ENchancinG vAGinal dElivery

- There is an emerging need to systematically investigate the causes for the increased cesarean section rates in Greece and undertake interventions so as to substantially reduce its rates

- The ability of the participating Greek obstetricians to follow evidence-based guidelines and respond to other educational and behavioral interventions while managing labor will be explored, along with barriers and enablers

- Twenty-two (22) selected maternity units in Greece will participate in a multicenter stepped-wedge randomized prospective trial with two of them entering the intervention period of the study each month (stepped randomization)

About ENGAGE trial

The Protocol of the Trial

There is an emerging need to systematically investigate the increased cesarean section (CS) rates in Greece and develop interventions to substantially reduce them. This involves the need for Greek obstetricians to follow evidence-based guidelines and other educational, behavioral and organizational interventions, while managing labor. Herein discussed is the planned implementation of a stepped-wedge trial in Greek maternity units. Twenty-two maternity units in Greece will participate in a multicentre stepped-wedge randomized trial involving 20.000 to 25.000 births, with two of them entering the intervention period each month (stepped randomization). Following a 3-13 month baseline phase, the maternity units will apply the interventions for a period of 6-16 months, depending on the time they are randomized to enter the intervention stage of the study. Study interventions will include implementation of Hellenic Society of Obstetrics and Gynecology (HSOG) guidelines on labor management and targeted training on cardiotocography, obstetric emergencies and the Robson criteria. During the intervention study period, the rates and indications for cesarean sections will be available on a live platform to participating units. During this phase, participating obstetricians will be able to see their and other units’ performance and also get feedback on their rates. Τhe final three-month phase of the study will be dedicated to completing follow-up questionnaires. The primary outcome assessed will be the change in cesarean section rate. Secondary outcomes include maternal and neonatal morbidity and mortality. Intervention and control periods will be compared using mixed effects logistic regression with adjustment for any underlying secular trends. The study is expected to yield new information about interventions to reduce unnecessary cesarean sections in Greece. The results will inform efforts to improve the quality of maternal and neonatal care, particularly to reduce high CS rates in Greece.

Trial registration: The trial was prospectively registered to ClinicalTrials.gov: NCT04504500

Trial ID: NCT04504500 (http://clinicaltrials.gov/show/NCT04504500) ClinicalTrials.gov

Ethics Reference No: Bioethics and Conduct Committee, School of Medicine, National and Kapodistrian University of Athens, Greece, Ref No 320/23.6.2020

Funding Bodies: National and Kapodistrian University of Athens, GR / A. G. Leventis Foundation, UK / St George’s University of London, UK

Purpose of this website: This website has been developed for the participating obstetricians and staff to access the guidelines and download evidence-based information (plus other information, e.g., Robson criteria for cesarean sections). 

Trial Sponsor: Hellenic Society of Obstetrics and Gynecology (HSOG)

Download the Protocol

Timeline

  • 2014: The Hellenic Society of Obstetrics and Gynecology (HSOG) published a position statement expressing concerns on the high cesarean section rates in Greece
  • 2018: During the 14th annual congress of HSOG, the board of the society decided to schedule a prospective trial in order to enhance vaginal delivery in Greece. The name of the trial was ENGAGE.
  • 01/06/2021: The ENGAGE began the first randomized prospective trial in Greece with 22 participating units from public (National Health System (NHS) and university) and private maternity units. Simultaneously all maternity units began recording their routine activity for at least 8 months. Following the observation period, the intervention period of the trial lasted 8-18 months. Each month two of the participating units entered randomly into the intervention period.
  • 23/02/2022: Iaso private maternity unit flipped into the intervention period.
  • 28/02/2022: Patras public university unit flipped into the intervention period.
  • 21/03/2022: Chatzikosta public NHS unit flipped into the intervention period.
  • 22/03/2022: Eleftho private maternity unit flipped into the intervention period.
  • 18/04/2022: Diavalkaniko private maternity unit flipped into the intervention period.
  • 19/04/2022: Alexandroupolis public university unit flipped into the intervention period.
  • 16/05/2022: Alexandra public university unit flipped into the intervention period.
  • 17/05/2022: Larisa public university unit flipped into the intervention period.
  • 21/06/2022: Ioannina public university unit flipped into the intervention period.
  • 24/06/2022: Agios Nikolaos public NHS unit flipped into the intervention period.
  • 12/07/2022: Heraklion public university unit flipped into the intervention period.
  • 12/07/2022: Venizeleio public NHS unit flipped into the intervention period.
  • 30/08/2022: Tzaneio public NHS unit flipped into the intervention period.
  • 31/08/2022: Attikon public university unit flipped into the intervention period.
  • 05/09/2022: Aretaieion public university unit flipped into the intervention period.
  • 06/09/2022: Corinthos public NHS unit flipped into the intervention period.
  • 03/10/2022: Viokliniki private maternity unit flipped into the intervention period.
  • 04/10/2022: Ippokrateio 2nd department public university unit flipped into the intervention period.
  • 26/10/2022: Ippokrateio 3rd department public university unit flipped into the intervention period.
  • 27/10/2022: Papageorgiou public university unit flipped into the intervention period.
  • 28/11/2022: Mitera private maternity unit flipped into the intervention period.
  • 29/11/2022: Pyrgos public NHS unit flipped into the intervention period.
  • 10/08/2023: The Engage successfully ended. No new cases were entered.
  • 10/09/2023: The REDcap platform was finally closed allowing the participating units to enter any remaining data.
  • 15/04/2024: The statistical analysis of the data was finished.
  • 15/06/2024: The results of the trial were presented at the 16th National Congress of Obstetrics and Gynecology by the Principal Investigator Professor Nikolaos Vrachnis.

