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

Not Applicable

Completed

• Conditions: Cesarean Section Rates
• Interventions: 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

• 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.

Study Timeline

• Study First Submitted: 2020-08-05
• Study First Submitted QC: 2020-08-05
• Study First Posted: 2020-08-07
• Study Start: 2021-05-31
• Primary Completion: 2023-08-31
• Study Completion: 2023-10-31
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-21
• Last Update Posted: 2024-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 6029

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Intervention phase	HSOG guidelines application	Clinical practice assessment after the application of the trial's educational, behavioral and organizational interventions
Intervention phase	Feedback through follow-up meetings	Clinical practice assessment after the application of the trial's educational, behavioral and organizational interventions
Intervention phase	Implementation of Robson criteria classification	Clinical practice assessment after the application of the trial's educational, behavioral and organizational interventions
Intervention phase	Access to live real-time statistics	Clinical practice assessment after the application of the trial's educational, behavioral and organizational interventions
Intervention phase	Attendance of local CTG interpretation meetings	Clinical practice assessment after the application of the trial's educational, behavioral and organizational interventions
Intervention phase	Interactive workshops and courses	Clinical practice assessment after the application of the trial's educational, behavioral and organizational interventions
Intervention phase	Attendance of local cesarean section meetings	Clinical practice assessment after the application of the trial's educational, behavioral and organizational interventions
Intervention phase	HSOG guidelines implementation	Clinical practice assessment after the application of the trial's educational, behavioral and organizational interventions
Intervention phase	Robson criteria usage	Clinical practice assessment after the application of the trial's educational, behavioral and organizational interventions
Intervention phase	Reminders of proper clinical practice	Clinical practice assessment after the application of the trial's educational, behavioral and organizational interventions
Intervention phase	Local cesarean section meetings	Clinical practice assessment after the application of the trial's educational, behavioral and organizational interventions
Intervention phase	Local CTG interpretation meetings	Clinical practice assessment after the application of the trial's educational, behavioral and organizational interventions
Intervention phase	Follow-up meetings	Clinical practice assessment after the application of the trial's educational, behavioral and organizational interventions
Intervention phase	Interactive workshops and courses training	Clinical practice assessment after the application of the trial's educational, behavioral and organizational interventions
Intervention phase	Live real-time statistics online platform	Clinical practice assessment after the application of the trial's educational, behavioral and organizational interventions

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