Cesarean Section RatesENGAGENCT04504500
Reducing Cesarean Section Rates and Enhancing Vaginal Delivery in Greece: a Stepped-Wedge Randomized Controlled Trial
A study testing HSOG guidelines application, Interactive workshops and courses and Feedback through follow-up meetings in people with Cesarean Section Rates, run by Hellenic Society of Obstetrics and Gynecology at 1 site in Greece.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 to 46 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cesarean Section Rates
- What is being tested?
- HSOG guidelines application, Interactive workshops and courses and Feedback through follow-up meetings
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6,029 participants
- Where
- 1 siteGreece
- Study dates
- 31 May 2021to 31 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 46 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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)
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.
Read the 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.
- Conditions
- Cesarean Section Rates
- Being tested
- HSOG guidelines application, Interactive workshops and courses, Feedback through follow-up meetings, Robson criteria usage, Access to live real-time statistics
- Keywords
- cesarean section, vaginal delivery, birth, Greece, maternal morbidity, perinatal morbidity, ENGAGE trial, stepped-wedge trial, intervention, guideline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HSOG guidelines applicationBehavioural
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.
Interactive workshops and coursesBehavioural
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.
Feedback through follow-up meetingsBehavioural
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.
Robson criteria usageBehavioural
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.
Access to live real-time statisticsBehavioural
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.
Attendance of local cesarean section meetingsBehavioural
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.
Attendance of local CTG interpretation meetingsBehavioural
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.
Reminders of proper clinical practiceBehavioural
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.
HSOG guidelines implementationOther
Also called Educational and organizational intervention
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.
Interactive workshops and courses trainingOther
Also called Educational and organizational intervention
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.
Implementation of Robson criteria classificationOther
Also called Educational and organizational intervention
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.
Live real-time statistics online platformOther
Also called Educational intervention
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.
Local cesarean section meetingsOther
Also called Educational and organizational intervention
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.
Local CTG interpretation meetingsOther
Also called Educational and organizational intervention
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.
Follow-up meetingsOther
Also called Organizational intervention
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.
| Study group | Role | What they receive |
|---|---|---|
| Observation phase | No intervention | Routine practice assessment |
| Intervention phase | Active comparator | Clinical practice assessment after the application of the trial's educational, behavioral and organizational interventions Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cesarean section rate
Number of cesarean section deliveries in the study period divided by the number of live vaginal and cesarean births
Measured: Admission to maternity unit to time of vaginal or cesarean birth
Secondary outcomes (2)
Maternal morbidity
Incidence of maternal complications in labor and postpartum
Measured: During labor and 40 days to 3 months after delivery
Perinatal and neonatal morbidity
Incidence of perinatal and neonatal complications in labor and postpartum
Measured: During labor and 40 days to 3 months after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2020
- Study start31 May 2021
- Primary completion31 Aug 2023
- Study completion31 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Cesarean Section RatesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- 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 blind
- Who is masked
- Outcomes assessor
- Enrolment
- 6,029 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hellenic Society of Obstetrics and Gynecology
- Sponsor type
- University, hospital or other
- Collaborators
- St George's, University of London, A. G. Leventis Foundation, National and Kapodistrian University of Athens
- Responsible party
- Sponsor
- Investigators
- Nikolaos Vrachnis, Prof Ob/Gyn, Principal investigator, Hellenic Society of Obstetrics and Gynecology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04504500
- Sponsor's protocol ID
- 129/29062018
- Acronym
- ENGAGE
- Status last verified
- Jan 2024
- First submitted
- 5 Aug 2020
- Last updated
- 23 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Study data may be shared upon chief investigator's decision after reasonable request and up to 8 year after the conclusion of the trial.
Publications
Vrachnis N, Vlachadis N, Iliodromiti Z, Vlachadi M, Creatsas G. Greece's birth rates and the economic crisis. Lancet. 2014 Feb 22;383(9918):692-3. doi: 10.1016/S0140-6736(14)60252-X. No abstract available.
