Compare Efficacy of Oxytocin Administrations on Postpartum Uterine Contractility

Post Partum Haemorrhage Clinical Trial

Official title:

Compare Efficacy of Oxytocin Administrations on Postpartum Uterine Contractility

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02908126
• Other study ID #: OXB-002
• Status: Terminated
• Phase: Phase 1
• Start date: April 3, 2018
• Est. completion date: June 27, 2019

Study information

• Verified date: November 2019
• Source: Oxytone Bioscience BV
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: June 27, 2019
• Est. primary completion date: June 27, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Hemorrhage
• Post Partum Haemorrhage
• Postpartum Hemorrhage

Intervention

Drug:
• Oxytocin
Oxytocin drug

Locations

Country	Name	City	State
Sweden	Karolinska Institute, Danderyd hospital,Dept of Obstetrics and Gynecology	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Oxytone Bioscience BV

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Uterine contractility: area under the curve (AUC)		3 hours