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| Name | Class |
|---|---|
| International Anesthesia Research Society (IARS) | OTHER |
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The purpose of this study in nulliparous women undergoing induction of labor is to determine whether initiation of neuraxial analgesia compared to systemic opioid analgesia early in labor (< 4 cm cervical dilation)affects the cesarean delivery rate.
Women in early labor frequently request pain medication. Obstetricians may prescribe narcotics (administered as an intravenous (IV) or intramuscular (IM) injection). However, IV or IM narcotics provide incomplete pain relief and have maternal and fetal/neonatal side effects, e.g., maternal drowsiness, respiratory depression, nausea, vomiting, and neonatal respiratory depression. Other obstetricians allow their patients to request early neuraxial (spinal or epidural) analgesia. The results of several studies comparing patients who received epidural versus IV/IM narcotic labor analgesia (not specifically in early labor)suggest that initiation of early neuraxial analgesia may be associated with higher Cesarean delivery rates. It has been hypothesized that epidural/spinal local anesthetics may induce pelvic musculature relaxation leading to failure of fetal descent and rotation. However, early pain may be a marker for other factors that increase the risk of Cesarean delivery, e.g., large or malpositioned baby, or dysfunctional labor. Whether or not early neuraxial analgesia (particularly if narcotic based, which would not cause pelvic muscle paralysis) compared to IV/IM narcotics, adversely affects the outcome of labor has not been studied in a randomized, prospective fashion. The purpose of this study is to compare Cesarean and forcep delivery rates, and quality of pain relief, in first-time mothers undergoing induction of labor who receive neuraxial versus IV/IM analgesia for early labor (cervical dilation < 4 cm).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| early analgesia:combined-spinal epidural | Active Comparator |
| |
| late analgesia (systemic) | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| combined spinal epidural analgesia | Procedure | Analgesia was initiated in the early group using a standard needle-through-needle technique with intrathecal fentanyl 25 mcg and an epidural test dose of lidocaine 15 mg/ml and epinephrine 5 mcg/ml in 3ml. At the second analgesia request, the cervix was examined. Epidural analgesia was initiated with a dilute bupivicaine/fentanyl solution if the cervix was less than 4 cm. If the cervix was 4 cm or more, epidural analgesia was initiated with bupivicaine 1.25 mg/ml. If no cervical exam was performed at the second request for analgesia, the cervix was assumed to be at least 4 cm dilated. Thereafter, analgesia was maintained in all participants in the early group with patient-controlled epidural analgesia. |
| Measure | Description | Time Frame |
|---|---|---|
| Delivered by Cesarean Section | The decision to proceed to operative delivery was made by the obstetric team for maternal or fetal indications. | Time form initiation of labor analgesia to delivery (up to 24 hours) |
| Measure | Description | Time Frame |
|---|---|---|
| Instrumented Vaginal Delivery | The decision to proceed to assisted/instrumental delivery was made by the obstetric team for maternal or fetal indications. | At time of decision for delivery |
| Duration of Labor |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cynthia A Wong, MD | Northwestern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern Memorial Hospital | Chicago | Illinois | 60611 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15716559 | Background | Wong CA, Scavone BM, Peaceman AM, McCarthy RJ, Sullivan JT, Diaz NT, Yaghmour E, Marcus RJ, Sherwani SS, Sproviero MT, Yilmaz M, Patel R, Robles C, Grouper S. The risk of cesarean delivery with neuraxial analgesia given early versus late in labor. N Engl J Med. 2005 Feb 17;352(7):655-65. doi: 10.1056/NEJMoa042573. |
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A total of 1,026 women consented to participate. 208 women were excluded because cervical dilation was 4 cm or more at the first analgesia request. Twelve participants were excluded after randomization because they did not receive the allocated intervention and outcome data were not available. The remaining 806 women were included in the analysis.
Between October 2001 and December 2006, women presenting at Prentice Women's Hospital for induction of labor and who desired neuraxial analgesia were eligible to participate. Patients were asked to participate by study personnel after admission to the Labor and Delivery Unit and gave written informed consent before request for analgesia.
