Hemorrhage, PostpartumFluximNCT00928863
Haemorrhagia Postpartum: an Implementation Study on the NVOG Guidelines and MOET Instructions
An observational study of Hemorrhage, Postpartum, run by ZonMw: The Netherlands Organisation for Health Research and Development at 1 site in Netherlands.
Trial summary
The objectives of this study is first to asses to what extent the guidelines of the Dutch Society of Obstetrics and Gynaecology (NVOG) and the MOET (Management of Obstetric and Emergencies and Trauma) instructions for haemorrhagia postpartum have been implemented in current care in the Dutch practice. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hemorrhage, Postpartum
- What is being tested?
- implementation aids
- How many people
- 320 participants
- Where
- 1 siteNetherlands
- Study dates
- Jan 2010to Aug 2013
- Phase
- Observational
- 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 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: women with a high risk for haemorrhagia postpartum delivering in a hospital
Who may be able to join
- woman with a high risk for haemorrhagia post partum
Who cannot join
- woman who refuses to participate
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Radboud University Nijmegen Medical Centre
Nijmegen, 6500 HB
About this study
The objectives of this study is first to asses to what extent the guidelines of the Dutch Society of Obstetrics and Gynaecology (NVOG) and the MOET (Management of Obstetric and Emergencies and Trauma) instructions for haemorrhagia postpartum have been implemented in current care in the Dutch practice. Second to study barriers and facilitators for guideline adherence and to develop and test a tailored implementation strategy, based on these findings.
Read the detailed description
The most important cause of maternal morbidity in the Netherlands is Haemorrhagia post partum (HPP), with an incidence of 5% containing 10.000 women in the Netherlands a year. Introduction of an evidence-based guideline about HPP by the Dutch society of Obstetrics and Gynaecology (NVOG) and the course Management of Obstetrics Emergencies and Trauma (MOET course) did not lead to a reduction in HPP. This implies the possibility of an incomplete implementation of both the NVOG guideline and MOET-instructions.
To evaluate the implementation of the guideline and MOET instruction in the current care, measurement of the actual care will be performed in a representative sample of 20 hospitals. Before actual care can be measured, quality indicators have to be developed regarding the process, structure and outcome based on the key recommendations from the NVOG guideline on HPP and the MOET instructions. The indicator development will be performed according to the RAND-modified Delphi method .The key recommendations from the NVOG guideline on HPP and the MOET instructions will be extracted and will be tested in two rounds among an independent panel of 12-15. The selected key recommendations will be operationalized in measurable elements. In an observational multi-centre study, actual care will be measured by video monitoring the third stage of delivery and a medical record search among 320 high risk patients for HPP in 20 hospitals. Additional information for indicator adherence will be searched in the medical records of the videotaped patients. In this manner, deviations from the indicators can be outlined. This study will provide us with reliable information about current practice in the Netherlands.
A qualitative study will be performed with the aim to discover factors in detail that are "pro" or "contra" adhering to the developed HPP-indicators by focus group interviews among groups of different involved professionals and experienced patients. Subsequently, to assess the 'prevalence' of the factors mentioned in the focus group interviews, a survey with questionnaires will be performed among all Dutch gynaecologists and midwives. The data will be analyzed to assess the most frequently mentioned barriers and facilitators.
Based on the results of step 1 and 2, a tailored implementation strategy will be developed to increase the adherence to the recommendations. The different implementation elements will be tailored to the barriers and facilitators found and will probably combine interventions directed at professional and organizational level. This strategy will be implemented and evaluated in a feasibility study. The study will be performed in 3 hospitals where the effect of the implementation strategy, the adherence to the developed indicators will be measured. A process evaluation will be performed to study the experiences of the clinicians and patients with this strategy. A cost analysis of the tested implementation strategy will take place.
