In Vitro Evaluation of Spontaneous and Oxytocin-induced Contractility of Pregnant Human Myometrium During Exposure to Dexmedetomidine

Postpartum Hemorrhage Clinical Trial

Official title:

In Vitro Evaluation of Spontaneous and Oxytocin-induced Contractility of Pregnant Human Myometrium During Exposure to Dexmedetomidine

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05511415
• Other study ID #: 22-05
• Status: Recruiting
• Phase: N/A
• Start date: November 2, 2022
• Est. completion date: July 2024

Study information

• Verified date: February 2024
• Source: Samuel Lunenfeld Research Institute, Mount Sinai Hospital
• Contact: Mrinalini Balki, MD
• Phone: 416-586-4800
• Email: mrinalini.balki[@]uhn.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 28
• Est. completion date: July 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.).

Related Conditions & MeSH terms

• Hemorrhage
• Postpartum Hemorrhage

Intervention

Drug:
• Oxytocin
Oxytocin solution, 20nM concentration
• Dexmedetomidine
Dexmedetomidine (10-9M to 10-4M)

Locations

Country	Name	City	State
Canada	Mount Sinai Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Amplitude of contraction	The maximum extent of uterine muscle contraction, measured in grams (g). The analysis is undertaken by attaching myometrial strips between an isometric force transducer and the base of an organ bath chamber.	4 hours
Secondary	Frequency of contraction	The number of contractions in uterine muscle (myometrium) over 10 minutes, spontaneously and in response to an agonist. The analysis is undertaken by attaching myometrial strips between an isometric force transducer and the base of an organ bath chamber.	4 hours
Secondary	Integrated area under response curve (AUC)		4 hours