Association Between Fluid Administration, Oxytocin Administration, and Fetal Heart Rate Changes
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|ClinicalTrials.gov Identifier: NCT02121184|
Recruitment Status : Recruiting
First Posted : April 23, 2014
Last Update Posted : January 6, 2021
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.
|Condition or disease||Intervention/treatment||Phase|
|Pregnancy Labor Pain||Drug: Routine oxytocin Drug: Half-dose oxytocin||Not Applicable|
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).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||380 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Clinical Trial Evaluating the Interaction of Rapid Hydration and the Rate of Oxytocin Labor Augmentation on Fetal Heart Rate Changes and Maternal Fetal Outcomes|
|Actual Study Start Date :||April 2014|
|Estimated Primary Completion Date :||April 2022|
|Estimated Study Completion Date :||April 2022|
Active Comparator: 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
Drug: Routine oxytocin
per regular oxytocin protocols
Other Name: Pitocin
Experimental: 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.
Drug: Half-dose oxytocin
The dose of oxytocin currently being administered will be halved and not increased until after 60 minutes initiation of labor analgesia
Other Name: Pitocin
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02121184
|Contact: Paul Fitzgeraldfirstname.lastname@example.org|
|United States, Illinois|
|Prentice Women's Hospital||Recruiting|
|Chicago, Illinois, United States, 60611|
|Contact: Robert J McCarthy, PharmD 312-926-9015 email@example.com|
|Principal Investigator:||Paloma Toledo, M.D.||Northwestern University|