Current Dutch Practice on Caesarean Sections: Identification of Barriers and Facilitators for Optimal Care
- Conditions
- Caesarean Section
- Interventions
- Other: Implementation aids
- Registration Number
- NCT01261676
- Lead Sponsor
- Maastricht University Medical Center
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 1000
- A previous caesarean section in a 3-4 month time period.
- Major congenital malformality
- Fetal death prior to onset of delivery
- Duration of pregnancy less than 24 weeks of gestation
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Caesarean section Implementation aids - Vaginal birth (control) Implementation aids -
- Primary Outcome Measures
Name Time Method 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 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 3) Barrier and facilitator analysis: Identification of barriers and facilitators to perform a caesarean section 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 December 2010 - October 2013
- Secondary Outcome Measures
Name Time Method 1) Development of quality indicators: no secondary outcomes December 2010 - October 2013 2) Current care study: International comparison December 2010- October 2013 Dutch practice as compared to international data (Robson criteria)
3) Barrier and facilitator analysis: no secondary outcomes 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 December 2010-October 2013
Trial Locations
- Locations (20)
Zaans Medisch Centrum
🇳🇱Zaandam, Netherlands
Flevo Ziekenhuis
🇳🇱Almere, Netherlands
Gelreziekenhuizen
🇳🇱Apeldoorn, Netherlands
Ziekenhuisgroep Twente
🇳🇱Almelo, Netherlands
Rijnstate Ziekenhuis
🇳🇱Arnhem, Netherlands
Ijsselland Ziekenhuis
🇳🇱Capelle aan den Ijjsel, Netherlands
Catharina-ziekenhuis
🇳🇱Eindhoven, Netherlands
Röpcke-Zweers Ziekenhuis
🇳🇱Hardenberg, 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
University Medical Centre Groningen
🇳🇱Groningen, Netherlands
Sint Jansgasthuis
🇳🇱Weert, Netherlands
Atrium Medisch Centrum Parkstad
🇳🇱Heerlen, Netherlands
Meander Medisch Centrum
🇳🇱Amersfoort, Netherlands
Academisch Medisch Centrum
🇳🇱Amsterdam, Netherlands