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The study was terminated due to low enrollment due to competing studies and the PI has now left Northwestern.
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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: 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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Routine Oxytocin | Active Comparator | 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 |
|
| Half-dose Oxytocin | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Routine oxytocin | Drug | per regular oxytocin protocols |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Request for labor analgesia up to the first 60 minutes after the epidural placement |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Charles Hogue, M.D. | Northwestern University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Prentice Women's Hospital | Chicago | Illinois | 60611 | United States |
| 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. | |
| 19104358 | Background | Abrao KC, Francisco RPV, Miyadahira S, Cicarelli DD, Zugaib M. Elevation of uterine basal tone and fetal heart rate abnormalities after labor analgesia: a randomized controlled trial. Obstet Gynecol. 2009 Jan;113(1):41-47. doi: 10.1097/AOG.0b013e31818f5eb6. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Routine Oxytocin | 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 |
| FG001 | Half- Dose Oxytocin | 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 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Group B |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | 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 | 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. | Posted | Request for labor analgesia up to the first 60 minutes after the epidural placement |
|
Adverse events were collected up to 7 days after study intervention.
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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 | 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment | Nausea |
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Ended trial early due to low enrollment. Could not obtain a certified assessments of fetal heart tracings.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Paul Fitzgerald | Northwestern University | 312 695 1064 | p-fitzgerald2@northwestern.edu |
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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 | Mar 16, 2020 | Jun 26, 2023 | Prot_SAP_000.pdf |
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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 |
|---|---|
| D010121 | Oxytocin |
| ID | Term |
|---|---|
| D010909 | Pituitary Hormones, Posterior |
| D010907 | Pituitary Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
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| Half-dose oxytocin | Drug | The dose of oxytocin currently being administered will be halved and not increased until after 60 minutes initiation of labor analgesia |
|
|
| 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. |
| 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. |
| 998176 | Background | Lindmark G, Nilsson BA. A comparative study of uterine activity in labour induced with prostaglandin F2alpha or oxytocin and in spontaneous labour. I. Pattern of the uterine contractions. Acta Obstet Gynecol Scand. 1976;55(5):453-60. doi: 10.3109/00016347609158529. |
| 1603479 | Background | Satin AJ, Leveno KJ, Sherman ML, Brewster DS, Cunningham FG. High- versus low-dose oxytocin for labor stimulation. Obstet Gynecol. 1992 Jul;80(1):111-6. |
| 8822656 | Background | Hourvitz A, Alcalay M, Korach J, Lusky A, Barkai G, Seidman DS. A prospective study of high- versus low-dose oxytocin for induction of labor. Acta Obstet Gynecol Scand. 1996 Aug;75(7):636-41. doi: 10.3109/00016349609054688. |
| 10472877 | Background | Merrill DC, Zlatnik FJ. Randomized, double-masked comparison of oxytocin dosage in induction and augmentation of labor. Obstet Gynecol. 1999 Sep;94(3):455-63. doi: 10.1016/s0029-7844(99)00338-5. |
| 10901564 | Background | Sadler LC, Davison T, McCowan LM. A randomised controlled trial and meta-analysis of active management of labour. BJOG. 2000 Jul;107(7):909-15. doi: 10.1111/j.1471-0528.2000.tb11091.x. |
| 10992845 | Background | Kinsella SM, Pirlet M, Mills MS, Tuckey JP, Thomas TA. Randomized study of intravenous fluid preload before epidural analgesia during labour. Br J Anaesth. 2000 Aug;85(2):311-3. doi: 10.1093/bja/85.2.311. |
| 8957980 | Background | Cheek TG, Samuels P, Miller F, Tobin M, Gutsche BB. Normal saline i.v. fluid load decreases uterine activity in active labour. Br J Anaesth. 1996 Nov;77(5):632-5. doi: 10.1093/bja/77.5.632. |
| 19546798 | Background | ACOG Practice Bulletin No. 106: Intrapartum fetal heart rate monitoring: nomenclature, interpretation, and general management principles. Obstet Gynecol. 2009 Jul;114(1):192-202. doi: 10.1097/AOG.0b013e3181aef106. No abstract available. |
| Emergency cesarean section required |
|
| Combined spinal epidural completed without notifying study team |
|
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 |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Fetus gestational age in weeks | Mean | Full Range | Weeks |
|
| Maternal weight | Mean | Full Range | Kilograms |
|
| Maternal Mean Arterial Pressure | Mean arterial pressure equals diastolic pressure + 1/3 (systolic pressure - diastolic pressure) | Mean | Full Range | millimeters mercury |
|
| Oxytocin dose at start of epidural procedure | Oxytocin dose milliunits/mL is administered via intravenous catheter. | Mean | Full Range | milliunits/mL |
|
| OG001 |
| Half-dose Oxytocin |
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 |
|
| 0 |
| 86 |
| 0 |
| 86 |
| 0 |
| 86 |
| EG001 | 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 | 0 | 86 | 0 | 86 | 0 | 86 |
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| D006730 |
| Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |