- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02908126
Compare Efficacy of Oxytocin Administrations on Postpartum Uterine Contractility
November 20, 2019 updated by: Oxytone Bioscience BV
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
4
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Stockholm, Sweden
- Karolinska Institute, Danderyd hospital,Dept of Obstetrics and Gynecology
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 40 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Oxytocin intravenous
single dose of intravenous (IV) oxytocin
|
Oxytocin drug
|
Experimental: Oxytocin tablet
single dose of oxytocin tablet
|
Oxytocin drug
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Uterine contractility: area under the curve (AUC)
Time Frame: 3 hours
|
3 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 3, 2018
Primary Completion (Actual)
June 27, 2019
Study Completion (Actual)
June 27, 2019
Study Registration Dates
First Submitted
September 16, 2016
First Submitted That Met QC Criteria
September 16, 2016
First Posted (Estimate)
September 20, 2016
Study Record Updates
Last Update Posted (Actual)
November 22, 2019
Last Update Submitted That Met QC Criteria
November 20, 2019
Last Verified
November 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- OXB-002
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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