Post Partum Haemorrhage
Conditions
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.
Interventions
DRUGOxytocin
Oxytocin drug
Sponsors
Oxytone Bioscience BV
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Uterine contractility: area under the curve (AUC) | 3 hours |
Countries
Sweden
Outcome results
None listed