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Completed

NCT Number: NCT01689311

In Vitro Myometrial Contractions in Laboring and Non-laboring Women

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.

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Key information

Conditions

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

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Mount Sinai Hospital

Toronto, Ontario, M5G 1X5, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.)

Treatment and study plan

Oxytocin

Drug

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

Other names: Pitocin

Ergonovine

Drug

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

Other names: Ergot, Ergometrine

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.

Misoprostol

Drug

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

Other names: Synthetic prostaglandin E1

Primary outcomes

  1. Amplitude of contraction

    Time frame: 4-5 hours

Secondary outcomes

  1. Integrated area under response curve (AUC)

    Time frame: 4-5 hours

  2. Basal tone

    Time frame: 4-5 hours

  3. Frequency of contraction

    Time frame: 4-5 hours

Sponsors and collaborators

Lead sponsor

Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Other

Collaborators

  • Canadian Anesthesiologists' Society
  • University of Toronto

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2011
Study completion
2012
First posted
Sep 21, 2012
Registry last updated
Sep 21, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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