Compare Efficacy of Oxytocin Administrations on Postpartu... | NCT02908126

Studies
Compare Efficacy of Oxytocin Administrations on Postpartum Uterine Contractility

NCT02908126

Sponsor

Oxytone Bioscience BV

Status

Terminated

Last Update Posted

Nov 22, 2019Actual

Enrollment

4Actual

Phase

Phase 1

Conditions

Post Partum Haemorrhage

Interventions

Oxytocin

Countries

Sweden

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2019

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

No approval CA (MPA) of protocol amendment

Expanded Access Info

Start Date

Apr 3, 2018Actual

Primary Completion Date

Jun 27, 2019Actual

Completion Date

Jun 27, 2019Actual

First Submitted Date

Sep 16, 2016

First Submission Date that Met QC Criteria

Sep 16, 2016

First Posted Date

Sep 20, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 20, 2019

Last Update Posted Date

Nov 22, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

4Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Oxytocin intravenous	Experimental	single dose of intravenous (IV) oxytocin	Drug: Oxytocin
Oxytocin tablet	Experimental	single dose of oxytocin tablet	Drug: Oxytocin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Oxytocin	Drug	Oxytocin drug	Oxytocin intravenous Oxytocin tablet

Measure	Description	Time Frame
Uterine contractility: area under the curve (AUC)		3 hours

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D007744	Obstetric Labor Complications
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases

ID	Term
D010909	Pituitary Hormones, Posterior
D010907	Pituitary Hormones
D036361	Peptide Hormones
D006728	Hormones