Completed

In Vitro Myometrial Contractions in Laboring and Non-laboring Women: Oxytocin is Superior to Other Uterotonic Agents

What is being tested

Oxytocin

+ Ergonovine

+ Prostaglandin F2alpha

Drug

Who is being recruted

Urogenital Diseases+7

+ Female Urogenital Diseases and Pregnancy Complications

+ Hemorrhage

+7 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Interventional

Study Start: March 2009

See protocol details

Summary

Principal SponsorSamuel Lunenfeld Research Institute, Mount Sinai Hospital

Last updated: September 21, 2012

Sourced from a government-validated database.Claim as a partner

Study start date: March 1, 2009

Actual date on which the first participant was enrolled.

Postpartum hemorrhage (PPH) is a major cause of maternal mortality and morbidity. In 80% cases of PPH, the primary cause is failure of the uterus to contract after delivery of the baby, which then requires further treatment of the mother with uterotonic drugs (drugs used to contract uterus and thus prevent bleeding). Patients participating in this study will be asked to donate a very small sample of uterine tissue during Cesarean section, which will be tested in the laboratory for the ability to contract in response to the uterotonics oxytocin, ergonovine, prostaglandin F2alpha, and misoprostol. We will seek to better understand the effects of these drugs by comparing their contractile capability in isolated uterine tissue.

NCT01689311

Principal SponsorSamuel Lunenfeld Research Institute, Mount Sinai Hospital

Last updated: September 21, 2012

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

53 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Female

Biological sex of participants that are eligible to enroll.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsHemorrhageObstetric Labor ComplicationsPathologic ProcessesPregnancy ComplicationsPuerperal DisordersPathological Conditions, Signs and SymptomsUterine HemorrhagePostpartum Hemorrhage

Criteria

3 inclusion criteria required to participate

Cesarean section under spinal anesthesia

Gestational age 37-41 weeks

Patients requiring primary or first repeat Cesarean section

4 exclusion criteria prevent from participating

Patient who had previous myometrial surgery or more than one previous Cesarean section

Patients who require general anesthesia

Patients with multiple pregnancy (twins, etc.)

Patients with placental anomalies

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

All samples will undergo dose response treatment (increasing concentrations) of one of the four uterotonic drugs: oxytocin, ergonovine, prostaglandin F2alpha, or misoprostol.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Mount Sinai Hospital

Toronto, CanadaOpen Mount Sinai Hospital in Google Maps

CompletedOne Study Center