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| ID | Title | Description |
|---|---|---|
| FG000 | Early Analgesia:Combined-spinal Epidural | Laboring women with induction of labor requesting analgesia at cervical dilation less than 4 cm randomized to receive spinal fentanyl 25 micrograms and epidural bupivacaine 6.25 mg/ml and fentanyl 1.96 micrograms/ml for labor analgesia. |
| FG001 | Systemic Analgesia | Laboring women with induction of labor requesting analgesia at cervical dilation less than 4 cm randomized to receive hydromorphone 1mg IM and 1mg IV until cervical dilation greater than 4 cm or third request for analgesia. Epidural |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Early Analgesia:Combined-spinal Epidural | Laboring women with induction of labor requesting analgesia at cervical dilation less than 4 cm randomized to receive spinal fentanyl 25 micrograms and epidural bupivacaine 6.25 mg/ml and fentanyl 1.96 micrograms/ml for labor analgesia. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Delivered by Cesarean Section | The decision to proceed to operative delivery was made by the obstetric team for maternal or fetal indications. | Analysis per protocol. 10 did not receive intervention in combined spinal epidural group and 2 in the systemic analgesia group | Posted | Number | participants | Time form initiation of labor analgesia to delivery (up to 24 hours) |
|
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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 | Early Analgesia:Combined-spinal Epidural | Laboring women with induction of labor requesting analgesia at cervical dilation less than 4 cm randomized to receive spinal fentanyl 25 micrograms and epidural bupivacaine 6.25 mg/ml and fentanyl 1.96 micrograms/ml for labor analgesia. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea and/or vomiting | Gastrointestinal disorders | Systematic Assessment | Patient self assessment of nausea and or vomiting following analgesia treatment. All subjects that vomited reported nausea prior to vomiting. |
The study was not powered to detect a small difference between groups in the cesarean delivery rate. It was not blinded. Different obstetric providers have different management styles, and different triggers for performing cesarean delivery.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Robert J. McCarthy | Department of Anesthesiology; Northwestern University Feinberg School of Medicine | 312-926-9015 | r-mccarthy@northwestern.edu |
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| 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 |
|---|---|
| D004091 | Hydromorphone |
| D009294 | Narcotics |
| ID | Term |
|---|---|
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
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|
|
| late analgesia (systemic) | Procedure | Analgesia was initiated in the late group with hydromorphone 1mg intramuscularly (IM) and 1 mg intravenously (IV). If the cervix was less than 4 cm at the second analgesia request, hydromorphone analgesia was repeated. Epidural analgesia was initiated with bupivicaine 1.25 mg/ml if the cervix was 4 cm or more. At the third analgesia request, epidural analgesia was initiated regardless of cervical dilation. Thereafter, epidural analgesia was maintained with patient controlled analgesia until delivery. |
|
|
Labor was induced by initiating an oxytocin infusion or by infusing extra-amniotic saline followed by oxytocin. All participants had continuous external electronic fetal heart rate (FHR) monitoring and tocodynamometry. Internal fetal scalp electrodes were placed when the external tracing was not interpretable, and intrauterine pressure catheters were used to measure the intensity of contractions when deemed necessary by the obstetricians. Artificial rupture of membranes was performed, and nurses titrated oxytocin infusions according to institutional protocol.
| Initiation of induction of labor to time of delivery |
| Indication for Cesarean Delivery | The decision to proceed to operative delivery was made by the obstetric team for maternal or fetal indications. | At time of decision for delivery |
| Analgesia Efficacy | Patients were asked to rate their average pain score using an 11-point verbal rating score (VRS)for pain (0 - 10: 0= no pain, 10= worst pain imaginable) between 1st and 2nd analgesia request. | At first and second analgesia requests |
| Nausea | Participants were asked to rate their nausea (as none, mild, moderate, or severe) and report the presence or absence of vomiting. | At second analgesia request |
| Neonatal Outcome (APGAR Score < 7 at 5 Minutes) | Infant's Apgar scores measured at 5 minutes of life and were assigned by nurses and pediatricians responsible for neonatal assessment. The Apgar score is determined by evaluating the newborn baby on five simple criteria on a scale from zero to two, then summing the five values. The categories are skin color, pulse, reflex to stimulation, muscle tome, and breathing. The test was done at one and five minutes after birth, and may be repeated later if the score is and remains low. Scores 3 and below are generally regarded as critically low, 4 to 6 fairly low, and 7 to 10 generally normal. | APGAR score at 5 minutes |
| Vomiting | Vomiting during labor analgesia | Vomiting at second analgesia request |
| Allocation prior to analgesia request |
|
| Parous patient |
|
| Systemic Analgesia |
Laboring women with induction of labor requesting analgesia at cervical dilation less than 4 cm randomized to receive hydromorphone 1mg IM and 1mg IV until cervical dilation greater than 4 cm or third request for analgesia. Epidural |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Laboring women with induction of labor requesting analgesia at cervical dilation less than 4 cm randomized to receive hydromorphone 1mg IM and 1mg IV until cervical dilation greater than 4 cm or third request for analgesia. Epidural |
|
|
|
| Secondary | Instrumented Vaginal Delivery | The decision to proceed to assisted/instrumental delivery was made by the obstetric team for maternal or fetal indications. | Per protocol - subjects that delivered vaginally | Posted | Number | participants | At time of decision for delivery |
|
|
|
|
| Secondary | Duration of Labor | Labor was induced by initiating an oxytocin infusion or by infusing extra-amniotic saline followed by oxytocin. All participants had continuous external electronic fetal heart rate (FHR) monitoring and tocodynamometry. Internal fetal scalp electrodes were placed when the external tracing was not interpretable, and intrauterine pressure catheters were used to measure the intensity of contractions when deemed necessary by the obstetricians. Artificial rupture of membranes was performed, and nurses titrated oxytocin infusions according to institutional protocol. | Per protocol | Posted | Median | Inter-Quartile Range | minutes | Initiation of induction of labor to time of delivery |
|
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|
|
| Secondary | Indication for Cesarean Delivery | The decision to proceed to operative delivery was made by the obstetric team for maternal or fetal indications. | Number of cesarean deliveries | Posted | Number | participants | At time of decision for delivery |
|
|
|
|
| Secondary | Analgesia Efficacy | Patients were asked to rate their average pain score using an 11-point verbal rating score (VRS)for pain (0 - 10: 0= no pain, 10= worst pain imaginable) between 1st and 2nd analgesia request. | Posted | Median | Inter-Quartile Range | Scores on a scale | At first and second analgesia requests |
|
|
|
|
| Secondary | Nausea | Participants were asked to rate their nausea (as none, mild, moderate, or severe) and report the presence or absence of vomiting. | Posted | Number | participants | At second analgesia request |
|
|
|
|
| Secondary | Neonatal Outcome (APGAR Score < 7 at 5 Minutes) | Infant's Apgar scores measured at 5 minutes of life and were assigned by nurses and pediatricians responsible for neonatal assessment. The Apgar score is determined by evaluating the newborn baby on five simple criteria on a scale from zero to two, then summing the five values. The categories are skin color, pulse, reflex to stimulation, muscle tome, and breathing. The test was done at one and five minutes after birth, and may be repeated later if the score is and remains low. Scores 3 and below are generally regarded as critically low, 4 to 6 fairly low, and 7 to 10 generally normal. | Posted | Number | participants | APGAR score at 5 minutes |
|
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| Secondary | Vomiting | Vomiting during labor analgesia | Posted | Number | participants | Vomiting at second analgesia request |
|
|
|
|
| 0 |
| 406 |
| 32 |
| 406 |
| EG001 | Systemic Analgesia | Laboring women with induction of labor requesting analgesia at cervical dilation less than 4 cm randomized to receive hydromorphone 1mg IM and 1mg IV until cervical dilation greater than 4 cm or third request for analgesia. Epidural | 0 | 400 | 134 | 400 |
|
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| D006571 |
| Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D002492 | Central Nervous System Depressants |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D000700 | Analgesics |
| D018689 | Sensory System Agents |
| D018373 | Peripheral Nervous System Agents |
| D002491 | Central Nervous System Agents |
| D045506 | Therapeutic Uses |
| Non-reassuring fetal status |
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| Other |
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| Moderate |
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| Severe |
|