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

  • STATUS
    Recruiting
  • End date
    Feb 13, 2023
  • participants needed
    20000
  • sponsor
    Hellenic Society of Obstetrics and Gynecology
Updated on 13 April 2022
Accepts healthy volunteers

Summary

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.

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.

Details
Condition Cesarean Section Rates
Treatment HSOG guidelines application, Interactive workshops and courses, Feedback through follow-up meetings, Robson criteria usage, Access to live real-time statistics, Attendance of local cesarean section meetings, Attendance of local CTG interpretation meetings, Reminders of proper clinical practice, HSOG guidelines implementation, Interactive workshops and courses training, Implementation of Robson criteria classification, Live real-time statistics online platform, Local cesarean section meetings, Local CTG interpretation meetings, Follow-up meetings
Clinical Study IdentifierNCT04504500
SponsorHellenic Society of Obstetrics and Gynecology
Last Modified on13 April 2022

Eligibility

Yes No Not Sure

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
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