PubMed 24560050Betran AP, Torloni MR, Zhang JJ, Gulmezoglu AM; WHO Working Group on Caesarean Section. WHO Statement on Caesarean Section Rates. BJOG. 2016 Apr;123(5):667-70. doi: 10.1111/1471-0528.13526. Epub 2015 Jul 22. No abstract available.
PubMed 26681211Vlachadis N, Vrachnis N, Economou E. Fertility treatments and multiple births in the United States. N Engl J Med. 2014 Mar 13;370(11):1069-70. doi: 10.1056/NEJMc1400242. No abstract available.
PubMed 24620878Betran AP, Ye J, Moller AB, Zhang J, Gulmezoglu AM, Torloni MR. The Increasing Trend in Caesarean Section Rates: Global, Regional and National Estimates: 1990-2014. PLoS One. 2016 Feb 5;11(2):e0148343. doi: 10.1371/journal.pone.0148343. eCollection 2016.
PubMed 26849801Vlachadis N, Iliodromiti Z, Creatsas G, Vrachnis N. Preterm birth time trends in Europe: the worrying case of Greece. BJOG. 2014 Feb;121(3):372-3. doi: 10.1111/1471-0528.12529. No abstract available.
PubMed 24428453The Lancet. Stemming the global caesarean section epidemic. Lancet. 2018 Oct 13;392(10155):1279. doi: 10.1016/S0140-6736(18)32394-8. No abstract available.
PubMed 30322560Vrachnis N, Iliodromiti S, Samoli E, Iliodromiti Z, Dendrinos S, Creatsas G. Maternal mortality in Greece, 1996-2006. Int J Gynaecol Obstet. 2011 Oct;115(1):16-9. doi: 10.1016/j.ijgo.2011.04.014. Epub 2011 Jul 23.
PubMed 21788018Chen I, Opiyo N, Tavender E, Mortazhejri S, Rader T, Petkovic J, Yogasingam S, Taljaard M, Agarwal S, Laopaiboon M, Wasiak J, Khunpradit S, Lumbiganon P, Gruen RL, Betran AP. Non-clinical interventions for reducing unnecessary caesarean section. Cochrane Database Syst Rev. 2018 Sep 28;9(9):CD005528. doi: 10.1002/14651858.CD005528.pub3.
PubMed 30264405Vrachnis N, Vlachadis N. Maternal mortality estimates. Lancet. 2014 Dec 20;384(9961):2210. doi: 10.1016/S0140-6736(14)62423-5. Epub 2014 Dec 19. No abstract available.
PubMed 25625395Hussey MA, Hughes JP. Design and analysis of stepped wedge cluster randomized trials. Contemp Clin Trials. 2007 Feb;28(2):182-91. doi: 10.1016/j.cct.2006.05.007. Epub 2006 Jul 7.
PubMed 16829207Vlachadis N, Vrachnis N, Tsikouras P, Mastorakos G, Iliodromiti Z. Birth rates by maternal age in Greece: background, trends and future perspectives. J Reprod Med. 2015 Mar-Apr;60(3-4):183-4. No abstract available.
PubMed 25898486Vrachnis N, Antonakopoulos N, von Dadelszen P, Vidler M, Maroudias G, Bone J, Sandhu A, Loukas N, Magee L, Roussos N, Kassaris S, Fotiou A, Zygouris D, Adonakis G, Akrivis C, Antsaklis A, Athanasiadis A, Bontis N, Daniilidis A, Daponte A, Daskalakis G, Deligeoroglou E, Dinas K, Drakakis P, Gerede A, Grimbizis G, Iacovidou N, Kambas N, Katasos T, Katsetos C, Katsikis I, Makrigiannakis A, Matalliotakis M, Messini C, Mikos T, Nikolettos N, Pados G, Paschopoulos M, Patsouras K, Siahanidou S, Sioulas V, Skentou C, Stavros S, Temmerman M, Tsikouras P, Tsitsis V, Vlahos N, Rodolakis A, Papageorghiou A, Loutradis D. ENhancinG vAGinal dElivery in Greece through educational and behavioral interventions among maternity care providers regarding labor management: the ENGAGE stepped-wedge randomized prospective trial protocol. Trials. 2024 Aug 19;25(1):548. doi: 10.1186/s13063-024-08263-x.