This is our

Team

Steering Committee (Provides oversight and supervision of the conduct of the trial on behalf of the PI and the Sponsor):

  • Professor Dimitrios Loutradis (Chair), Alexandra University Hospital
  • Professor Nikolaos Vrachnis (Principal Investigator), Attikon University Hospital
  • Professor Aris Papageorgiou, St George’s University Hospital
  • Professor Peter Von Dadelszen, King’s College London
  • Professor Laura Magee, King’s College London
  • Marianne Vidler, University of British Columbia
  • Jeffrey Bone, University of British Columbia
  • Professor Apostolos Athanasiadis, Ippokrateio University Hospital
  • Dr Christodoulos Akrivis, Chatzikosta Hospital
  • Professor Aris Antsaklis, Iaso Hospital
  • Professor Georgios Adonakis, Patras University Hospital
  • Professor Nikolaos Vlahos, Aretaieio University Hospital
  • Professor Grigorios Grimbizis, Papageorgiou University Hospital
  • Ass. Professor Aggelos Danilidis, Ippokrateio University Hospital
  • Professor Alexandros Daponte, Larisa University Hospital
  • Professor Peter Drakakis, Attikon University Hospital
  • Professor Sophia Kalantaridou, Attikon University Hospital
  • Dr Vasileios Sioulas, Mitera Hospital
  • Dr Nikolaos Kambas, Corinthos Hospital
  • Dr Theodoros Katasos, Agios Nikolaos Hospital
  • Professor Michail Mataliotakis, Venizeleio Hospital
  • Professor Antonios Makrigiannakis, Heraklion University Hospital
  • Dr Ilias Katsikis, Viokliniki Hospital
  • Professor Nikolaos Nikolettos, Alexandroupolis University Hospital
  • Professor Georgios Pados, Diavalkanikon Hospital
  • Professor Minas Paschopoulos, Ioannina University Hospital
  • Dr Konstantinos Patsouras, Tzaneio Hospital
  • Dr Meni Saklamaki, Mitera Hospital
  • Professor Soultana Siahanidou, Agia Sophia Children’s Hospital
  • Dr Vasilios Tsitsis, Pyrgos Hospital

Executive Committee (Concentrates on the progress of the study, adherence to the protocol and consideration of new information relevant to the research question):

  • Professor Nikolaos Vrachnis (Chair) (Principal Investigator), Attikon University Hospital
  • Professor Dimitrios Loutradis, Alexandra University Hospital
  • Professor Aris Papageorgiou, St George’s University Hospital
  • Professor Peter Von Dadelszen, University of British Columbia
  • Professor Efthimios Deligeoroglou, University of Athens Medical School
  • Professor Peter Drakakis, Attikon University Hospital 
  • Professor Nikoletta Iakovidou, Aretaieio University Hospital
  • Professor Laura Magee, King’s College London
  • Professor Alexandros Rodolakis, Alexandra University Hospital
  • Professor Marleen Temmerman, Aga Khan University Hospital
  • Marianne Vidler, University of British Columbia

Data Safety Committee (Responsible for scientific and ethical review of the Trial prior to its initiation and monitoring to ensure ethical compliance during the conduct of the Trial):

  • Anna Pilar Betran Lazaga, WHO Department of Reproductive Health and Research
  • Professor Stamatina Illiodromiti, Queen Mary Hospital
  • Professor Evangelia Samoli, University of Athens Medical School 

Budget and Finance Committee (Negotiates, analyzes, recommends, and regularly reviews the financial components of the clinical trial, in collaboration with the Trial’s sponsor):

  • Professor Dimitrios ­ Loutradis (Chair), Alexandra University Hospital
  • Professor Nikos Vrachnis (Principal Investigator), Attikon University Hospital
  • Professor Georgios Adonakis, Patras University Hospital
  • Dr Emmanouil Doulgerakis
  • Dr Alexander Mortakis
  • Dr Paraskevas Petropoulos
  • Professor Nikolaos ­ Vlahos, Aretaieio University Hospital

Data Monitoring Committee (Clinicians and biostatisticians appointed to provide assessment of the scientific validity and integrity of clinical trials. Practical aspects on the progress of the study, adherence to the protocol, data acquisition and storage, solving technical issues when arise):

  • Ass. Professor Nikolaos Antonakopoulos (Chair), Patras University Hospital
  • Dr George Maroudias
  • Dr Nikolaos Loukas, Tzaneio Hospital
  • Dr Nikolaos Roussos
  • Dr Stefania Kassaris
  • Jeffrey Bone, University of British Columbia
  • Marianne Vidler, University of British Columbia
  • Sandu Ash, University of British Columbia

A Few

News

16th National Congress of Obstetrics and Gynecology, 13-16 June 2024, Ioannina

Lecture: Cesarean section and Greek reality, 15/06/2024

Speaker: Professor Nikolaos Vrachnis, Attikon University Hospital, Principal Investigator of ENGAGE trial

 

30th Annual Special Joint of Hellenic Society of Obstetricians and Gynecologists, 16-18 June 2023, Patra

Lecture: Early results of ENGAGE trial, 17/06/2023

Speaker: Professor Nikolaos Vrachnis, Attikon University Hospital, Principal Investigator of ENGAGE trial

Contact us

Trial Sponsor: Hellenic Society of Obstetrics & Gynecology, HSOG (https://hsog.gr)

Principal Investigator: Professor Nikolaos Vrachnis, Attikon University Hospital

Adress: Vasillisis Sofias avenue 124B, PC 11526, Greece

Telephone:  +306973796056 +30 2107789211

What’s up call: +306973796056

Email: nvrachnis@med.uoa.gr

Sponsor

Hellenic Society of Obstetrics and Gynecology

Supporting Organisations