In Vitro Optimization of Oxytocin-induced Myometrial Contractility by Propranolol

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

57 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-08

Study Completion Date

2022-08-20

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The rates of cesarean deliveries (CD) and postpartum hemorrhage (PPH) are on the rise, with failed induction and augmentation of labor as major contributing factors. Oxytocin is commonly used for labor induction, as well as during the third stage of labor to minimize the risk of primary PPH. At delivery, it is imperative that the uterus responds effectively to parenteral oxytocin. Poor response to oxytocin following delivery is commonly due to prolonged labor with oxytocin augmentation that is known to "desensitize" the myometrium. Despite the option of several second line uterotonic agents, none of them are as effective as oxytocin in controlling PPH. Given that poor uterine muscle contraction is the root cause of both failed induction or augmentation (leading to a CD in labor) and uterine atony (leading to PPH), there is an urgent and clinically important need to investigate novel methods to enhance oxytocin-induced myometrial contractions.

Propranolol, a beta adrenergic receptor agonist, has the potential to improve myometrial contractions by virtue of its ability to inhibit catecholamine production. The investigators plan to investigate the effects of propranolol in both naive and desensitized myometrium, in order to better understand its potential role in improving labor induction and reducing the risk of PPH following oxytocin exposure during labor.

The investigators hypothesize that propranolol is likely to potentiate the action of oxytocin upon human myometrium, to ultimately help improve the success of labor induction/augmentation and treatment of PPH.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

The Effect of Coadministration of Oral Propranolol to Oxytocin on Induction of Labor

NCT02702674

Poor; Labor

UNKNOWN PHASE3

Investigating the Effect of Pulsatile Administration of Oxytocin on the Desensitization of Human Myometrium In-vitro

NCT02338089

Postpartum Hemorrhage

COMPLETED NA

Recovery of Oxytocin Responsiveness in Pregnant Human Myometrial Explants After Oxytocin-Induced Desensitization: an In-vitro Analysis of Oxytocin Receptor Expression and Signaling

NCT02762669

Postpartum Hemorrhage

TERMINATED NA

A Comparison Between the Effect of Oxytocin Only and Oxytocin Plus Propranolol on Induction of Labor in Term Pregnancy

NCT03533699

Induction of Labor Affected Fetus / Newborn

UNKNOWN NA

In-vitro Myometrial Contractility After Oxytocin Pre-exposure in Women With Advanced Maternal Age and Morbid Obesity

NCT01865669

Postpartum Hemorrhage

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Myometrial samples will be used to investigate the effect of propranolol on uterine contractions when exposed to high and low doses of oxytocin (to simulate PPH treatment and labor induction respectively).

The tissue will also be frozen at the end of the experiment, and Western blotting will be used to investigate the effect of propranolol on the expression patterns and cellular distribution of the oxytocin receptor and beta-adrenergic receptor and their signaling pathways in desensitized myometrium.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Postpartum Hemorrhage

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Low Dose Oxytocin

The myometrial samples are bathed in an oxytocin solution at increasing concentrations (from 10 -12M to 10 -9M)

Group Type ACTIVE_COMPARATOR

Oxytocin

Intervention Type DRUG

Oxytocin in solution, ranging from 10 -12M to 10 -5M

Propranolol

The myometrial samples are bathed in a propranol solution at 10 -6M

Group Type ACTIVE_COMPARATOR

Propranolol

Intervention Type DRUG

Propranolol in solution, 10-6M

Propranolol + low dose oxytocin

The myometrial samples are bathed in an oxytocin solution at increasing concentrations (from 10 -12M to 10 -9M) plus propranol (10 -6M)

Group Type ACTIVE_COMPARATOR

Oxytocin

Intervention Type DRUG

Oxytocin in solution, ranging from 10 -12M to 10 -5M

Propranolol

Intervention Type DRUG

Propranolol in solution, 10-6M

High Dose Oxytocin

The myometrial samples are bathed in an oxytocin solution (10 -5M), followed by increasing concentrations of oxytocin (from 10 -8M to 10 -5M)

Group Type ACTIVE_COMPARATOR

Oxytocin

Intervention Type DRUG

Oxytocin in solution, ranging from 10 -12M to 10 -5M

High Dose Oxytocin, Propranolol-pretreated

The myometrial samples are bathed in an oxytocin solution (10 -5M) plus propranolol (10 -6M), followed by increasing concentrations of oxytocin (from 10 -8M to 10 -5M)

Group Type ACTIVE_COMPARATOR

Oxytocin

Intervention Type DRUG

Oxytocin in solution, ranging from 10 -12M to 10 -5M

Propranolol

Intervention Type DRUG

Propranolol in solution, 10-6M

High dose oxytocin + propranolol

The myometrial samples are bathed in an oxytocin solution (10 -5M), followed by increasing concentrations of oxytocin (from 10 -8M to 10 -5M) plus propranolol (10 -6M)

Group Type ACTIVE_COMPARATOR

Oxytocin

Intervention Type DRUG

Oxytocin in solution, ranging from 10 -12M to 10 -5M

Propranolol

Intervention Type DRUG

Propranolol in solution, 10-6M

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Oxytocin

Oxytocin in solution, ranging from 10 -12M to 10 -5M

Intervention Type DRUG

Propranolol

Propranolol in solution, 10-6M

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

pitocin

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients who give written consent to participate in this study
* Patients with gestational age 37-41 weeks
* Non-laboring patients, not exposed to exogenous oxytocin
* Patients requiring primary Cesarean delivery or first repeat Cesarean delivery

Exclusion Criteria

* Patients who refuse to give written informed consent
* Patients who require general anesthesia
* Patients who had previous uterine surgery or more than one previous Cesarean delivery
* Patients with any condition predisposing to uterine atony and postpartum hemorrhage, such as abnormal placentation, multiple gestation, preeclampsia, macrosomia, polyhydramnios, uterine fibroids, bleeding diathesis, chorioamnionitis, or a previous history of postpartum bleeding
* Emergency Cesarean section in labor
* Patients on medications that could affect myometrial contractility, such as nifedipine, labetolol or magnesium sulfate

Minimum Eligible Age

16 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes