| Race (NIH/OMB) White | 56 Participants | 114 Participants | 58 Participants |
| Sex: Female, Male Female | 86 Participants | 172 Participants | 86 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 86 | 0 / 86 |
| other Total, other adverse events | 0 / 86 | 0 / 86 |
| serious Total, serious adverse events | 0 / 86 | 0 / 86 |
Outcome results
Primary
Incidence of Non-reassuring Fetal Heart Rate Tracings.
Incidence of non-reassuring fetal heart rate tracings during the first 60 minutes after the placement of epidural analgesia
Time frame: Request for labor analgesia up to the first 60 minutes after the epidural placement
Population: Data was not collected as the OB/MD who was a certified fetal heart rate evaluator on the team (OB/MD) left Northwestern University. The fetal heart rate data can only be collected, scored and analyzed by a certified fetal heart rate evaluator and there are none available for this project.