Compare Efficacy of Oxytocin Administrations on Postpartum Uterine Contractility

• Status: Terminated
• Trial end date: 2019-06-27
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Oxytone Bioscience BV
• Treatments: Oxytocin

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