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

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
ZonMw: The Netherlands Organisation for Health Research and Development
Information provided by (Responsible Party):
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT01261676
First received: December 15, 2010
Last updated: October 29, 2012
Last verified: October 2012
  Purpose

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.

Condition Intervention
Caesarean Section
Other: Implementation aids

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Retrospective
Official Title: Current Dutch Practice on Caesarean Sections: Identification of Barriers and Facilitators for Optimal Care.

Resource links provided by NLM:


Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 3) Barrier and facilitator analysis: Identification of barriers and facilitators to perform a caesarean section [ Time Frame: December 2010 - October 2013 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 1) Development of quality indicators: no secondary outcomes [ Time Frame: December 2010 - October 2013 ] [ Designated as safety issue: No ]
  • 2) Current care study: International comparison [ Time Frame: December 2010- October 2013 ] [ Designated as safety issue: No ]
    Dutch practice as compared to international data (Robson criteria)

  • 3) Barrier and facilitator analysis: no secondary outcomes [ Time Frame: December 2010-October 2013 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 1000
Study Start Date: December 2010
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Caesarean section 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)
Vaginal birth (control) 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)

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01261676

Locations
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, Netherlands
Sponsors and Collaborators
Maastricht University Medical Center
ZonMw: The Netherlands Organisation for Health Research and Development
Investigators
Principal Investigator: Hubertina CJ Scheepers, Ph.D. Maastricht University Medical Center
  More Information

Additional Information:
No publications provided by Maastricht University Medical Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT01261676     History of Changes
Other Study ID Numbers: 09-4-047, 17100.3006
Study First Received: December 15, 2010
Last Updated: October 29, 2012
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Maastricht University Medical Center:
caesarean section
labour, obstetric
implementation guidelines
quality indicators

ClinicalTrials.gov processed this record on August 27, 2014