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: The combination of fluid administration and lower doses of oxytocin administration will have fewer adverse fetal heart rate changes in the first 60 minutes following initiation of labor analgesia.
Detailed description
After obtaining informed, written consent, candidates were randomized to one of four groups at the time of request for labor analgesia. All subjects received a maintenance infusion of Lactated Ringers(LR). For candidates in Groups A or B, an intravenous bolus of 1000 mL of LR was initiated. Candidates in Groups C and D did not receive any additional fluid. If randomized to group A or C, the oxytocin management was continued as per the normal active management of labor protocal (AMOL). If randomized to groups B or D, the dose of oxytocin that was being administered was halved and not increased until 60 minutes after the initiation of epidural analgesia. Fetal heart rate monitoring and frequency of uterine contractions were recorded by external tocodynamometry.
Interventions
DRUGGroup A Intravenous bolus of 1000 ml lactated ringers solution
An intravenous bolus of 1000 mL Lactated Ringers initiated when the patient was positioned for epidural placement. Oxytocin management continued as per protocol.
DRUGGroup B Intravenous bolus bolus 1000 ml lactated ringers solution oxytocin decrease to 1/2 current rate
An intravenous bolus of 1000 mL Lactated Ringers. The dose of oxytocin being administered at time of epidural placement will be halved and not increased for 60 minutes until after placement.
DRUGGroup C 125 mL/hr of lactated ringers
The maintenance infusion of 125 mL/hr of Lactated Ringers will be given with no additional fluid bolus. Oxytocin management continued per protocol.
DRUGGroup D 125 mL/hr lactated ringers oxytocin decreased to 1/2 current rate
The maintenance infusion of 125 mL/hr of Lactated Ringers was given with no additional fluid bolus. The dose of oxytocin being administered at time of epidural placement will be halved and not increased for 60 minutes until after placement.
Sponsors
Northwestern University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* Age 18-60 * Healthy nulliparous or multiparous women * Term (\>36 week gestation) * Singleton pregnancy * Spontaneous labor or with spontaneous rupture of membranes * Receive oxytocin * Request neuraxial analgesia
Exclusion criteria
* Under 18 years of age * Presence of any systemic disease (e.g., diabetes mellitus, hypertension, preeclampsia) * Use of chronic analgesic medications * Prior administration of systemic opioid labor analgesia * Non-vertex presentation * Induction of labor * Contraindication to neuraxial analgesia.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Non-reassuring Fetal Heart Rate Tracings During the First 30 Minutes After the Placement of Epidural Analgesia | Request for labor analgesia up to the first 30 minutes after the placement of epidural | The number of participants who experience non-reassuring fetal heart rate tracings obtained via electronic recording during the first 30 minutes after the placement of epidural analgesia |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Group A An intravenous bolus of 1000 mL Lactated Ringers initiated when the patient is positioned for epidural placement. Oxytocin management continued as per protocol.
Group A: An intravenous bolus of 1000 mL Lactated Ringers initiated when the patient was positioned for epidural placement. Oxytocin management continued as per protocol. | 69 |
| Group B An intravenous bolus of 1000 mL Lactated Ringers. The dose of oxytocin being administered at time of epidural placement will be halved and not increased for 60 minutes until after placement.
Group B: An intravenous bolus of 1000 mL Lactated Ringers. The dose of oxytocin being administered at time of epidural placement will be halved and not increased for 60 minutes until after placement. | 62 |
| Group C The maintenance infusion of 125 mL/hr of Lactated Ringers will be given with no additional fluid bolus. Oxytocin management continued per protocol.
Group C: The maintenance infusion of 125 mL/hr of Lactated Ringers will be given with no additional fluid bolus. Oxytocin management continued per protocol. | 60 |
| Group D The maintenance infusion of 125 mL/hr of Lactated Ringers will be given with no additional fluid bolus. The dose of oxytocin being administered at time of epidural placement was halved and not increased for 60 minutes until after placement.
