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

Hellenic Society of Obstetrics and Gynecology

Status: Completed

Conditions: Cesarean Section Rates

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

Study type: Interventional

Funder types: Other

Identifiers

NCT04504500

129/29062018

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 6,029 patients

Sex: Female

Ages: 14 to 46 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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6,029 participants in 2 patient groups

Observation phase

No Intervention group

Description:

Routine practice assessment

Intervention phase

Active Comparator group

Description:

Clinical practice assessment after the application of the trial's educational, behavioral and organizational interventions

Treatment:

Behavioral: Access to live real-time statistics

Other: Local CTG interpretation meetings

Behavioral: Robson criteria usage

Other: Live real-time statistics online platform

Other: Local cesarean section meetings

Behavioral: Attendance of local cesarean section meetings

Behavioral: Reminders of proper clinical practice

Behavioral: Attendance of local CTG interpretation meetings

Behavioral: Interactive workshops and courses

Behavioral: Feedback through follow-up meetings

Behavioral: HSOG guidelines application

Other: Follow-up meetings

Other: HSOG guidelines implementation

Other: Implementation of Robson criteria classification

Other: Interactive workshops and courses training