Current Dutch Practice on Caesarean Sections: Identification of Barriers and Facilitators for Optimal Care

Caesarean Section Clinical Trial

— SIMPLE  

Official title:

Current Dutch Practice on Caesarean Sections: Identification of Barriers and Facilitators for Optimal Care.

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01261676
• Other study ID #: 09-4-047
• Secondary ID: 17100.3006
• Status: Enrolling by invitation
• Phase: N/A
• First received: December 15, 2010
• Last updated: October 29, 2012
• Start date: December 2010

Study information

• Verified date: October 2012
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Observational

Clinical 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. 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:

1. 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.

2. 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.

3. 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.

4. 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 1000
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• A previous caesarean section in a 3-4 month time period.

Exclusion Criteria:

• Major congenital malformality

• Fetal death prior to onset of delivery

• Duration of pregnancy less than 24 weeks of gestation

Study Design

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Caesarean Section

Intervention

Other:
• Implementation aids
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)

Locations

Country	Name	City	State
Netherlands	Ziekenhuisgroep Twente	Almelo
Netherlands	Flevo Ziekenhuis	Almere
Netherlands	Meander Medisch Centrum	Amersfoort
Netherlands	Academisch Medisch Centrum	Amsterdam
Netherlands	Gelreziekenhuizen	Apeldoorn
Netherlands	Rijnstate Ziekenhuis	Arnhem
Netherlands	Ijsselland Ziekenhuis	Capelle aan den Ijjsel
Netherlands	Catharina-ziekenhuis	Eindhoven
Netherlands	University Medical Centre Groningen	Groningen
Netherlands	Röpcke-Zweers Ziekenhuis	Hardenberg
Netherlands	Atrium Medisch Centrum Parkstad	Heerlen
Netherlands	Elkerliek Ziekenhuis	Helmond
Netherlands	Tergooiziekenhuizen	Hilversum
Netherlands	Maastricht Universitair Medisch Centrum	Maastricht
Netherlands	Universitair Medisch Centrum St. Radboud	Nijmegen
Netherlands	Orbis Medisch Centrum	Sittard
Netherlands	Universitair Medisch Centrum Utrecht	Utrecht
Netherlands	Maxima Medisch Centrum	Veldhoven
Netherlands	Sint Jansgasthuis	Weert
Netherlands	Zaans Medisch Centrum	Zaandam

Sponsors (2)

Lead Sponsor	Collaborator
Maastricht University Medical Center	ZonMw: The Netherlands Organisation for Health Research and Development

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	1) Development of quality indicators: development of a valid set of quality indicators for measuring current Dutch care on caesarean sections		December 2010 - October 2013	No
Primary	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		December 2010 - October 2013	No
Primary	3) Barrier and facilitator analysis: Identification of barriers and facilitators to perform a caesarean section		December 2010 - October 2013	No
Primary	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		December 2010 - October 2013	No
Secondary	1) Development of quality indicators: no secondary outcomes		December 2010 - October 2013	No
Secondary	2) Current care study: International comparison	Dutch practice as compared to international data (Robson criteria)	December 2010- October 2013	No
Secondary	3) Barrier and facilitator analysis: no secondary outcomes		December 2010-October 2013	No
Secondary	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		December 2010-October 2013	No

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