Spontaneous AbortionKAP-abortionNCT02657200
Knowledge, Attitude and Practices of Flemish Midwifes Regarding Spontaneous Abortion
A study testing survey in people with Spontaneous Abortion, run by VakgroepVolksgezondheidEnEerstelijnszorg at 1 site in Belgium.
Trial summary
KAP-study in Flemish midwives with intramural employment Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Spontaneous Abortion
- What is being tested?
- survey
- How many people
- 647 participants
- Where
- 1 siteBelgium
- Study dates
- Sep 2015to Sep 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- midwives who are employed within a Flemish hospital in one of the following departments: maternity, maternal intensive care, (intensive) neonatology, reproductive medicine, gynaecology, delivery and prenatal care
Who cannot join
- all others
Trial locations and contacts
1 site in 1 country.
About this study
KAP-study in Flemish midwives with intramural employment
Read the detailed description
The study will be conducted using a self designed questionnaire administered in midwives who are employed within a Flemish hospital in one of the following departments: maternity, maternal intensive care, (intensive) neonatology, reproductive medicine, gynaecology, delivery and prenatal care. The questionnaire assesses the knowledge, attitude and practices of the midwives regarding spontaneous abortion.
- Conditions
- Spontaneous Abortion
- Being tested
- survey
- Keywords
- miscarriage, Flanders, spontaneous abortion, KAP, midwives
- Medical subject headings
- Abortion, Spontaneous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surveyOther
questionnaire assessing the knowlegde, attitude and practices regarding spontaneous abortion
What is being measured
The primary outcome is the main question the study is designed to answer.
knowledge, attitude and practices regarding spontaneous abortion
Based on previous published KAP-studies, a questionnaire was designed and tested using a single Delphi procedure with experts and lay persons. The knowledge items include questions on the definition, treatment, side effects, risk factors and legal aspects of spontaneous abortion. The attitude items include questions about the attitude of midwives when confronted with women with spontaneous abortion, and how they perceive the role of midwives in delivering various aspects of care to women with spontaneous abortion. The practices items include questions about the extent to which midwives are confronted with women with spontaneous abortion, and about the characteristics of these cases. In addition, midwives are asked about the availability of training and protocols to deliver care to women with spontaneous abortion. Each item will be treated as a categorical variable. A sum score will be calculated counting the correct answers of the knowledge questions.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2016 (estimated)
- Study startSep 2015
- Primary completionJul 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spontaneous AbortionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 647 participants (actual)
Sponsor and investigators
- Lead sponsor
- VakgroepVolksgezondheidEnEerstelijnszorg
- Sponsor type
- University, hospital or other
- Collaborators
- Odisee
- Responsible party
- Sponsor-investigator, VakgroepVolksgezondheidEnEerstelijnszorg, University Ghent
- Investigators
- Els Clays, Phd, Principal investigator, University Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02657200
- Sponsor's protocol ID
- EC/2015/0589 AND EC/2015/0590
- Acronym
- KAP-abortion
- Status last verified
- May 2021
- First submitted
- 17 Dec 2015
- Last updated
- 21 May 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Knowledge, Attitude and Practices of Flemish Midwifes Regarding Spontaneous Abortion
- ClinicalTrials.gov ID
- NCT02657200
- Acronym / sponsor ID
- KAP-abortion / EC/2015/0589 AND EC/2015/0590
- Conditions
- Spontaneous Abortion
- Keywords
- miscarriage, Flanders, spontaneous abortion, KAP, midwives
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 647 participants (actual)
- Lead sponsor
- VakgroepVolksgezondheidEnEerstelijnszorgUniversity, hospital or other
- Collaborators
- Odisee
- Study start
- Sep 2015 (actual)
- Primary completion
- Jul 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 15 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
KAP-study in Flemish midwives with intramural employment
Detailed description
The study will be conducted using a self designed questionnaire administered in midwives who are employed within a Flemish hospital in one of the following departments: maternity, maternal intensive care, (intensive) neonatology, reproductive medicine, gynaecology, delivery and prenatal care. The questionnaire assesses the knowledge, attitude and practices of the midwives regarding spontaneous abortion.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (participant)
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- midwives who are employed within a Flemish hospital in one of the following departments: maternity, maternal intensive care, (intensive) neonatology, reproductive medicine, gynaecology, delivery and prenatal care
Key exclusion criteria (1 listed)
- all others
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| surveyquestionnaire assessing the knowlegde, attitude and practices regarding spontaneous abortion | Other | – |
Primary outcome
knowledge, attitude and practices regarding spontaneous abortion
Time frame: 6 months
Based on previous published KAP-studies, a questionnaire was designed and tested using a single Delphi procedure with experts and lay persons. The knowledge items include questions on the definition, treatment, side effects, risk factors and legal aspects of spontaneous abortion. The attitude items include questions about the attitude of midwives when confronted with women with spontaneous abortion, and how they perceive the role of midwives in delivering various aspects of care to women with spontaneous abortion. The practices items include questions about the extent to which midwives are confronted with women with spontaneous abortion, and about the characteristics of these cases. In addition, midwives are asked about the availability of training and protocols to deliver care to women with spontaneous abortion. Each item will be treated as a categorical variable. A sum score will be calculated counting the correct answers of the knowledge questions.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Els Clays, Phd principal investigator
University Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing survey in people with Spontaneous Abortion, run by VakgroepVolksgezondheidEnEerstelijnszorg at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
knowledge, attitude and practices regarding spontaneous abortion (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2021.