In Vitro Myometrial Contractions in Laboring and Non-laboring Women

Not Applicable

Completed

• Conditions: Postpartum Hemorrhage
• Interventions: Drug: Oxytocin; Drug: Ergonovine; Drug: Prostaglandin F2alpha; Drug: Misoprostol

• Registration Number: NCT01689311
• Lead Sponsor: Samuel Lunenfeld Research Institute, Mount Sinai Hospital

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.

Detailed Description

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.

Study Timeline

• Study Start: 2009-03
• Primary Completion: 2011-08
• Study Completion: 2012-08
• Status Verified: 2012-09
• Study First Submitted: 2012-09-17
• Study First Submitted QC: 2012-09-20
• Last Update Submitted: 2012-09-20
• Study First Posted: 2012-09-21
• Last Update Posted: 2012-09-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 53

Inclusion Criteria

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

Exclusion Criteria

• 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.)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment	Prostaglandin F2alpha	All samples will undergo dose response treatment (increasing concentrations) of one of the four uterotonic drugs: oxytocin, ergonovine, prostaglandin F2alpha, or misoprostol.
Treatment	Ergonovine	All samples will undergo dose response treatment (increasing concentrations) of one of the four uterotonic drugs: oxytocin, ergonovine, prostaglandin F2alpha, or misoprostol.
Treatment	Misoprostol	All samples will undergo dose response treatment (increasing concentrations) of one of the four uterotonic drugs: oxytocin, ergonovine, prostaglandin F2alpha, or misoprostol.
Treatment	Oxytocin	All samples will undergo dose response treatment (increasing concentrations) of one of the four uterotonic drugs: oxytocin, ergonovine, prostaglandin F2alpha, or misoprostol.

Primary Outcome Measures

Name	Time	Method
Amplitude of contraction	4-5 hours

Secondary Outcome Measures

Name	Time	Method
Integrated area under response curve (AUC)	4-5 hours
Basal tone	4-5 hours
Frequency of contraction	4-5 hours

Trial Locations

Locations (1)

Mount Sinai Hospital; 🇨🇦 Toronto, Ontario, Canada