Clinical trial NCT04504500: Reducing Cesarean Section Rates and Enhancing Vaginal Delivery in Greece: a Stepped-Wedge Randomized Controlled Trial
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cesarean Section Rates
Keywords: cesarean section
vaginal delivery
birth
Greece
maternal morbidity
perinatal morbidity
ENGAGE trial
stepped-wedge trial
intervention
guideline
Lead sponsor: Hellenic Society of Obstetrics and Gynecology
Sponsor class: OTHER
Collaborators: name: St George's, University of London
name: A. G. Leventis Foundation
name: National and Kapodistrian University of Athens
First posted: 2020-08-07
Enrollment: 6029
Sex: FEMALE
Minimum age (years): 14
Maximum age (years): 46
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: Cesarean section rate
timeFrame: Admission to maternity unit to time of vaginal or cesarean birth
Secondary outcomes:
measure: Maternal morbidity
timeFrame: During labor and 40 days to 3 months after delivery
measure: Perinatal and neonatal morbidity
timeFrame: During labor and 40 days to 3 months after delivery
Other outcomes:
Locations:
city: Athens
country: Greece
facility: All participating units
Study officials:
affiliation: Hellenic Society of Obstetrics and Gynecology
name: Nikolaos Vrachnis, Prof Ob/Gyn
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Chen 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.
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citation: Hussey 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.
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