Caesarean SectionSIMPLENCT01261676
Current Dutch Practice on Caesarean Sections: Identification of Barriers and Facilitators for Optimal Care
An observational study of Caesarean Section, run by Maastricht University Medical Center at 20 sites in Netherlands.
Trial summary
Caesarean (CS) delivery rates in the Netherlands increased from 5 to 15% the last 20 years. CSs have no clear benefit for overall neonatal outcome and are associated with higher maternal complications and high costs. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Caesarean Section
- What is being tested?
- Implementation aids
- How many people
- 1,000 participants
- Where
- 20 sitesNetherlands
- Study dates
- Dec 2010to Oct 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: 1. Development of quality indicators: 12-15 obstetricians and midwives 2. Current care study: All women (1000) who underwent a CS in one of the 20 participating hospitals during the study period (3-4 months). All hospitals participate in the Dutch consortium and consist of university teaching-, non-university teaching- and non-university-non-teaching hospitals. 3. Barrier analysis: Qualitative: 15-20 professionals and 15-20 patients from the hospitals in the upper and lower extremes of the 'adherence distribution'. Quantitative: obstetricians in the Netherlands and 200 experienced patients. 4. CBA study: depending on the outcome of phase 2 and 3 of the study, the implementation strategy will be designed for a target group with low guideline adherence and high incidence.
Who may be able to join
- A previous caesarean section in a 3-4 month time period.
Who cannot join
- Major congenital malformality
- Fetal death prior to onset of delivery
- Duration of pregnancy less than 24 weeks of gestation
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
Netherlands20 sites
Ziekenhuisgroep Twente
Almelo
Flevo Ziekenhuis
Almere Stad
Meander Medisch Centrum
Amersfoort
Academisch Medisch Centrum
Amsterdam
Gelreziekenhuizen
Apeldoorn
Rijnstate Ziekenhuis
Arnhem
Ijsselland Ziekenhuis
Capelle Aan Den Ijjsel
Catharina-ziekenhuis
Eindhoven
University Medical Centre Groningen
Groningen
Röpcke-Zweers Ziekenhuis
Hardenberg
Atrium Medisch Centrum Parkstad
Heerlen
Elkerliek Ziekenhuis
Helmond
Tergooiziekenhuizen
Hilversum
Maastricht Universitair Medisch Centrum
Maastricht
Universitair Medisch Centrum St. Radboud
Nijmegen
Orbis Medisch Centrum
Sittard
Universitair Medisch Centrum Utrecht
Utrecht
Maxima Medisch Centrum
Veldhoven
Sint Jansgasthuis
Weert
Zaans Medisch Centrum
Zaandam
About this study
Official title: Current Dutch Practice on Caesarean Sections: Identification of Barriers and Facilitators for Optimal Care.
Caesarean (CS) delivery rates in the Netherlands increased from 5 to 15% the last 20 years. CSs have no clear benefit for overall neonatal outcome and are associated with higher maternal complications and high costs. Dutch guidelines offer clear recommendations on factors that have a direct effect on the decision to perform a CS.
Hypothesis: there is incomplete adherence to the recommendations from the guidelines on CS among Dutch gynaecologists.
Read more
This study consists of four phases:
- Development of quality indicators: A set of quality indicators regarding the process, structure and outcome of care will be developed according to the RAND-modified Delphi method. A representative, national expert panel consisting of 12 to 15 obstetricians and midwives will participate.
- Current care study: The current Dutch care will be studied in 20 hospitals (N=80 gynaecologists). 1000 files on performed CSs are analyzed regarding the adherence to the developed quality indicators. To get insight into Dutch practices compared to international data, basic obstetrical data will be extracted from the delivery database.
- Barrier analysis: A barrier analysis will be carried out based on the results of the current care study. Two groups of hospitals will be identified in the upper and lower extremes of the 'adherence distribution': 5 hospitals with the lowest and 5 hospitals with the highest adherence scores. Factors that determine the decision to perform a CS or not (barriers and facilitators) will be analyzed in both groups using semi-structured interviews among 15-20 professionals and 15-20 patients. A questionnaire will be used to study the 'prevalence' of these factors among all obstetric gynaecologists in the Netherlands and among 200 patients.
- Controlled before- and-after (CBA) study: Based on the outcomes of the current care study and the barrier analysis, a tailor made implementation strategy will be developed in order to increase adherence to the CS quality indicators. Target groups will be selected with focus on women with both a high incidence of the indicator and low indicator adherence. The strategy will be executed and evaluated in a CBA-study in 12 hospitals (6 intervention, 6 control) in terms of effectiveness, experiences and costs. The sample size will be dependent on the target group and adherence to the quality indicators regarding this target group. These data will be available after performing the current care and the barrier study.
