Compare Efficacy of Oxytocin Administrations on Postpartum Uterine Contractility

NCT ID: NCT02908126

Last Updated: 2019-11-22

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-03
• Study Completion Date: 2019-06-27

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.

Conditions

Post Partum Haemorrhage

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Oxytocin intravenous

single dose of intravenous (IV) oxytocin

Group Type: EXPERIMENTAL

Oxytocin

Intervention Type: DRUG

Oxytocin drug

Oxytocin tablet

single dose of oxytocin tablet

Group Type: EXPERIMENTAL

Oxytocin

Intervention Type: DRUG

Oxytocin drug

Interventions

Oxytocin

Oxytocin drug

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Oxytone Bioscience BV

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Karolinska Institute, Danderyd hospital,Dept of Obstetrics and Gynecology

Stockholm, , Sweden

Countries

Sweden

Other Identifiers

OXB-002

Identifier Type: -

Identifier Source: org_study_id