Group D: The maintenance infusion of 125 mL/hr of Lactated Ringers was given with no additional fluid bolus. The dose of oxytocin being administered at time of epidural placement will be halved and not increased for 60 minutes until after placement. | 60 |
| Total | 251 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Low quality fetal heart rate tracing | 7 | 3 | 6 | 5 |
Baseline characteristics
| Characteristic | Group A | Group B | Group C | Group D | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 69 Participants | 62 Participants | 60 Participants | 60 Participants | 251 Participants |
| Age, Continuous | 31.14 Years STANDARD_DEVIATION 4.97 | 30.50 Years STANDARD_DEVIATION 5.27 | 31.15 Years STANDARD_DEVIATION 4.34 | 30.42 Years STANDARD_DEVIATION 5.88 | 30.8 Years STANDARD_DEVIATION 5.12 |
| Baseline oxytocin (milliunit/minute) | 6.54 (milliunit/minute) STANDARD_DEVIATION 4.64 | 6.65 (milliunit/minute) STANDARD_DEVIATION 4.04 | 6.15 (milliunit/minute) STANDARD_DEVIATION 5.16 | 5.88 (milliunit/minute) STANDARD_DEVIATION 4.26 | 6.3 (milliunit/minute) STANDARD_DEVIATION 4.5 |
| Body Mass Index (kg/m∧ 2) | 29.64 (kg/m∧ 2) STANDARD_DEVIATION 4.49 | 28.26 (kg/m∧ 2) STANDARD_DEVIATION 3.63 | 30.77 (kg/m∧ 2) STANDARD_DEVIATION 6.1 | 30.51 (kg/m∧ 2) STANDARD_DEVIATION 5.96 | 29.8 (kg/m∧ 2) STANDARD_DEVIATION 5.05 |
| Cervical Dilation (cm) | 3.54 centimeters STANDARD_DEVIATION 1.1 | 3.72 centimeters STANDARD_DEVIATION 1.01 | 3.6 centimeters STANDARD_DEVIATION 1.32 | 3.52 centimeters STANDARD_DEVIATION 1.01 | 3.6 centimeters STANDARD_DEVIATION 1.11 |
| Estimated Gestational Age (weeks) | 39.18 Weeks STANDARD_DEVIATION 1.17 | 39.06 Weeks STANDARD_DEVIATION 1.21 | 39.6 Weeks STANDARD_DEVIATION 1.04 | 39.02 Weeks STANDARD_DEVIATION 1.34 | 39.22 Weeks STANDARD_DEVIATION 1.19 |
| Number of live births 0 live births | 49 participants | 44 participants | 42 participants | 47 participants | 182 participants |
| Number of live births 1 live birth | 14 participants | 13 participants | 12 participants | 10 participants | 49 participants |
| Number of live births 2 live births | 4 participants | 2 participants | 4 participants | 1 participants | 11 participants |
| Number of live births 3 live births | 2 participants | 2 participants | 1 participants | 1 participants | 6 participants |
| Number of live births 4 live births | 0 participants | 1 participants | 1 participants | 0 participants | 2 participants |
| Number of live births 5 live births | 0 participants | 0 participants | 0 participants | 1 participants | 1 participants |
| Number of times pregnant 1 pregnancy | 36 participants | 38 participants | 33 participants | 40 participants | 147 participants |
| Number of times pregnant 2 pregnancies | 20 participants | 9 participants | 14 participants | 8 participants | 51 participants |
| Number of times pregnant 3 pregnancies | 5 participants | 6 participants | 6 participants | 7 participants | 24 participants |
| Number of times pregnant 4 pregnancies | 5 participants | 5 participants | 2 participants | 2 participants | 14 participants |
| Number of times pregnant 5 pregnancies | 1 participants | 1 participants | 2 participants | 1 participants | 5 participants |
| Number of times pregnant 6 pregnancies | 2 participants | 2 participants | 1 participants | 1 participants | 6 participants |
| Number of times pregnant 7 pregnancies | 0 participants | 1 participants | 1 participants | 0 participants | 2 participants |
| Number of times pregnant 8 pregnancies | 0 participants | 0 participants | 1 participants | 1 participants | 2 participants |
| Region of Enrollment United States | 69 participants | 62 participants | 60 participants | 60 participants | 251 participants |
