Reducing Cesarean Section Rates and Enhancing Vaginal Delivery in Greece: a Stepped-Wedge Randomized Controlled Trial

Study Overview
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Brief Summary
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It is becoming increasingly apparent that there is an urgent need to systematically investigate the rising cesarean section (CS) rates in Greece and develop interventions to substantially reduce these rates. In this trial, to be conducted in Greece, the obstetricians will be exposed to educational, behavioral and/or organizational interventions while managing labor. The trial is expected to yield new information about effective interventions to reduce unnecessary cesarean sections in Greece, hopefully leading the way to their reduction worldwide.

Detailed Description
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The present study explains the planned implementation of a stepped-wedge trial in Greek maternity units. Twenty-two maternity units in Greece will participate in the trial involving 20,000 to 25,000 births, with two of the units entering the intervention period each month (stepped randomization). The maternity units will apply the interventions for a period of 6-16 months, depending on the time they enter the intervention stage of the trial. There will also be an initial baseline phase of the trial, lasting from 3 to 13 months; this phase will include observation and data collection of routine obstetric practices. The interventions are based on educational, behavioral and organizational modifications and will include the implementation of the Hellenic Society of Obstetrics and Gynecology (HSOG) guidelines on labor management and targeted training in cardiotocography (CTG), obstetric emergencies, and the classification of cesarean section through Robson criteria. During the trial period, the rates and indications for cesarean sections will be available to participating units on a live platform, using an anonymous reporting system. Participating obstetricians will be able to see their own and other units' performance and also get feedback on their rates. Τhe final three-month phase of the trial will be devoted to completion of questionnaires by the participating obstetricians. The total estimated duration of the trial will be 22 months. The primary outcome assessed will be the change in cesarean section rate and the secondary outcomes will be maternal and neonatal morbidity and mortality. The intervention and control periods will be compared using mixed effects logistic regression with adjustment for any underlying secular trends.

Official Title
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Reducing the Cesarean Section Rates and Enhancing Vaginal Delivery in Greece Through Educational, Behavioral and Organizational Interventions in Labor Management: a Stepped-Wedge Randomized Controlled Trial (ENGAGE Trial)

Conditions
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Cesarean Section Rates

Intervention / Treatment
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* Behavioral: HSOG guidelines application
* Behavioral: Interactive workshops and courses
* Behavioral: Feedback through follow-up meetings
* Behavioral: Robson criteria usage
* Behavioral: Access to live real-time statistics
* Behavioral: Attendance of local cesarean section meetings
* Behavioral: Attendance of local CTG interpretation meetings
* Behavioral: Reminders of proper clinical practice
* Other: HSOG guidelines implementation
* Other: Interactive workshops and courses training
* Other: Implementation of Robson criteria classification
* Other: Live real-time statistics online platform
* Other: Local cesarean section meetings
* Other: Local CTG interpretation meetings
* Other: Follow-up meetings


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A minimum of 5 years' provision of obstetric services for the participating units. Top 22 units in Greece according to the number of deliveries and the type of unit (National Health System, private, university) and the unit's willingness to participate. Up to 11 obstetricians in each unit (based on the number of deliveries and their willingness to participate) Consent obtained from all participating professionals Consent obtained from all participating women Exclusion Criteria: None