PubMed 39155367
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT04504500
- Acronym / sponsor ID
- ENGAGE / 129/29062018
- Conditions
- Cesarean Section Rates
- Keywords
- cesarean section, vaginal delivery, birth, Greece, maternal morbidity, perinatal morbidity, ENGAGE trial, stepped-wedge trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6,029 participants (actual)
- Lead sponsor
- Hellenic Society of Obstetrics and GynecologyUniversity, hospital or other
- Collaborators
- St George's, University of London, A. G. Leventis Foundation, National and Kapodistrian University of Athens
- Study start
- 31 May 2021 (actual)
- Primary completion
- 31 Aug 2023 (actual)
- Study completion
- 31 Oct 2023 (actual)
- First posted
- 7 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Observation phase | No intervention | –Routine practice assessment |
| Intervention phase | Active comparator | 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 meetingsClinical practice assessment after the application of the trial's educational, behavioral and organizational interventions |
Who may qualify
- Ages
- 14 to 46 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HSOG guidelines applicationIn 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. | Behavioural | Intervention phase |
| Interactive workshops and coursesThe 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. | Behavioural | Intervention phase |
| Feedback through follow-up meetingsRegular 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. | Behavioural | Intervention phase |
| Robson criteria usageObstetricians 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. | Behavioural | Intervention phase |
| Access to live real-time statisticsLive 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. | Behavioural | Intervention phase |
| Attendance of local cesarean section meetingsLocal 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. | Behavioural | Intervention phase |
| Attendance of local CTG interpretation meetingsLocal 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. | Behavioural | Intervention phase |
| Reminders of proper clinical practiceEffective 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. | Behavioural | Intervention phase |
| HSOG guidelines implementationAlso: Educational and organizational interventionThere 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. | Other | Intervention phase |
| Interactive workshops and courses trainingAlso: Educational and organizational interventionThe 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. | Other | Intervention phase |
| Implementation of Robson criteria classificationAlso: Educational and organizational interventionUse 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. | Other | Intervention phase |
| Live real-time statistics online platformAlso: Educational interventionLive 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. | Other | Intervention phase |
| Local cesarean section meetingsAlso: Educational and organizational interventionLocal 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. | Other | Intervention phase |
| Local CTG interpretation meetingsAlso: Educational and organizational interventionLocal 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. | Other | Intervention phase |
| Follow-up meetingsAlso: Organizational interventionRegular 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. | Other | Intervention phase |
Primary outcome
Cesarean section rate
Time frame: 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
2 secondary outcomes
Maternal morbidity
Time frame: During labor and 40 days to 3 months after delivery
Perinatal and neonatal morbidity
Time frame: During labor and 40 days to 3 months after delivery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2024.
- Background: PubMed 24560050Vrachnis N, Vlachadis N, Iliodromiti Z, Vlachadi M, Creatsas G. Greece's birth rates and the economic crisis. Lancet. 2014 Feb 22;383(9918):692-3. doi: 10.1016/S0140-6736(14)60252-X. No abstract available.
- Background: PubMed 26681211Betran AP, Torloni MR, Zhang JJ, Gulmezoglu AM; WHO Working Group on Caesarean Section. WHO Statement on Caesarean Section Rates. BJOG. 2016 Apr;123(5):667-70. doi: 10.1111/1471-0528.13526. Epub 2015 Jul 22. No abstract available.
- Background: PubMed 24620878Vlachadis N, Vrachnis N, Economou E. Fertility treatments and multiple births in the United States. N Engl J Med. 2014 Mar 13;370(11):1069-70. doi: 10.1056/NEJMc1400242. No abstract available.
- Background: PubMed 26849801Betran AP, Ye J, Moller AB, Zhang J, Gulmezoglu AM, Torloni MR. The Increasing Trend in Caesarean Section Rates: Global, Regional and National Estimates: 1990-2014. PLoS One. 2016 Feb 5;11(2):e0148343. doi: 10.1371/journal.pone.0148343. eCollection 2016.
