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Vasodilator

Oxytocin desensitized - plus nitroglycerin for Postpartum Hemorrhage

N/A
Waitlist Available
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 8 hours
Awards & highlights
All Individual Drugs Already Approved
No Placebo-Only Group
Approved for 5 Other Conditions

Summary

Oxytocin causes myometrial contraction via the oxytocin receptor (OTR). Desensitization of the OTR after exposure to oxytocin has been demonstrated in previous studies. The resultant need for a higher oxytocin dose to cause adequate uterine contraction in vivo has also been demonstrated in laboring women having received oxytocin for labor augmentation. Achieving rapid uterine relaxation can be invaluable for maternal and fetal wellbeing in some acute obstetric emergency settings. Nitroglycerin has become a commonly used agent for achieving rapid uterine relaxation amongst obstetric anesthesiologists. Previous studies have concluded that oxytocin can be used to re-establish uterine tone following nitroglycerin mediated relaxation. However, no studies to date have looked at the effects of nitroglycerin mediated relaxation of uterine muscle that has undergone oxytocin receptor desensitization. Nor has the response to oxytocin re-exposure and return of contractility in desensitized myometrium (following nitroglycerin) been examined. The investigators hypothesize that nitroglycerin will reduce and inhibit uterine contractions in both oxytocin pre-treated myometrium, as well as untreated myometrium in a dose dependent fashion, but that myometrium that has undergone OTR desensitization will require less nitroglycerin for contractions to abate. The investigators also expect that the dose of oxytocin required to re-establish equivalent contractions will be higher in the myometrial samples which have undergone nitroglycerin mediated relaxation.

Eligible Conditions
  • Postpartum Hemorrhage

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 hours for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Motility Index
Secondary study objectives
Amplitude of contraction
Isometric Contraction

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.

Trial Design

4Treatment groups
Active Control
Group I: Control groupActive Control1 Intervention
No oxytocin desensitization (pretreatment), no nitroglycerin
Group II: Oxytocin desensitized - plus nitroglycerinActive Control2 Interventions
Pretreated with oxytocin followed by nitroglycerin exposure
Group III: Non oxytocin desensitized - plus nitroglycerinActive Control1 Intervention
No oxytocin pretreatment, followed by nitroglycerin exposure
Group IV: Oxytocin desensitized - no nitroglycerinActive Control1 Intervention
Pretreated with oxytocin, no nitroglycerin exposure

Find a Location

Who is running the clinical trial?

Samuel Lunenfeld Research Institute, Mount Sinai HospitalLead Sponsor
130 Previous Clinical Trials
11,540 Total Patients Enrolled
30 Trials studying Postpartum Hemorrhage
1,800 Patients Enrolled for Postpartum Hemorrhage
Mrinalini Balki, MDPrincipal InvestigatorMOUNT SINAI HOSPITAL
29 Previous Clinical Trials
2,060 Total Patients Enrolled
22 Trials studying Postpartum Hemorrhage
1,330 Patients Enrolled for Postpartum Hemorrhage
~2 spots leftby Oct 2025