- Conditions
- Hemorrhage, Postpartum
- Being tested
- implementation aids
- Keywords
- haemorrhagia postpartum, implementation guidelines, maternal morbidity, management of obstetrics and trauma
- Medical subject headings
- Postpartum Hemorrhage, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
implementation aidsOther
testing a taylor made strategy for implementation NVOG guideline and MOET instruction in 3 hospitals
| Study group | Role | What they receive |
|---|---|---|
| Haemorrhagia post partum | Women with a high risk for haemorrhagia post partum. Receives: Other: implementation aids |
What is being measured
The primary outcome is the main question the study is designed to answer.
actual care study: the primary outcome measure is the adherence to the quality indicators (derived from the NVOG guideline on HPP and the MOET instructions).
Measured: 1 year
feasibility study: the primary outcome measure regarding effectiveness is the adherence to developed quality indicators.
Measured: 1 years
barrier analysis
the primary outcomes in the barrier analysis are the barriers and facilitators among patients and professional regarding adherence to the quality indicators
Measured: 1 year
Secondary outcomes (2)
actual care study: the secondary outcome measure is the outcome (e.g. the incidence of HPP) of care.
Measured: 1 year
feasibility study: the secondary outcome measures are the experiences of professionals and patients with the different elements of the implementation strategy and the changed care, and the cost of the tested strategy.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2009 (estimated)
- Study startJan 2010
- Primary completionAug 2013 (estimated)
- Study completionAug 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Hemorrhage, PostpartumStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ZonMw: The Netherlands Organisation for Health Research and Development
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rosella Hermens, Radboud University Medical Center
- Investigators
- Rosella Hermens, PhD, Principal investigator, IQ healthcare, Radboud University Nijmegen Medical Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00928863
- Sponsor's protocol ID
- 80-82315-98-09003
- Acronym
- Fluxim
- Status last verified
- May 2013
- First submitted
- 25 Jun 2009
- Last updated
- 24 May 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Woiski M, de Visser S, van Vugt H, Dijkman A, Schuitemaker N, van Meir C, Middeldorp J, Huisjes A, Mol BW, Molkenboer J, Moonen-Delarue D, Oudijk M, van Rheenen-Flach L, Rijnders R, Pernet P, Porath M, de Wit S, Grol R, Scheepers H, Hermens R. Evaluating Adherence to Guideline-Based Quality Indicators for Postpartum Hemorrhage Care in the Netherlands Using Video Analysis. Obstet Gynecol. 2018 Sep;132(3):656-667. doi: 10.1097/AOG.0000000000002781.
PubMed 30095761de Visser SM, Woiski MD, Grol RP, Vandenbussche FPHA, Hulscher MEJL, Scheepers HCJ, Hermens RPMG. Development of a tailored strategy to improve postpartum hemorrhage guideline adherence. BMC Pregnancy Childbirth. 2018 Feb 8;18(1):49. doi: 10.1186/s12884-018-1676-6.
PubMed 29422014Woiski MD, van Vugt HC, Dijkman A, Grol RP, Marcus A, Middeldorp JM, Mol BW, Mols F, Oudijk MA, Porath M, Scheepers HJ, Hermens RP. From Postpartum Haemorrhage Guideline to Local Protocol: A Study of Protocol Quality. Matern Child Health J. 2016 Oct;20(10):2160-8. doi: 10.1007/s10995-016-2050-9.
PubMed 27395381Woiski MD, Belfroid E, Liefers J, Grol RP, Scheepers HC, Hermens RP. Influencing factors for high quality care on postpartum haemorrhage in the Netherlands: patient and professional perspectives. BMC Pregnancy Childbirth. 2015 Oct 23;15:272. doi: 10.1186/s12884-015-0707-9.
PubMed 26497307Woiski MD, Hermens RP, Middeldorp JM, Kremer JA, Marcus MA, Wouters MG, Grol RP, Lotgering FK, Scheepers HC. Haemorrhagia post partum; an implementation study on the evidence-based guideline of the Dutch Society of Obstetrics and Gynaecology (NVOG) and the MOET (Managing Obstetric Emergencies and Trauma-course) instructions; the Fluxim study. BMC Pregnancy Childbirth. 2010 Jan 26;10:5. doi: 10.1186/1471-2393-10-5.
