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Compare Efficacy of Oxytocin Administrations on Postpartum Uterine Contractility

Primary Purpose

Post Partum Haemorrhage

Status
Terminated
Phase
Phase 1
Locations
Sweden
Study Type
Interventional
Intervention
Oxytocin
Sponsored by
Oxytone Bioscience BV
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Post Partum Haemorrhage

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Healthy, term pregnant female with a gestational age of 37-42 weeks (singleton)
  • Undergoing a planned primary and uncomplicated caesarean section (CS) for their first born under regional anaesthesia
  • Aged between 18 and 40 years (both inclusive)
  • Ability to communicate well with the Investigator and to comply with the requirements of the entire study
  • Willing to give informed consent in writing.

Exclusion Criteria:

  • Being obese with BMI ≥35 before pregnancy
  • History of, or existing thromboembolic, cardiovascular or cerebrovascular disorder
  • History of cervical cancer
  • History of severe infection of the uterus
  • Previous surgery of the cervix or uterus or any other (previous) condition that could interfere with the measurement of uterine contractility
  • Any clinically significant abnormality following review of medical history, laboratory result and physical examination at screening as judged by the Investigator
  • Conditions or disorders that might affect the absorption, distribution, metabolism or excretion of any of the study medication
  • Contraindications for oxytocin use
  • Hypersensitivity to the active substances or to any of the excipients of the investigational product (test product or comparator drug)
  • Present use or use within 30 days before the start of the study medication of one or more of the following medications: antihypertensive drugs, anti-coagulant therapy, medication that could affect myometrial contractility, sex steroids, prostaglandins and its analogues, inhalation anaesthetics, vasoconstrictors/sympathomimetics and caudal anaesthetics, vasopressin-like drugs
  • Administration of any other investigational drug within 3 months before first dosing
  • Tobacco use (smoking or snuffing), currently or within the last 6 months before screening

Sites / Locations

  • Karolinska Institute, Danderyd hospital,Dept of Obstetrics and Gynecology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Oxytocin intravenous

Oxytocin tablet

Arm Description

single dose of intravenous (IV) oxytocin

single dose of oxytocin tablet

Outcomes

Primary Outcome Measures

Uterine contractility: area under the curve (AUC)

Secondary Outcome Measures

Full Information

First Posted
September 16, 2016
Last Updated
November 20, 2019
Sponsor
Oxytone Bioscience BV
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1. Study Identification

Unique Protocol Identification Number
NCT02908126
Brief Title
Compare Efficacy of Oxytocin Administrations on Postpartum Uterine Contractility
Official Title
Compare Efficacy of Oxytocin Administrations on Postpartum Uterine Contractility
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Terminated
Why Stopped
No approval CA (MPA) of protocol amendment
Study Start Date
April 3, 2018 (Actual)
Primary Completion Date
June 27, 2019 (Actual)
Study Completion Date
June 27, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Oxytone Bioscience BV

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
This is a Phase I open-label, parallel-group clinical study in healthy term pregnant females undergoing a caesarean section. Two administrations of oxytocin will be tested, after which uterine contractility will be assessed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Partum Haemorrhage

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Oxytocin intravenous
Arm Type
Experimental
Arm Description
single dose of intravenous (IV) oxytocin
Arm Title
Oxytocin tablet
Arm Type
Experimental
Arm Description
single dose of oxytocin tablet
Intervention Type
Drug
Intervention Name(s)
Oxytocin
Intervention Description
Oxytocin drug
Primary Outcome Measure Information:
Title
Uterine contractility: area under the curve (AUC)
Time Frame
3 hours

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy, term pregnant female with a gestational age of 37-42 weeks (singleton) Undergoing a planned primary and uncomplicated caesarean section (CS) for their first born under regional anaesthesia Aged between 18 and 40 years (both inclusive) Ability to communicate well with the Investigator and to comply with the requirements of the entire study Willing to give informed consent in writing. Exclusion Criteria: Being obese with BMI ≥35 before pregnancy History of, or existing thromboembolic, cardiovascular or cerebrovascular disorder History of cervical cancer History of severe infection of the uterus Previous surgery of the cervix or uterus or any other (previous) condition that could interfere with the measurement of uterine contractility Any clinically significant abnormality following review of medical history, laboratory result and physical examination at screening as judged by the Investigator Conditions or disorders that might affect the absorption, distribution, metabolism or excretion of any of the study medication Contraindications for oxytocin use Hypersensitivity to the active substances or to any of the excipients of the investigational product (test product or comparator drug) Present use or use within 30 days before the start of the study medication of one or more of the following medications: antihypertensive drugs, anti-coagulant therapy, medication that could affect myometrial contractility, sex steroids, prostaglandins and its analogues, inhalation anaesthetics, vasoconstrictors/sympathomimetics and caudal anaesthetics, vasopressin-like drugs Administration of any other investigational drug within 3 months before first dosing Tobacco use (smoking or snuffing), currently or within the last 6 months before screening
Facility Information:
Facility Name
Karolinska Institute, Danderyd hospital,Dept of Obstetrics and Gynecology
City
Stockholm
Country
Sweden

12. IPD Sharing Statement

Learn more about this trial

Compare Efficacy of Oxytocin Administrations on Postpartum Uterine Contractility

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