- Background: PubMed 24428453Vlachadis N, Iliodromiti Z, Creatsas G, Vrachnis N. Preterm birth time trends in Europe: the worrying case of Greece. BJOG. 2014 Feb;121(3):372-3. doi: 10.1111/1471-0528.12529. No abstract available.
- Background: PubMed 30322560The Lancet. Stemming the global caesarean section epidemic. Lancet. 2018 Oct 13;392(10155):1279. doi: 10.1016/S0140-6736(18)32394-8. No abstract available.
- Background: PubMed 21788018Vrachnis N, Iliodromiti S, Samoli E, Iliodromiti Z, Dendrinos S, Creatsas G. Maternal mortality in Greece, 1996-2006. Int J Gynaecol Obstet. 2011 Oct;115(1):16-9. doi: 10.1016/j.ijgo.2011.04.014. Epub 2011 Jul 23.
- Background: PubMed 30264405Chen I, Opiyo N, Tavender E, Mortazhejri S, Rader T, Petkovic J, Yogasingam S, Taljaard M, Agarwal S, Laopaiboon M, Wasiak J, Khunpradit S, Lumbiganon P, Gruen RL, Betran AP. Non-clinical interventions for reducing unnecessary caesarean section. Cochrane Database Syst Rev. 2018 Sep 28;9(9):CD005528. doi: 10.1002/14651858.CD005528.pub3.
- Background: PubMed 25625395Vrachnis N, Vlachadis N. Maternal mortality estimates. Lancet. 2014 Dec 20;384(9961):2210. doi: 10.1016/S0140-6736(14)62423-5. Epub 2014 Dec 19. No abstract available.
- Background: PubMed 16829207Hussey MA, Hughes JP. Design and analysis of stepped wedge cluster randomized trials. Contemp Clin Trials. 2007 Feb;28(2):182-91. doi: 10.1016/j.cct.2006.05.007. Epub 2006 Jul 7.
- Background: PubMed 25898486Vlachadis N, Vrachnis N, Tsikouras P, Mastorakos G, Iliodromiti Z. Birth rates by maternal age in Greece: background, trends and future perspectives. J Reprod Med. 2015 Mar-Apr;60(3-4):183-4. No abstract available.
- Derived from this study: PubMed 39155367Vrachnis N, Antonakopoulos N, von Dadelszen P, Vidler M, Maroudias G, Bone J, Sandhu A, Loukas N, Magee L, Roussos N, Kassaris S, Fotiou A, Zygouris D, Adonakis G, Akrivis C, Antsaklis A, Athanasiadis A, Bontis N, Daniilidis A, Daponte A, Daskalakis G, Deligeoroglou E, Dinas K, Drakakis P, Gerede A, Grimbizis G, Iacovidou N, Kambas N, Katasos T, Katsetos C, Katsikis I, Makrigiannakis A, Matalliotakis M, Messini C, Mikos T, Nikolettos N, Pados G, Paschopoulos M, Patsouras K, Siahanidou S, Sioulas V, Skentou C, Stavros S, Temmerman M, Tsikouras P, Tsitsis V, Vlahos N, Rodolakis A, Papageorghiou A, Loutradis D. ENhancinG vAGinal dElivery in Greece through educational and behavioral interventions among maternity care providers regarding labor management: the ENGAGE stepped-wedge randomized prospective trial protocol. Trials. 2024 Aug 19;25(1):548. doi: 10.1186/s13063-024-08263-x.
- Trial webpageLink provided by the sponsor.
- Individual participant dataSharing planned: No. Study data may be shared upon chief investigator's decision after reasonable request and up to 8 year after the conclusion of the trial.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nikolaos Vrachnis, Prof Ob/Gyn principal investigator
Hellenic Society of Obstetrics and Gynecology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HSOG guidelines application, Interactive workshops and courses and Feedback through follow-up meetings in people with Cesarean Section Rates, run by Hellenic Society of Obstetrics and Gynecology at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cesarean section rate (time frame: Admission to maternity unit to time of vaginal or cesarean birth). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04504500, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2024; AzTrials last refreshed its copy on 6 Nov 2026.