- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04420169
Uniform Communication by Midwives in Preparation for an IVF Treatment (UNCOVeR)
February 13, 2023 updated by: University Hospital, Ghent
Dutch-speaking women who are about to start an IVF treatment will be approached.
If they are willing to participate in the study, they will receive an email with a link to an online questionnaire.
This questionnaire will evaluate the communication by the midwive in preparation for an IVF treatment.
When 50 women have completed the questionnaire a standardized communication protocol will be enrolled.
Once all midwives are trained, 50 other IVF patients will be asked to complete the slightly adapted post questionnaire.The data from both questionnaires will be compared.
Study Overview
Study Type
Observational
Enrollment (Actual)
105
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Gent, Belgium, 9000
- Ghent University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Probability Sample
Study Population
Dutch-speaking women who are about to start an IVF treatment at our department.
Description
Inclusion Criteria:
- women who are about to start an IVF treatment at our department
Exclusion Criteria:
- non-Dutch speaking
- women who are counseled by one of the midwives involved in the design of this study
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
PRE implementation communication protocol
|
A digital questionnaire to evaluate the communication by midwives will be send out to IVF patients
|
|
POST implementation communication protocol
|
A digital questionnaire to evaluate the communication by midwives will be send out to IVF patients
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
How do patients evaluate the communication by the midwife in anticipation of the IVF treatment cycle?
Time Frame: About 20 weeks counting from the launch of each questionnaire or earlier if the target of 50 patients is reached sooner
|
Self created questionnaire (no scale)
|
About 20 weeks counting from the launch of each questionnaire or earlier if the target of 50 patients is reached sooner
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
May 1, 2016
Primary Completion (ACTUAL)
December 1, 2021
Study Completion (ACTUAL)
December 1, 2021
Study Registration Dates
First Submitted
June 3, 2020
First Submitted That Met QC Criteria
June 3, 2020
First Posted (ACTUAL)
June 9, 2020
Study Record Updates
Last Update Posted (ESTIMATE)
February 14, 2023
Last Update Submitted That Met QC Criteria
February 13, 2023
Last Verified
February 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- B670201627388
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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