In Vitro Myometrial Contractions in Laboring and Non-laboring Women

NCT01689311 | Completed

• 2 other identifiers: 12-0609-0053-E
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare the ability of an isolated sample of uterine muscle tissue (in a tissue bath) to contract in the presence of various drugs. The drugs studied--uterotonics--are typically used to contract the uterus when a pregnant patient continues to bleed after delivery. Amongst common uterotonic drugs, namely oxytocin, ergonovine, prostaglandin F2alpha, and misoprostol, the most effective one to use is unknown. The investigators will be testing isolated uterine muscle samples to increasing concentrations of these four drugs in three patient populations: non-laboring, laboring without exogenous oxytocin augmentation, and laboring with oxytocin augmentation. Contractile measures will be measured and compared between all groups. The investigators hypothesize that oxytocin alone will have a weaker uterotonic effect in oxytocin-augmented laboring patients, and all four drugs will induce different patterns of contractions.

Conditions

Postpartum Hemorrhage

Keywords

Uterine contraction; Dose response; Non-laboring; Laboring; Laboring with oxytocin augmentation; Oxytocin; Ergonovine; Prostaglandin F2alpha; Misoprostol

Outcome Measures

Primary Outcomes (1)

• Amplitude of contraction

  4-5 hours

Secondary Outcomes (3)

• Integrated area under response curve (AUC)

  4-5 hours

• Basal tone

  4-5 hours

• Frequency of contraction

  4-5 hours

Study Arms (1)

Treatment

EXPERIMENTAL

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

Drug: Oxytocin; Drug: Ergonovine; Drug: Prostaglandin F2alpha; Drug: Misoprostol

Interventions

Oxytocin DRUG

Oxytocin, 10-10mol/L to 10-5mol/L; solution made in double-distilled autoclaved water and then tested in physiological salt solution.

Also known as: Pitocin

Treatment

Ergonovine DRUG

Ergonovine, 10-10mol/L to 10-5mol/L; solution made in double-distilled autoclaved water and then tested in physiological salt solution.

Also known as: Ergot, Ergometrine

Treatment

Prostaglandin F2alpha DRUG

Prostaglandin F2alpha, 10-10mol/L to 10-5mol/L; solution made in double-distilled autoclaved water and then tested in physiological salt solution.

Treatment

Misoprostol DRUG

Misoprostol, 10-10mol/L to 10-5mol/L; solution made in double-distilled autoclaved water and then tested in physiological salt solution.

Also known as: Synthetic prostaglandin E1

Treatment

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Gestational age 37-41 weeks
• Patients requiring primary or first repeat Cesarean section
• Cesarean section under spinal anesthesia

You may not qualify if:

• Patients who require general anesthesia
• Patient who had previous myometrial surgery or more than one previous Cesarean section
• Patients with placental anomalies
• Patients with multiple pregnancy (twins, etc.)

Sponsors & Collaborators

• Samuel Lunenfeld Research Institute, Mount Sinai Hospital: lead
• University of Toronto: collaborator
• Canadian Anesthesiologists' Society: collaborator

Study Sites (1)

Mount Sinai Hospital

Toronto, Ontario, M5G 1X5, Canada

Location

Related Publications (1)

• Balki M, Erik-Soussi M, Kingdom J, Carvalho JC. Comparative efficacy of uterotonic agents: in vitro contractions in isolated myometrial strips of labouring and non-labouring women. Can J Anaesth. 2014 Sep;61(9):808-18. doi: 10.1007/s12630-014-0190-1. Epub 2014 Jun 7.

  PMID: 24906304 DERIVED

MeSH Terms

Conditions

Postpartum Hemorrhage

Interventions

Oxytocin; Ergonovine; Dinoprost; Misoprostol

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Ergolines; Ergot Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Prostaglandins F; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors; Prostaglandins E, Synthetic; Prostaglandins, Synthetic

Study Officials

• Mrinalini Balki, MD

  MOUNT SINAI HOSPITAL

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2012
• First Posted: September 21, 2012
• Study Start: March 1, 2009
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2012
• Last Updated: September 21, 2012

Record last verified: 2012-09

Locations

CA (1)