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Study Summary
This trial is testing whether reducing the rate of an oxytocin infusion before starting combined spinal epidural analgesia will decrease the incidence of adverse fetal heart rate changes.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- I received oxytocin to help start or speed up my labor as per hospital guidelines.I am a healthy woman at or past 37 weeks of pregnancy.I cannot have spinal or epidural pain relief.My baby's heart rate was category 3 before starting epidural pain relief.You are pregnant with only one baby.I regularly use pain relief medication.I have received opioid pain relief during labor.The baby is not in the head-down position for birth.I am asking for spinal or epidural pain relief.
- Group 1: Standard Dose Oxytocin
- Group 2: Half Dose Oxytocin
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Is it possible for me to become a participant in this clinical trial?
"This clinical trial is taking in 730 patients with fetal heart rate and rhythm irregularities, between 18 to 55 weeks of gestation. To be considered for this study, participants must meet specific criteria: healthy women at the end of their pregnancy term; expecting only one baby; desiring neuraxial analgesia during labour; and willing to use oxytocin according to institutional protocols as part of induction or augmentation procedures."
Is the age-range for this trial including individuals over twenty years old?
"The prerequisites for this experiment necessitate that participants must be aged between 18 and 55. However, 11 trials are available for younger patients and 48 studies cater to those over 65 years old."
How many participants have been recruited to this experiment?
"Affirmative. According to details hosted on clinicaltrials.gov, this medical research is still recruiting participants with the initial post published February 20th 2019 and edited May 10th 2022. Specifically, 730 patients are required across 2 sites for the study's completion."
Could you inform me if this clinical trial is still accepting participants?
"Affirmative. According to information present on clinicaltrials.gov, this clinical trial is actively recruiting participants and has been since it was first posted in February of 2019. The study calls for 730 individuals from two sites and the data was last modified on May 10th 2022."
What other research endeavors have explored the effectiveness of reduced Oxytocin dosages?
"In 2011, Hadassah University Medical Organization instigated the first studies on half dose Oxytocin. Since then, 311 trials have concluded with 53 still in progress; many of which are hosted by Iowa City's medical centres."
What purpose does Half dose Oxytocin typically serve?
"Oxytocin, in lower doses, is a therapeutic option for the management of excessive bleeding and to enhance uterine contractions during labour. Additionally, it may be prescribed to reinforce labor or other medical conditions."
What have been the results of research into the security implications of administering a half-strength dose of oxytocin?
"Our team at Power rated Half-dose Oxytocin as a 3 on the safety scale due to it being in Phase 4 trials, which suggests that this intervention is approved."
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