Ignite Creation Date:
2024-05-06 @ 3:02 PM
Last Modification Date:
2024-10-26 @ 1:42 PM
Study NCT ID:
NCT04504500
Status:
COMPLETED
Last Update Posted:
2024-01-23
First Post:
2020-08-05
Brief Title:
Reducing Cesarean Section Rates and Enhancing Vaginal Delivery in Greece a Stepped-Wedge Randomized Controlled Trial
Sponsor:
Hellenic Society of Obstetrics and Gynecology
Organization:
Hellenic Society of Obstetrics and Gynecology
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ENGAGE
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 andor 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 20000 to 25000 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None