| Sex: Female, Male Female | 69 Participants | 62 Participants | 60 Participants | 60 Participants | 251 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 69 | 0 / 62 | 0 / 60 | 0 / 60 |
| other Total, other adverse events | 0 / 69 | 0 / 62 | 0 / 60 | 0 / 60 |
| serious Total, serious adverse events | 0 / 69 | 0 / 62 | 0 / 60 | 0 / 60 |
Outcome results
Primary
Number of Participants With Non-reassuring Fetal Heart Rate Tracings During the First 30 Minutes After the Placement of Epidural Analgesia
The number of participants who experience non-reassuring fetal heart rate tracings obtained via electronic recording during the first 30 minutes after the placement of epidural analgesia
Time frame: Request for labor analgesia up to the first 30 minutes after the placement of epidural
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group A | Number of Participants With Non-reassuring Fetal Heart Rate Tracings During the First 30 Minutes After the Placement of Epidural Analgesia | Favorable fetal heart rate tracings | 47 participants |
| Group A | Number of Participants With Non-reassuring Fetal Heart Rate Tracings During the First 30 Minutes After the Placement of Epidural Analgesia | Non reassuring fetal heart rate tracings | 15 participants |
| Group B | Number of Participants With Non-reassuring Fetal Heart Rate Tracings During the First 30 Minutes After the Placement of Epidural Analgesia | Non reassuring fetal heart rate tracings | 5 participants |
| Group B | Number of Participants With Non-reassuring Fetal Heart Rate Tracings During the First 30 Minutes After the Placement of Epidural Analgesia | Favorable fetal heart rate tracings | 54 participants |
| Group C | Number of Participants With Non-reassuring Fetal Heart Rate Tracings During the First 30 Minutes After the Placement of Epidural Analgesia | Favorable fetal heart rate tracings | 44 participants |
| Group C | Number of Participants With Non-reassuring Fetal Heart Rate Tracings During the First 30 Minutes After the Placement of Epidural Analgesia | Non reassuring fetal heart rate tracings | 10 participants |
| Group D | Number of Participants With Non-reassuring Fetal Heart Rate Tracings During the First 30 Minutes After the Placement of Epidural Analgesia | Favorable fetal heart rate tracings | 47 participants |
| Group D | Number of Participants With Non-reassuring Fetal Heart Rate Tracings During the First 30 Minutes After the Placement of Epidural Analgesia | Non reassuring fetal heart rate tracings | 8 participants |
Post Hoc
Delivery Type
Type of delivery (vaginal, forceps assisted, cesarean, emergency cesarean section)
Time frame: Delivery
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group A | Delivery Type | Normal spontanous vaginal delivery | 50 participants |
| Group A | Delivery Type | Cesarean delivery | 13 participants |
| Group A | Delivery Type | Forceps assisted vaginal delivery | 6 participants |
| Group B | Delivery Type | Forceps assisted vaginal delivery | 8 participants |
| Group B | Delivery Type | Normal spontanous vaginal delivery | 43 participants |
| Group B | Delivery Type | Cesarean delivery | 11 participants |
| Group C | Delivery Type | Forceps assisted vaginal delivery | 2 participants |
| Group C | Delivery Type | Normal spontanous vaginal delivery | 44 participants |
| Group C | Delivery Type | Cesarean delivery | 14 participants |
| Group D | Delivery Type | Normal spontanous vaginal delivery | 44 participants |
| Group D | Delivery Type | Cesarean delivery | 10 participants |
| Group D | Delivery Type | Forceps assisted vaginal delivery | 6 participants |
| Group Sum | Delivery Type | Forceps assisted vaginal delivery | 22 participants |
| Group Sum | Delivery Type | Normal spontanous vaginal delivery | 181 participants |
| Group Sum | Delivery Type | Cesarean delivery | 48 participants |