Go to the SIMPLE II website.
Caesarean Section IMPLEmentation (SIMPLE) II Study:
A matched clustered interventioncontrolled before-and-after trial for evaluating a decision aid for mode of delivery after previous caesarean section
Pregnant women with a history of a cesarean section (CS) have to decide on mode of delivery in their current pregnancy. The options are a repeat CS, or an intended vaginal birth after cesarean (VBAC). An intended VBAC results in 70-75% in a vaginal delivery and consequently results in 25-30% in an (emergency) CS. When no contra-indication for an intended VBAC exists, both options should be offered. The Section IMPLEmentation study (SIMPLE) study measured current Dutch care on CSs by comparing current care with optimal care as described in national and international guidelines. The indicators with the lowest guideline adherence were indicators on counseling of pregnant women with a previous CS. The aim of the current study is to execute and evaluate the effectiveness of the guideline-implementation strategy, a decision aid (DA) for mode of delivery after previous CS, in increasing guideline adherence while not leading to a decrease in vaginal birth after caesarean (VBAC)-rate.
The trial design is a controlled before-and-after (CBA) trial. The intervention will be introduced on hospital level. Participating hospitals will be matched into pairs: one intervention and one control hospital.
Twelve hospitals will be enrolled in this study. These hospitals are selected form the pool of hospitals that was enrolled previously in the SIMPLE study. All hospitals were matched with regard to two criteria: intended VBAC-rate (less than 60% intended VBAC (low), 60-80% intended VBAC (mean) and more than 80% intended VBAC (high)) and hospital type (university teaching hospitals, non-university teaching hospitals and non-university, non-teaching hospitals). Six matched pairs (one intervention and one control) will be selected for participation in the current study.
Participants will be selected based on the following criteria:
- Pregnant women who have had one previous CS
- Singleton in cephalic position
- Contra-indication for a vaginal delivery
Since the study will be carried out on hospital-level and concerns regular care, all patients who meet the study criteria will be included in the trial. Additionally, patients will be asked to consent for filling in questionnaires. For the questionnaires, additional inclusion-criteria apply: 1) ability to read the Dutch language and 2) aged 18 years or older.
The implementation strategy consists of two elements: 1) training of healthcare professionals, 2) the patient DA.
Usual care comprises a regular consultation with a gynecologist for counseling on mode of delivery after a previous CS. This consultation usually takes place at 36 weeks GA, but local policy can vary between hospitals.
The main study-outcomes are 1) a non decreasing VBAC-rate and 2) adherence to the in SIMPLE I developed quality indicators with regard to counseling on mode of delivery after previous CS. Secondary study outcomes are experiences of patients and providers with the implementation strategy and costs of the strategy. The cost-analysis consists of three aspects: 1) the costs of the development of the implementation strategy; 2) the costs of implementing the strategy and 3) the costs of (possible) shift in CS rate.
The sample size calculation is based on primary outcome measure one: VBAC-rate. A non-inferiority limit of 10% was chosen, with an alpha of 0.05 and a beta of 0.20, we estimated the inter correlation coefficient (ICC) to be 0.2. The estimated sample size, corrected for cluster variation, was 400 per study-arm. Twelve hospitals will be enrolled in this study with a mean of 1000 labors per hospital per year and an estimated 7% of the obstetric population that will be enrolled in this study, the estimated study-duration is twelve months.
Intervention study: 12 months
Data analysis: 3 months
Dr. H.C.J. Scheepers, Maastricht UMC
Dr. R.P.M.G. Hermens, IQ Healthcare Nijmegen
ZonMW - www.ZonMW.nl
Dossier nr: 80-82315-97-10005
E.Vankan , MD
Maastricht Universitair Medisch Centrum+
P. Debyelaan 28
6229 HX Maastricht
Tel: 043 3874768
General study information: firstname.lastname@example.org