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Oxytocin Dosing for Prolonged Labor
Study Summary
This trial will compare outcomes of different infusion rates of oxytocin to induce or augment labor in nulliparous women.
Timeline
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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Who is running the clinical trial?
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- I am a woman aged between 18 and 50.I have never had surgery on my uterus.My pregnancy ended in loss or my baby was diagnosed with a severe condition.I cannot have a baby through natural childbirth.I cannot or do not want to give verbal consent.I have had cervical ripening treatments that did not involve devices.I need medication to help with labor.
- Group 1: High dose oxytocin
- Group 2: Low dose oxytocin
- 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.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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
What hazards do users of low-dose oxytocin face?
"There is substantial evidence for the safety of low dose oxytocin, as it has already been approved by regulators; hence, Power rated it a 3 on their risk-scale."
Are geriatric patients included in this trial?
"The cut-off age for this medical trial is outlined in the inclusion criteria; applicants must be aged 18 or more, but not exceed 50 years old."
Does this research endeavor still have room for participants?
"Contrary to what was initially anticipated, data hosted on clinicaltrials.gov reveals that this medical investigation is not accepting patients at the moment. The study first appeared online on April 1st 2023 and its latest revision occurred on March 20th 2023. Happily, two other trials are actively searching for participants as of now."
Is my participation in this research endeavor permissible?
"Applicants to this clinical trial must have endured an extended period of labor and be between 18-50 years old. A total of 170 patients are expected to enroll in the study."
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