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 46 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: The trial herein discussed is a stepped-wedge cluster randomized trial involving random and sequential crossover of maternity units (clusters) from observation (routine practice, control) to intervention (educational, behavioral and organizational interventions), until all maternity units (clusters) have been exposed. The primary and secondary outcomes of the two phases (observation and intervention) are compared.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Observation phase<br>Routine practice assessment | |
| Active Comparator: Intervention phase<br>Clinical practice assessment after the application of the trial's educational, behavioral and organizational interventions | Behavioral: HSOG guidelines application<br>* In their practice, as regards the mode of delivery, obstetricians are encouraged to conform to the three guidelines and two consent forms published by the Hellenic Society of Obstetrics and Gynecology (HSOG). The members of the appointed Steering Committee and/or local opinion leaders will discuss and disseminate these guidelines among the professional staff in the respective maternity units, providing them with the opportunity to identify specific barriers, overcome them, and develop an implementation timetable.<br>Behavioral: Interactive workshops and courses<br>* The workshops and courses will give instruction in indications for cesarean section and clinical scenarios, physiology-based cardiotocography (CTG) interpretation, obstetric emergencies (with topics including breech delivery, trial of labor after cesarean, delivery of twins, induction and augmentation of labor), organization of the labor ward, as well as launching of regular cesarean section and CTG meetings with review of the patient notes. The workshops will last four days and will be conducted by experienced trainers. The expectation is that the obstetricians will gain very considerable knowledge and skills, which will enable them to subsequently follow these practices safely and competently.<br>Behavioral: Feedback through follow-up meetings<br>* Regular follow-up meetings with members of the steering committee and local opinion leaders throughout the intervention period will enhance compliance with the guidelines. Feedback with positive phrasing will be incorporated to meet local needs.<br>Behavioral: Robson criteria usage<br>* Obstetricians are set to a routine to enable them to use the Robson 10-group classification criteria for cesarean sections and obtain feedback on the unit's cesarean section rates monthly. They thus know which category is higher and can be reduced further.<br>Behavioral: Access to live real-time statistics<br>* Live real-time statistics provided by an online platform, on a regular basis, is expected to improve adherence, through regular feedback. Each unit will see other units' statistics by means of an anonymous reporting system. This repetition will create silent signals that will remind the participating obstetricians to remain on task.<br>Behavioral: Attendance of local cesarean section meetings<br>* Local cesarean section meetings will be held weekly, in each unit. The members of the steering committee or local opinion leaders may actively participate in these meetings. Local obstetricians learn to judiciously adapt standard medical practices, thereby avoiding unnecessary medical interventions. This is a way to further enhance compliance, as during the discussions the behavior expected of the obstetricians is clearly stated by the participating opinion leaders.<br>Behavioral: Attendance of local CTG interpretation meetings<br>* Local CTG interpretation meetings will be held weekly, in each unit, during which all abnormal CTG cases that led to cesarean section will be reviewed and discussed. Members of the Steering Committee or local opinion leaders may actively participate in these meetings. Obstetricians are encouraged to reflect on their medical practice through judicious physiology-based CTG interpretation.<br>Behavioral: Reminders of proper clinical practice<br>* Effective and reliable reminders concerning optimal obstetric practice will be placed in labor wards, staff rooms, patient notes, vaginal birth packages and above theater hand washers. There will be short messages with positive phrasing regarding the benefits of vaginal birth, thus reminding birth attendants to reduce unnecessary cesarean sections. Relevant SMS (short message service) will be sent to the participating obstetricians' mobiles on a regular basis, so as to motivate them via non-verbal signals.<br>Other: HSOG guidelines implementation<br>* There will be application in daily practice of three guidelines and two consent forms pertaining to the mode of delivery published by HSOG. Obstetricians are informed on evidence-based medicine in obstetrics and provided with a structured and safe approach to labor management. The members of the appointed Steering Committee and/or local opinion leaders discuss and disseminate the guidelines among the professional staff at the respective maternity units, answer questions, and make available their knowledge and experience. Adoption of guidelines by the participating unit helps to establish clear, consistent rules that are direct and simple, and obstetricians are asked to embrace fully justified medical practice.<br>* Other names: Educational and organizational intervention;Other: Interactive workshops and courses training<br>* The workshops and courses will provide instruction in indications for cesarean section and case scenarios, physiology-based CTG interpretation, obstetric emergencies (with topics including breech delivery, trial of labor after cesarean, delivery of twins, induction and augmentation of labor), organization of labor ward and launching of cesarean section and CTG meetings. This type of formal training provides problem-solving strategies, using mnemonics, that are critical in emergencies and that also aid in learning and retaining the skills being taught. Functional and social skills that directly affect decision-making and effectiveness are addressed. Thus, units adopt a continuous educational procedure for their staff, enhancing their confidence when dealing with labor emergencies and redesigning labor management plans, so as to ensure high-level obstetric services.<br>* Other names: Educational and organizational intervention;Other: Implementation of Robson criteria classification<br>* Use will be implemented of an online application embedded in the REDCap electronic database questionnaire with Robson 10-group classification criteria and feedback on the unit's cesarean section rates monthly, so as to know which category is higher and can be reduced further. This change in the unit's practice will introduce a new medical reporting and audit system that can detect unjustified medical procedures much more easily.<br>* Other names: Educational and organizational intervention;Other: Live real-time statistics online platform<br>* Live real-time statistics provided on a regular basis by an online platform will provide feedback and essential information. Each unit will see other units' statistics using an anonymous reporting system. This information can trigger self-generative learning strategies and help obstetricians to become more effective learners.<br>* Other names: Educational intervention;Other: Local cesarean section meetings<br>* Local cesarean section meetings will be held weekly in each unit. The members of the Steering Committee or local opinion leaders may actively participate in these meetings. The unit's staff can hear about both justified and unnecessary surgical procedures and draw informed conclusions as to the optimal procedure in similar cases. They will also have the opportunity to actively participate in an elaborative problem-solving discussion. These meetings when routinely conducted, provide feedback and audit resources to help improve performance and further enhance compliance.<br>* Other names: Educational and organizational intervention;Other: Local CTG interpretation meetings<br>* Local CTG interpretation meetings will be held weekly, in each unit during which all abnormal CTG cases that led to cesarean section will be reviewed and discussed. Members of the Steering Committee or local opinion leaders may actively participate in these meetings offering coaching and counseling services in decision-making. Through elaborative discussion the staff will improve their knowledge and skills in correct CTG interpretation, thus preventing unnecessary interventions, such as cesarean sections.<br>* Other names: Educational and organizational intervention;Other: Follow-up meetings<br>* Regular follow-up meetings of the participating obstetricians with members of the steering committee and local opinion leaders throughout the intervention period will enhance compliance with the guidelines. Establishment of commonly accepted practice augments the homogeneity of clinical action plans and team work in the unit.<br>* Other names: Organizational intervention;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cesarean section rate | Number of cesarean section deliveries in the study period divided by the number of live vaginal and cesarean births | Admission to maternity unit to time of vaginal or cesarean birth | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maternal morbidity | Incidence of maternal complications in labor and postpartum | During labor and 40 days to 3 months after delivery | 
| Perinatal and neonatal morbidity | Incidence of perinatal and neonatal complications in labor and postpartum | During labor and 40 days to 3 months after delivery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cesarean section, vaginal delivery, birth, Greece, maternal morbidity, perinatal morbidity, ENGAGE trial, stepped-wedge trial, intervention, guideline