Compare Efficacy of Oxytocin Administrations on Postpartum Uterine Contractility

Oxytone Bioscience

Status and phase

Terminated

Phase 1

Conditions

Post Partum Haemorrhage

Treatments

Drug: Oxytocin

Study type

Interventional

Funder types

Industry

Identifiers

NCT02908126

OXB-002

Details and patient eligibility

About

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.

Enrollment

4 patients

Sex

Female

Ages

18 to 40 years old

Volunteers

Accepts 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