PubMed 20102607
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Haemorrhagia Postpartum: an Implementation Study on the NVOG Guidelines and MOET Instructions
- ClinicalTrials.gov ID
- NCT00928863
- Acronym / sponsor ID
- Fluxim / 80-82315-98-09003
- Conditions
- Hemorrhage, Postpartum
- Keywords
- haemorrhagia postpartum, implementation guidelines, maternal morbidity, management of obstetrics and trauma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- ZonMw: The Netherlands Organisation for Health Research and DevelopmentUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Aug 2013 (estimated)
- Study completion
- Aug 2013 (estimated)
- First posted
- 26 Jun 2009 (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.
The objectives of this study is first to asses to what extent the guidelines of the Dutch Society of Obstetrics and Gynaecology (NVOG) and the MOET (Management of Obstetric and Emergencies and Trauma) instructions for haemorrhagia postpartum have been implemented in current care in the Dutch practice. Second to study barriers and facilitators for guideline adherence and to develop and test a tailored implementation strategy, based on these findings.
Detailed description
The most important cause of maternal morbidity in the Netherlands is Haemorrhagia post partum (HPP), with an incidence of 5% containing 10.000 women in the Netherlands a year. Introduction of an evidence-based guideline about HPP by the Dutch society of Obstetrics and Gynaecology (NVOG) and the course Management of Obstetrics Emergencies and Trauma (MOET course) did not lead to a reduction in HPP. This implies the possibility of an incomplete implementation of both the NVOG guideline and MOET-instructions.
To evaluate the implementation of the guideline and MOET instruction in the current care, measurement of the actual care will be performed in a representative sample of 20 hospitals. Before actual care can be measured, quality indicators have to be developed regarding the process, structure and outcome based on the key recommendations from the NVOG guideline on HPP and the MOET instructions. The indicator development will be performed according to the RAND-modified Delphi method .The key recommendations from the NVOG guideline on HPP and the MOET instructions will be extracted and will be tested in two rounds among an independent panel of 12-15. The selected key recommendations will be operationalized in measurable elements. In an observational multi-centre study, actual care will be measured by video monitoring the third stage of delivery and a medical record search among 320 high risk patients for HPP in 20 hospitals. Additional information for indicator adherence will be searched in the medical records of the videotaped patients. In this manner, deviations from the indicators can be outlined. This study will provide us with reliable information about current practice in the Netherlands.
A qualitative study will be performed with the aim to discover factors in detail that are "pro" or "contra" adhering to the developed HPP-indicators by focus group interviews among groups of different involved professionals and experienced patients. Subsequently, to assess the 'prevalence' of the factors mentioned in the focus group interviews, a survey with questionnaires will be performed among all Dutch gynaecologists and midwives. The data will be analyzed to assess the most frequently mentioned barriers and facilitators.
Based on the results of step 1 and 2, a tailored implementation strategy will be developed to increase the adherence to the recommendations. The different implementation elements will be tailored to the barriers and facilitators found and will probably combine interventions directed at professional and organizational level. This strategy will be implemented and evaluated in a feasibility study. The study will be performed in 3 hospitals where the effect of the implementation strategy, the adherence to the developed indicators will be measured. A process evaluation will be performed to study the experiences of the clinicians and patients with this strategy. A cost analysis of the tested implementation strategy will take place.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Haemorrhagia post partum | – | Other: implementation aidsWomen with a high risk for haemorrhagia post partum. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- women with a high risk for haemorrhagia postpartum delivering in a hospital
Key inclusion criteria (1 listed)
- woman with a high risk for haemorrhagia post partum
Key exclusion criteria (1 listed)
- woman who refuses to participate
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 |
|---|---|---|
| implementation aidstesting a taylor made strategy for implementation NVOG guideline and MOET instruction in 3 hospitals | Other | Haemorrhagia post partum |
Primary outcome
actual care study: the primary outcome measure is the adherence to the quality indicators (derived from the NVOG guideline on HPP and the MOET instructions).
