In Vitro Evaluation of Spontaneous and Oxytocin-induced Contractility of Pregnant Human Myometrium During Exposure to Dexmedetomidine
1 other identifier
interventional
50
1 country
1
Brief Summary
Postpartum hemorrhage (PPH) remains to be one of the leading causes of maternal morbidity and mortality. It has been noted that an increasing number of PPH is attributed to the increased incidence of uterine atony. Myometrial contraction is affected by the choice of anesthetic technique and medications during cesarean delivery (CD). It has been proven that exposure to oxytocin during labor results in a decrease in myometrial contractions. Dexmedetomidine is a drug which has been used in obstetric practice due to its desirable effects such as decreasing pain, reduced elevation in blood pressure and heart rate, sedation, and diminished anesthetic requirement. It has been used as an adjunct during spinal or epidural anesthesia during CD and even during general anesthesia for some obstetric surgeries. The use of dexmedetomidine has been continuously rising due to its favorable effects. Its use as an adjunct in general anesthesia for obstetrical surgeries has been shown to have promising advantages. During this pandemic, dexmedetomidine has been utilized largely as a sedative in critically ill and intubated patients. This does not exclude critically ill pregnant patients who may also need to deliver urgently. Thus, it is important to investigate its effect on uterine contractility on this particular group of patients. The investigators hypothesize that dexmedetomidine causes a dose-dependent increase in contractility of the pregnant human myometrium, both spontaneous and oxytocin-induced.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Nov 2022
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 19, 2022
CompletedFirst Posted
Study publicly available on registry
August 23, 2022
CompletedStudy Start
First participant enrolled
November 2, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 21, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
November 22, 2024
CompletedFebruary 26, 2025
January 1, 2025
2.1 years
August 19, 2022
February 24, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Motility index
Motility index (MI) is a calculated outcome, based on the formula: frequency/(10 x amplitude). Frequency and amplitude are secondary outcome measures as described below. The analysis is undertaken by attaching myometrial strips between an isometric force transducer and the base of an organ bath chamber.
4 hours
Secondary Outcomes (3)
Amplitude of contraction
4 hours
Frequency of contraction
4 hours
Integrated area under response curve (AUC)
4 hours
Study Arms (6)
Dexmedetomidine
ACTIVE COMPARATORThe myometrial samples are bathed in increasing concentrations of dexmedetomidine (from 10 -9M to 10 -4M).
Oxytocin
ACTIVE COMPARATORThe myometrial samples are bathed in oxytocin 20nM.
Dexmedetomidine + Oxytocin
ACTIVE COMPARATORThe myometrial samples are bathed in oxytocin at 20nM along with dexmedetomidine (10-9M to 10-4M).
Oxytocin pre-treatment followed by Dexmedetomidine
ACTIVE COMPARATORThe myometrial samples are pre-treated with oxytocin (10-5M) for 2 hours, and then in increasing concentrations of dexmedetomidine (from 10 -9M to 10 -4M).
Oxytocin pre-treatment followed by Oxytocin
ACTIVE COMPARATORThe myometrial samples are pre-treated with oxytocin (10-5M) for 2 hours, and then bathed in oxytocin at 20nM.
Oxytocin pre-treatment followed by Dexmedetomidine + Oxytocin
ACTIVE COMPARATORThe myometrial samples are pre-treated with oxytocin (10-5M) for 2 hours, and then bathed in oxytocin at 20nM along with dexmedetomidine (10-9M to 10-4M)
Interventions
Oxytocin solution, 20nM concentration
Dexmedetomidine (10-9M to 10-4M)
Eligibility Criteria
You may qualify if:
- Pregnant patients scheduled for elective CD under regional anesthesia at 37-41 weeks of gestational age will be included in this study.
- Only patients for primary CD or repeat CD (1x) will be included in this study since excessive uterine scarring from multiple CD may affect the contractility of myometrial sample.
You may not qualify if:
- patient refusal
- emergency CD
- general anesthesia
- placenta accreta spectrum disorder
- any condition predisposing the patient to uterine atony (e.g. polyhydramnios, multiple gestation)
- patients taking medications affecting myometrial contractions(labetalol, magnesium etc.).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Mount Sinai Hospital
Toronto, Ontario, M5G1X5, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mrinalini Balki, MD
MOUNT SINAI HOSPITAL
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 19, 2022
First Posted
August 23, 2022
Study Start
November 2, 2022
Primary Completion
November 21, 2024
Study Completion
November 22, 2024
Last Updated
February 26, 2025
Record last verified: 2025-01
Data Sharing
- IPD Sharing
- Will not share