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Study concluded prematurely prior to meeting intended goal recruitment.
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Active Comparator | An intravenous bolus of 1000 mL Lactated Ringers initiated when the patient is positioned for epidural placement. Oxytocin management continued as per protocol. |
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| Group B | Experimental | 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. |
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| Group C | Active Comparator | The maintenance infusion of 125 mL/hr of Lactated Ringers will be given with no additional fluid bolus. Oxytocin management continued per protocol. |
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| Group D | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Group A Intravenous bolus of 1000 ml lactated ringers solution | Drug | An intravenous bolus of 1000 mL Lactated Ringers initiated when the patient was positioned for epidural placement. Oxytocin management continued as per protocol. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Request for labor analgesia up to the first 30 minutes after the placement of epidural |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paloma Toledo, MD | Northwestern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern University | Chicago | Illinois | 60611 | United States | ||
| Prentice Women's Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11950182 | Background | Mardirosoff C, Dumont L, Boulvain M, Tramer MR. Fetal bradycardia due to intrathecal opioids for labour analgesia: a systematic review. BJOG. 2002 Mar;109(3):274-81. doi: 10.1111/j.1471-0528.2002.01380.x. | |
| 7943823 | Background | Clarke VT, Smiley RM, Finster M. Uterine hyperactivity after intrathecal injection of fentanyl for analgesia during labor: a cause of fetal bradycardia? Anesthesiology. 1994 Oct;81(4):1083. doi: 10.1097/00000542-199410000-00041. No abstract available. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Group A Full Oxytocin 1000 ml LR | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 7, 2007 |
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| Group B Intravenous bolus bolus 1000 ml lactated ringers solution oxytocin decrease to 1/2 current rate | Drug | 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. |
|
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| Group C 125 mL/hr of lactated ringers | Drug | The maintenance infusion of 125 mL/hr of Lactated Ringers will be given with no additional fluid bolus. Oxytocin management continued per protocol. |
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| Group D 125 mL/hr lactated ringers oxytocin decreased to 1/2 current rate | Drug | 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. |
|
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| Chicago |
| Illinois |
| 60611 |
| United States |
| 1732771 | Background | Lopez-Zeno JA, Peaceman AM, Adashek JA, Socol ML. A controlled trial of a program for the active management of labor. N Engl J Med. 1992 Feb 13;326(7):450-4. doi: 10.1056/NEJM199202133260705. |
| FG001 |
| Group B 1/2 Oxytocin 1000 ml LR |
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. |
| FG002 | Group C Full Oxytocin No LR | 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. |
| FG003 | Group D 1/2 Oxytocin no Additional LR | 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. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | 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. |
| BG003 | 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. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Region of Enrollment | Enrolled at Northwestern Medicine, Chicago,IL USA | Number | participants |
| |||||||||||||||
| Body Mass Index (kg/m∧ 2) | Mean | Standard Deviation | (kg/m∧ 2) |
| |||||||||||||||
| Estimated Gestational Age (weeks) | Mean | Standard Deviation | Weeks |
| |||||||||||||||
| Baseline oxytocin (milliunit/minute) | Mean | Standard Deviation | (milliunit/minute) |
| |||||||||||||||
| Cervical Dilation (cm) | Mean | Standard Deviation | centimeters |
| |||||||||||||||
| Number of times pregnant | Number | participants |
| ||||||||||||||||
| Number of live births | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Number | participants | Request for labor analgesia up to the first 30 minutes after the placement of epidural |
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| Post-Hoc | Delivery Type | Type of delivery (vaginal, forceps assisted, cesarean, emergency cesarean section) | Posted | Number | participants | Delivery |
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To time of delivery of baby.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 0 | 69 | 0 | 69 | 0 | 69 |
| EG001 | 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. | 0 | 62 | 0 | 62 | 0 | 62 |
| EG002 | 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. | 0 | 60 | 0 | 60 | 0 | 60 |
| EG003 | 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. | 0 | 60 | 0 | 60 | 0 | 60 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cesarean Section for Fetal Distress | Pregnancy, puerperium and perinatal conditions | Fetal Distress | Systematic Assessment | Need for Cesarean delivery because of fetal distress or intolerance. |
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Study recruitment was stopped before reaching the determined a priori sample size.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Paloma Toledo | Northwerstern University | 312-472-3585 | p-toledo@northwestern.edu |
| Jun 7, 2021 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D048949 | Labor Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000077325 | Ringer's Lactate |
| C007792 | Fumigant 93 |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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| Between 18 and 65 years |
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| >=65 years |
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| Male |
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| 2 pregnancies |
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| 3 pregnancies |
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| 4 pregnancies |
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| 5 pregnancies |
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| 6 pregnancies |
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| 7 pregnancies |
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| 8 pregnancies |
|
| 1 live birth |
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| 2 live births |
|
| 3 live births |
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| 4 live births |
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| 5 live births |
|
| Non reassuring fetal heart rate tracings |
|
| OG003 | 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. |
| OG004 | Group Sum | Sum of the four groups |
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