Time frame: 1 year
feasibility study: the primary outcome measure regarding effectiveness is the adherence to developed quality indicators.
Time frame: 1 years
barrier analysis
Time frame: 1 year
the primary outcomes in the barrier analysis are the barriers and facilitators among patients and professional regarding adherence to the quality indicators
2 secondary outcomes
actual care study: the secondary outcome measure is the outcome (e.g. the incidence of HPP) of care.
Time frame: 1 year
feasibility study: the secondary outcome measures are the experiences of professionals and patients with the different elements of the implementation strategy and the changed care, and the cost of the tested strategy.
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2013.
- Derived from this study: PubMed 30095761Woiski M, de Visser S, van Vugt H, Dijkman A, Schuitemaker N, van Meir C, Middeldorp J, Huisjes A, Mol BW, Molkenboer J, Moonen-Delarue D, Oudijk M, van Rheenen-Flach L, Rijnders R, Pernet P, Porath M, de Wit S, Grol R, Scheepers H, Hermens R. Evaluating Adherence to Guideline-Based Quality Indicators for Postpartum Hemorrhage Care in the Netherlands Using Video Analysis. Obstet Gynecol. 2018 Sep;132(3):656-667. doi: 10.1097/AOG.0000000000002781.
- Derived from this study: PubMed 29422014de Visser SM, Woiski MD, Grol RP, Vandenbussche FPHA, Hulscher MEJL, Scheepers HCJ, Hermens RPMG. Development of a tailored strategy to improve postpartum hemorrhage guideline adherence. BMC Pregnancy Childbirth. 2018 Feb 8;18(1):49. doi: 10.1186/s12884-018-1676-6.
- Derived from this study: PubMed 27395381Woiski MD, van Vugt HC, Dijkman A, Grol RP, Marcus A, Middeldorp JM, Mol BW, Mols F, Oudijk MA, Porath M, Scheepers HJ, Hermens RP. From Postpartum Haemorrhage Guideline to Local Protocol: A Study of Protocol Quality. Matern Child Health J. 2016 Oct;20(10):2160-8. doi: 10.1007/s10995-016-2050-9.
- Derived from this study: PubMed 26497307Woiski MD, Belfroid E, Liefers J, Grol RP, Scheepers HC, Hermens RP. Influencing factors for high quality care on postpartum haemorrhage in the Netherlands: patient and professional perspectives. BMC Pregnancy Childbirth. 2015 Oct 23;15:272. doi: 10.1186/s12884-015-0707-9.
- Derived from this study: PubMed 20102607Woiski MD, Hermens RP, Middeldorp JM, Kremer JA, Marcus MA, Wouters MG, Grol RP, Lotgering FK, Scheepers HC. Haemorrhagia post partum; an implementation study on the evidence-based guideline of the Dutch Society of Obstetrics and Gynaecology (NVOG) and the MOET (Managing Obstetric Emergencies and Trauma-course) instructions; the Fluxim study. BMC Pregnancy Childbirth. 2010 Jan 26;10:5. doi: 10.1186/1471-2393-10-5.
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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.
Rosella Hermens, PhD principal investigator
IQ healthcare, Radboud University Nijmegen Medical Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hemorrhage, Postpartum, run by ZonMw: The Netherlands Organisation for Health Research and Development at 1 site in Netherlands.
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: status not confirmed, as of the sponsor's last update on 24 May 2013. 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 Netherlands. 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?
Results are not available in the source record.
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?
actual care study: the primary outcome measure is the adherence to the quality indicators (derived from the NVOG guideline on HPP and the MOET instructions). (time frame: 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00928863, which also lists 5 linked publications.
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 24 May 2013.