Post Partum HaemorrhagePhase 1NCT02908126
Compare Efficacy of Oxytocin Administrations on Postpartum Uterine Contractility
A Phase 1 study testing Oxytocin in people with Post Partum Haemorrhage, run by Oxytone Bioscience BV at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Post Partum Haemorrhage
- What is being tested?
- Oxytocin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteSweden
- Study dates
- 3 Apr 2018to 27 Jun 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Karolinska Institute, Danderyd hospital,Dept of Obstetrics and Gynecology
Stockholm
About this study
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.
- Conditions
- Post Partum Haemorrhage
- Being tested
- Oxytocin
- Medical subject headings
- Postpartum Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxytocinDrug
Oxytocin drug
| Study group | Role | What they receive |
|---|---|---|
| Oxytocin intravenous | Experimental | single dose of intravenous (IV) oxytocin Receives: Drug: Oxytocin |
| Oxytocin tablet | Experimental | single dose of oxytocin tablet Receives: Drug: Oxytocin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Uterine contractility: area under the curve (AUC)
Measured: 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2016 (estimated)
- Study start3 Apr 2018
- Primary completion27 Jun 2019
- Study completion27 Jun 2019
Why it stopped: No approval CA (MPA) of protocol amendment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Partum HaemorrhageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oxytone Bioscience BV
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02908126
- Sponsor's protocol ID
- OXB-002
- Status last verified
- Nov 2019
- First submitted
- 16 Sep 2016
- Last updated
- 22 Nov 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Compare Efficacy of Oxytocin Administrations on Postpartum Uterine Contractility
- ClinicalTrials.gov ID
- NCT02908126
- Acronym / sponsor ID
- OXB-002
- Conditions
- Post Partum Haemorrhage
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: No approval CA (MPA) of protocol amendment
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Oxytone Bioscience BVIndustry (pharma, biotech, devices)
- Study start
- 3 Apr 2018 (actual)
- Primary completion
- 27 Jun 2019 (actual)
- Study completion
- 27 Jun 2019 (actual)
- First posted
- 20 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oxytocin intravenous | Experimental | Drug: Oxytocinsingle dose of intravenous (IV) oxytocin |
| Oxytocin tablet | Experimental | Drug: Oxytocinsingle dose of oxytocin tablet |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OxytocinOxytocin drug | Drug | Oxytocin intravenous, Oxytocin tablet |
Primary outcome
Uterine contractility: area under the curve (AUC)
Time frame: 3 hours
Results and safety
The study was stopped early (reason given: No approval CA (MPA) of protocol amendment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Oxytocin in people with Post Partum Haemorrhage, run by Oxytone Bioscience BV at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: No approval CA (MPA) of protocol amendment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Uterine contractility: area under the curve (AUC) (time frame: 3 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2019.