- Conditions
- Caesarean Section
- Being tested
- Implementation aids
- Keywords
- caesarean section, labour, obstetric, implementation guidelines, quality indicators
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implementation aidsOther
An implementation strategy to improve outcome for women in labour will be developed depending on the outcome of the current care study and the barrier and facilitator analysis.The strategy will be executed and evaluated in a controlled before-and-after study in 12 hospitals (6 intervention, 6 control)
| Study group | Role | What they receive |
|---|---|---|
| Caesarean section | Not described Receives: Other: Implementation aids | |
| Vaginal birth (control) | Not described Receives: Other: Implementation aids |
What is being measured
The primary outcome is the main question the study is designed to answer.
1) Development of quality indicators: development of a valid set of quality indicators for measuring current Dutch care on caesarean sections
Measured: December 2010 - October 2013
2) Current care study: The main outcome is the adherence to the quality indicators regarding the process, structure and outcome (maternal and fetal) of care
Measured: December 2010 - October 2013
3) Barrier and facilitator analysis: Identification of barriers and facilitators to perform a caesarean section
Measured: December 2010 - October 2013
4) Controlled before-and-after study: effectiveness of the implementation strategy defined as observed increase in adherence between the intervention and control hospitals and actual CS rates in both groups
Measured: December 2010 - October 2013
Secondary outcomes (4)
1) Development of quality indicators: no secondary outcomes
Measured: December 2010 - October 2013
2) Current care study: International comparison
Dutch practice as compared to international data (Robson criteria)
Measured: December 2010- October 2013
3) Barrier and facilitator analysis: no secondary outcomes
Measured: December 2010-October 2013
4) Controlled before-and-after study: experiences and satisfaction of health care providers and patients with the implementation strategy and applicability and costs of the strategy
Measured: December 2010-October 2013
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2010 (estimated)
- Study startDec 2010
- Primary completionOct 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Caesarean SectionStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- 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-control
- Time perspective
- Retrospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Responsible party
- Sponsor
- Investigators
- Hubertina CJ Scheepers, Ph.D., Principal investigator, Maastricht University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01261676
- Sponsor's protocol ID
- 09-4-047
- Other IDs
- 17100.3006
- Acronym
- SIMPLE
- Status last verified
- Oct 2012
- First submitted
- 15 Dec 2010
- Last updated
- 30 Oct 2012
- Results posted
- No
Publications
Melman S, Schoorel EN, Dirksen C, Kwee A, Smits L, de Boer F, Jonkers M, Woiski MD, Mol BW, Doornbos JP, Visser H, Huisjes AJ, Porath MM, Delemarre FM, Kuppens SM, Aardenburg R, Van Dooren IM, Vrouenraets FP, Lim FT, Kleiverda G, van der Salm PC, de Boer K, Sikkema MJ, Nijhuis JG, Hermens RP, Scheepers HC. SIMPLE: implementation of recommendations from international evidence-based guidelines on caesarean sections in the Netherlands. Protocol for a controlled before and after study. Implement Sci. 2013 Jan 3;8:3. doi: 10.1186/1748-5908-8-3.
PubMed 23281646
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Current Dutch Practice on Caesarean Sections: Identification of Barriers and Facilitators for Optimal Care.
- ClinicalTrials.gov ID
- NCT01261676
- Acronym / sponsor ID
- SIMPLE / 09-4-047
- Conditions
- Caesarean Section
- Keywords
- caesarean section, labour, obstetric, implementation guidelines, quality indicators
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Study start
- Dec 2010
- Primary completion
- Oct 2013 (estimated)
- First posted
- 16 Dec 2010 (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.
Caesarean (CS) delivery rates in the Netherlands increased from 5 to 15% the last 20 years. CSs have no clear benefit for overall neonatal outcome and are associated with higher maternal complications and high costs. Dutch guidelines offer clear recommendations on factors that have a direct effect on the decision to perform a CS.
Hypothesis: there is incomplete adherence to the recommendations from the guidelines on CS among Dutch gynaecologists.
This study consists of four phases:
- Development of quality indicators: A set of quality indicators regarding the process, structure and outcome of care will be developed according to the RAND-modified Delphi method. A representative, national expert panel consisting of 12 to 15 obstetricians and midwives will participate.
- Current care study: The current Dutch care will be studied in 20 hospitals (N=80 gynaecologists). 1000 files on performed CSs are analyzed regarding the adherence to the developed quality indicators. To get insight into Dutch practices compared to international data, basic obstetrical data will be extracted from the delivery database.
