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Hormone Therapy
Oxytocin for Oxytocin Responsiveness
N/A
Recruiting
Led By Mrinalini Balki, MD
Research Sponsored by Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 hours
Awards & highlights
Study Summary
This trialwill investigate the effects of oxytocin on uterine muscle contraction, and how increasing rest periods can help reduce the incidence of postpartum hemorrhage and complications due to oxytocin use.
Eligible Conditions
- Postpartum Hemorrhage
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 hours
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 hours
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Oxytocin receptor (OTR) protein expression and localization
Secondary outcome measures
Oxytocin receptor (OTR) phosphorylation patterns
Protein expression levels of PLC, MEK5 and ERK5
Trial Design
8Treatment groups
Active Control
Group I: Control (no oxytocin) + No recoveryActive Control1 Intervention
A control experiment will be undertaken in which the myometrial explants will be exposed to PSS for 2-hours without any oxytocin. No recovery time.
Group II: Continuous oxytocin + No recoveryActive Control1 Intervention
10-5M oxytocin for 2 hours. No recovery time.
Group III: Continuous oxytocin + 30 minute recoveryActive Control1 Intervention
10-5M oxytocin for 2 hours. After 2 hours, the solution will be drained from the organ baths, and any residual solution will be removed by washing three times with PSS. Following this, the strip will be exposed to PSS for 30 minutes.
Group IV: Continuous oxytocin + 60 minute recoveryActive Control1 Intervention
10-5M oxytocin for 2 hours. After 2 hours, the solution will be drained from the organ baths, and any residual solution will be removed by washing three times with PSS. Following this, the strip will be exposed to PSS for 60 minutes.
Group V: Control (no oxytocin) + No recovery + 10-7 oxytocinActive Control1 Intervention
A second control experiment will be undertaken in which the myometrial explants will be exposed to PSS for 2-hours without any oxytocin. After 2 hours, the solution will be drained from the organ baths, and replaced with fresh PSS. Following this, the strip will be exposed to 10-7 oxytocin for 10 minutes.
Group VI: Continuous oxytocin + No recovery + 10-7 oxytocinActive Control1 Intervention
10-5M oxytocin for 2 hours. After 2 hours, the solution will be drained from the organ baths, and any residual solution will be removed by washing three times with PSS. Following this, the strip will be exposed to 10-7 oxytocin for 10 minutes.
Group VII: Continuous oxytocin + 30 minute recovery + 10-7 oxytocinActive Control1 Intervention
10-5M oxytocin for 2 hours. After 2 hours, the solution will be drained from the organ baths, and any residual solution will be removed by washing three times with PSS. Following this, the strip will be exposed to PSS for 30 minutes. The strip will then be exposed to 10-7 oxytocin for 10 minutes.
Group VIII: Continuous oxytocin + 60 minute recovery + 10-7 oxytocinActive Control1 Intervention
10-5M oxytocin for 2 hours. After 2 hours, the solution will be drained from the organ baths, and any residual solution will be removed by washing three times with PSS. Following this, the strip will be exposed to PSS for 60 minutes. The strip will then be exposed to 10-7 oxytocin for 10 minutes.
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Who is running the clinical trial?
Samuel Lunenfeld Research Institute, Mount Sinai HospitalLead Sponsor
127 Previous Clinical Trials
11,221 Total Patients Enrolled
30 Trials studying Postpartum Hemorrhage
1,709 Patients Enrolled for Postpartum Hemorrhage
Mrinalini Balki, MDPrincipal InvestigatorMOUNT SINAI HOSPITAL
29 Previous Clinical Trials
1,963 Total Patients Enrolled
22 Trials studying Postpartum Hemorrhage
1,239 Patients Enrolled for Postpartum Hemorrhage
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You need to be put to sleep with medicine during the study.You have a higher risk of experiencing heavy bleeding after giving birth due to medical conditions such as abnormal placenta, multiple pregnancies, high blood pressure during pregnancy, large baby size, excess amniotic fluid, uterine tumors, bleeding disorders, infection in the uterus or a history of heavy bleeding after giving birth.
Timeline:
This trial has the following timeline:- 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
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What are the criteria for enrollment in this scientific exploration?
"This trial is looking for 16 individuals with postpartum hemorrhage who meet the age criteria of between 16 and 40."
Answered by AI
Are minors permissible participants in this research?
"This research study is specifically looking for individuals between 16 and 40 years old. There are 65 trials available to those younger than 16, while 320 studies can be found suitable for people aged over 65."
Answered by AI
What medical purpose is the combination of Continuous oxytocin and 60 minute recovery most typically intended for?
"Oxytocin + 60 minute recovery is a treatment that typically used to address hemorrhage, but can also assist with labour, uterine contraction and the reinforcement of labor."
Answered by AI
How many participants are currently contributing to this research?
"Confirmed. According to clinicaltrials.gov, this medical experiment has been open for recruitment since the 3rd of August 2016 and was last updated on October 24th 2022. They are searching for 16 patients from a single clinic site."
Answered by AI
Are there any vacancies available for prospective participants of this trial?
"Affirmative. Clinicaltrials.gov maintains records of this ongoing medical trial, which was posted on August 3rd 2016 and recently updated in October 24th 2022. This study is actively recruiting 16 individuals from one facility for participation."
Answered by AI
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