Association Between Fluid Administration, Oxytocin Administration, and Fetal Heart Rate Changes (NCT02121184) | Clinical Trial Compass
TerminatedNot Applicable
Association Between Fluid Administration, Oxytocin Administration, and Fetal Heart Rate Changes
Stopped: The study was terminated due to low enrollment due to competing studies and the PI has now left Northwestern.
United States172 participantsStarted 2014-04
Plain-language 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: Patients who receive a 1000 mL fluid bolus and lower rates of oxytocin administration will have fewer non-reassuring fetal heart rate (FHR) changes.
Who can participate
Age range
18 Years – 60 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age 18 and over
* Healthy nulliparous or multiparous women
* Term (\>36 week gestation)
* Singleton pregnancy
* Spontaneous labor or spontaneous rupture of membranes
* Receive oxytocin
* Request neuraxial analgesia
Exclusion Criteria:
* Under 18 years old
* Presence of any systemic disease (ex: diabetes mellitus, hypertension, preeclampsia
* Use of chronic analgesic medications
* Prior administration of system opioid labor analgesia
* Non-vertex presentation
* Induction of Labor
* Contraindication to neuraxial analgesia
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of Non-reassuring Fetal Heart Rate Tracings.
Timeframe: Request for labor analgesia up to the first 60 minutes after the epidural placement