- Barrier analysis: A barrier analysis will be carried out based on the results of the current care study. Two groups of hospitals will be identified in the upper and lower extremes of the 'adherence distribution': 5 hospitals with the lowest and 5 hospitals with the highest adherence scores. Factors that determine the decision to perform a CS or not (barriers and facilitators) will be analyzed in both groups using semi-structured interviews among 15-20 professionals and 15-20 patients. A questionnaire will be used to study the 'prevalence' of these factors among all obstetric gynaecologists in the Netherlands and among 200 patients.
- Controlled before- and-after (CBA) study: Based on the outcomes of the current care study and the barrier analysis, a tailor made implementation strategy will be developed in order to increase adherence to the CS quality indicators. Target groups will be selected with focus on women with both a high incidence of the indicator and low indicator adherence. The strategy will be executed and evaluated in a CBA-study in 12 hospitals (6 intervention, 6 control) in terms of effectiveness, experiences and costs. The sample size will be dependent on the target group and adherence to the quality indicators regarding this target group. These data will be available after performing the current care and the barrier study.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Caesarean section | – | Other: Implementation aids |
| Vaginal birth (control) | – | Other: Implementation aids |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 1. Development of quality indicators: 12-15 obstetricians and midwives 2. Current care study: All women (1000) who underwent a CS in one of the 20 participating hospitals during the study period (3-4 months). All hospitals participate in the Dutch consortium and consist of university teaching-, non-university teaching- and non-university-non-teaching hospitals. 3. Barrier analysis: Qualitative: 15-20 professionals and 15-20 patients from the hospitals in the upper and lower extremes of the 'adherence distribution'. Quantitative: obstetricians in the Netherlands and 200 experienced patients. 4. CBA study: depending on the outcome of phase 2 and 3 of the study, the implementation strategy will be designed for a target group with low guideline adherence and high incidence.
Key inclusion criteria (1 listed)
- A previous caesarean section in a 3-4 month time period.
Key exclusion criteria (3 listed)
- Major congenital malformality
- Fetal death prior to onset of delivery
- Duration of pregnancy less than 24 weeks of gestation
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 aidsAn implementation strategy to improve outcome for women in labour will be developed depending on the outcome of the current care study and the barrier and facilitator analysis.The strategy will be executed and evaluated in a controlled before-and-after study in 12 hospitals (6 intervention, 6 control) | Other | Caesarean section, Vaginal birth (control) |
Primary outcome
1) Development of quality indicators: development of a valid set of quality indicators for measuring current Dutch care on caesarean sections
Time frame: December 2010 - October 2013
2) Current care study: The main outcome is the adherence to the quality indicators regarding the process, structure and outcome (maternal and fetal) of care
Time frame: December 2010 - October 2013
3) Barrier and facilitator analysis: Identification of barriers and facilitators to perform a caesarean section
Time frame: December 2010 - October 2013
4) Controlled before-and-after study: effectiveness of the implementation strategy defined as observed increase in adherence between the intervention and control hospitals and actual CS rates in both groups
Time frame: December 2010 - October 2013
4 secondary outcomes
1) Development of quality indicators: no secondary outcomes
Time frame: December 2010 - October 2013
2) Current care study: International comparison
Time frame: December 2010- October 2013
3) Barrier and facilitator analysis: no secondary outcomes
Time frame: December 2010-October 2013
4) Controlled before-and-after study: experiences and satisfaction of health care providers and patients with the implementation strategy and applicability and costs of the strategy
Time frame: December 2010-October 2013
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2012.
- Derived from this study: PubMed 23281646Melman S, Schoorel EN, Dirksen C, Kwee A, Smits L, de Boer F, Jonkers M, Woiski MD, Mol BW, Doornbos JP, Visser H, Huisjes AJ, Porath MM, Delemarre FM, Kuppens SM, Aardenburg R, Van Dooren IM, Vrouenraets FP, Lim FT, Kleiverda G, van der Salm PC, de Boer K, Sikkema MJ, Nijhuis JG, Hermens RP, Scheepers HC. SIMPLE: implementation of recommendations from international evidence-based guidelines on caesarean sections in the Netherlands. Protocol for a controlled before and after study. Implement Sci. 2013 Jan 3;8:3. doi: 10.1186/1748-5908-8-3.
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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.
Hubertina CJ Scheepers, Ph.D. principal investigator
Maastricht University Medical Center
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Caesarean Section, run by Maastricht University Medical Center at 20 sites 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 3 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 30 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites 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?
1) Development of quality indicators: development of a valid set of quality indicators for measuring current Dutch care on caesarean sections (time frame: December 2010 - October 2013). The study lists 4 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 NCT01261676, which also lists 1 linked publication.
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 30 Oct 2012.