Reducing Cesarean Section Rates and Enhancing Vaginal Delivery in Greece: a Stepped-Wedge Randomized Controlled Trial
- Conditions
- Cesarean Section Rates
- Registration Number
- NCT04504500
- Lead Sponsor
- Hellenic Society of Obstetrics and Gynecology
- Brief 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.
- Detailed 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 6029
- 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
- None
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method Cesarean section rate Admission to maternity unit to time of vaginal or cesarean birth Number of cesarean section deliveries in the study period divided by the number of live vaginal and cesarean births
- Secondary Outcome Measures
Name Time Method Maternal morbidity During labor and 40 days to 3 months after delivery Incidence of maternal complications in labor and postpartum
Perinatal and neonatal morbidity During labor and 40 days to 3 months after delivery Incidence of perinatal and neonatal complications in labor and postpartum
Trial Locations
- Locations (1)
All participating units
🇬🇷Athens, Greece
All participating units🇬🇷Athens, Greece