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

NCT ID: NCT05511415

Last Updated: 2025-02-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-02

Study Completion Date

2024-11-22

Brief Summary

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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.

Detailed Description

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Conditions

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Postpartum Hemorrhage

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Dexmedetomidine

The myometrial samples are bathed in increasing concentrations of dexmedetomidine (from 10 -9M to 10 -4M).

Group Type ACTIVE_COMPARATOR

Dexmedetomidine

Intervention Type DRUG

Dexmedetomidine (10-9M to 10-4M)

Oxytocin

The myometrial samples are bathed in oxytocin 20nM.

Group Type ACTIVE_COMPARATOR

Oxytocin

Intervention Type DRUG

Oxytocin solution, 20nM concentration

Dexmedetomidine + Oxytocin

The myometrial samples are bathed in oxytocin at 20nM along with dexmedetomidine (10-9M to 10-4M).

Group Type ACTIVE_COMPARATOR

Oxytocin

Intervention Type DRUG

Oxytocin solution, 20nM concentration

Dexmedetomidine

Intervention Type DRUG

Dexmedetomidine (10-9M to 10-4M)

Oxytocin pre-treatment followed by Dexmedetomidine

The 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).

Group Type ACTIVE_COMPARATOR

Oxytocin

Intervention Type DRUG

Oxytocin solution, 20nM concentration

Dexmedetomidine

Intervention Type DRUG

Dexmedetomidine (10-9M to 10-4M)

Oxytocin pre-treatment followed by Oxytocin

The myometrial samples are pre-treated with oxytocin (10-5M) for 2 hours, and then bathed in oxytocin at 20nM.

Group Type ACTIVE_COMPARATOR

Oxytocin

Intervention Type DRUG

Oxytocin solution, 20nM concentration

Oxytocin pre-treatment followed by Dexmedetomidine + Oxytocin

The 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)

Group Type ACTIVE_COMPARATOR

Oxytocin

Intervention Type DRUG

Oxytocin solution, 20nM concentration

Dexmedetomidine

Intervention Type DRUG

Dexmedetomidine (10-9M to 10-4M)

Interventions

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Oxytocin

Oxytocin solution, 20nM concentration

Intervention Type DRUG

Dexmedetomidine

Dexmedetomidine (10-9M to 10-4M)

Intervention Type DRUG

Other Intervention Names

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pitocin

Eligibility Criteria

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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.).
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Samuel Lunenfeld Research Institute, Mount Sinai Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mrinalini Balki, MD

Role: PRINCIPAL_INVESTIGATOR

MOUNT SINAI HOSPITAL

Locations

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Mount Sinai Hospital

Toronto, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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22-05

Identifier Type: -

Identifier Source: org_study_id

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