Compare Efficacy of Oxytocin Administrations on Postpartum Uterine Contractility

NCT02908126 | Terminated Phase 1

• 1 other identifier: OXB-002
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Uterine contractility: area under the curve (AUC)

  3 hours

Study Arms (2)

Oxytocin intravenous

EXPERIMENTAL

single dose of intravenous (IV) oxytocin

Drug: Oxytocin

Oxytocin tablet

EXPERIMENTAL

single dose of oxytocin tablet

Drug: Oxytocin

Interventions

Oxytocin DRUG

Oxytocin drug

Oxytocin intravenous; Oxytocin tablet

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Oxytone Bioscience BV: lead

Study Sites (1)

Karolinska Institute, Danderyd hospital,Dept of Obstetrics and Gynecology

Stockholm, Sweden

Location

MeSH Terms

Conditions

Postpartum Hemorrhage

Interventions

Oxytocin

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2016
• First Posted: September 20, 2016
• Study Start: April 3, 2018
• Primary Completion: June 27, 2019
• Study Completion: June 27, 2019
• Last Updated: November 22, 2019

Record last verified: 2019-11

Locations

SE (1)