Compare Efficacy of Oxytocin Administrations on Postpartum Uterine Contractility

Phase 1

Terminated

• Conditions: Post Partum Haemorrhage
• Interventions: Drug: Oxytocin

• Registration Number: NCT02908126
• Lead Sponsor: Oxytone Bioscience BV

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-09-16
• Study First Submitted QC: 2016-09-16
• Study First Posted: 2016-09-20
• Study Start: 2018-04-03
• Primary Completion: 2019-06-27
• Study Completion: 2019-06-27
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-20
• Last Update Posted: 2019-11-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 4

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oxytocin intravenous	Oxytocin	single dose of intravenous (IV) oxytocin
Oxytocin tablet	Oxytocin	single dose of oxytocin tablet

Primary Outcome Measures

Name	Time	Method
Uterine contractility: area under the curve (AUC)	3 hours

Trial Locations

Locations (1)

Karolinska Institute, Danderyd hospital,Dept of Obstetrics and Gynecology; 🇸🇪 Stockholm, Sweden