Implementation of guidelines about women with previous cesarean section through educational/motivational interventions

Abstract Objective To investigate the effect of a quality improvement project with an educational/motivational intervention in northern Italy on the implementation of the trial of labor after cesarean section (CS). Method A pre‐post study design was used. Every birth center (n = 23) of the Emilia‐Romagna region was included. Gynecologist opinion leaders were first trained about Italian CS recommendations. Barriers to implementation were discussed and shared. Educational/motivational interventions were implemented. Data of multipara with previous CS, with a single, cephalic pregnancy at term, were collected during two periods, before (2012–2014) and after (2017–2019) the intervention (2015–2016). The primary outcome was the rate of vaginal birth after CS (VBAC) and perinatal outcomes. Results A total of 20 496 women were included. The VBAC rate increased from 18.1% to 23.1% after intervention (P < 0.001). The likelihood of VBAC—adjusted for age 40 years or older, Caucasian, body mass index (BMI, calculated as weight in kilograms divided by the square of height in meters) at least 30, previous vaginal delivery, and labor induction—was increased by the intervention by 42% (odds ratio 1.42, 95% confidence interval 1.31–1.54). Neonatal well‐being was improved by intervention; neonates requiring resuscitation decreased from 2.1% to 1.6% (P = 0.001). Conclusion Educating and motivating gynecologists toward the trial of labor after CS is worth pursuing. Health quality improvement is demonstrated by increased VBAC even improving neonatal well‐being.


| INTRODUC TI ON
Cesarean section (CS) is an effective and life-saving obstetric intervention in the presence of conditions complicating pregnancy or labor. However, it is associated with both immediate and long-term maternal and perinatal risks. 1,2 Rates of CS have been increasing everywhere in the past decades, 3 becoming a pervasive phenomenon.
This constant rise 4 is a public health concern in developed countries despite large variation among them. 5 Major factors contributing to the increase in CS rates include primary CS, the increase of labor inductions, and the decrease in vaginal birth after CS (VBAC).
Elective repeat CS (RCS) and VBAC for women with a previous CS are both associated with benefits and harms. 6 Most studies report an increase in adverse maternal and neonatal outcomes following RCS. 7,8 Hence, the approach of the trial of labor after CS (TOLAC) provides the opportunity to achieve a VBAC for women with a history of one or two previous low-transverse incisions, in the absence of further risk factors. 9 This advice was promoted by several organizations including the American College of Obstetricians and Gynecologists in 2010, 10 the National Institute for Health and Care Excellence in 2013, 11 and the Italian Superior Health Institute, which released guidelines in 2012. 12 Despite the evidence of safety and feasibility of TOLAC and the recognized health benefits of vaginal birth, the average rate of VBAC in Italy did not change, remaining lower than 10% 13 in recent years.
As Italy has one of the highest CS rates (31.1%) in Europe, 14 and considering that northern European countries (Sweden, Finland) have reached a 45%-55% VBAC rate, there is an urgent need to develop and evaluate multifaceted prenatal and perinatal interventions to effectively reduce the number of unnecessary CS in Italy, also promoting VBAC where appropriate. 12,15 Few studies have evaluated the effects of clinician-centered interventions to promote VBAC, and the available data show conflicting results. 16,17 A systematic review on this topic reported that the only strategy that significantly increased VBAC rates was an educational intervention provided by an opinion leader. 15 Moreover, interventions such as audit feedback, quality improvement, and multifaceted strategies are effective ways to change clinical practice and reduce the rate of CS. 18 Finally, a recent multicenter cluster trial-the QUARISMA trial-involving more than 180 000 participants showed that a multifaceted intervention reduced the risk of CS in low-risk pregnancies. 19 On these bases, we decided to perform an area-based quality improvement program focusing on the implementation of Italian guidelines related to VBAC in Emilia-Romagna, a north Italian region, characterized by a proactive policy of health quality.

| Study population
The present pre-post study is part of a project endorsed by the Regional Health Authority of Emilia-Romagna, a regional governmental body accountable for issuing routinely collected anonymized patient data to research institutions. Institutional Review Board or Ethics Committee approval was not needed because, according to the Italian privacy law (Legislative Decree 101/2018, D. Lgs 101/2018), regional National Health Service data can be used for scientific purposes provided sensitive information is anonymized.
Emilia-Romagna is a region of central Italy that accounts for about 30 000 deliveries/year occurring in 23 public birth centers.
Data about birth certificates have been issued annually since 2003 and analyzed in a public report. 20 The study included every woman categorized in Robson Class V 21 who delivered in Emilia-Romagna in the period 2012-2019.

| Intervention
Gynecologist opinion leaders were first trained in Italian National Health Service recommendations on the appropriate use of CS, counseling on VBAC, and knowledge of Grobman score. The gynecologist opinion leader was the most experienced as well as the most motivated physician with attitudes in counseling on the mode of delivery.
The training was performed for one opinion leader for each birth unit.
Barriers to implementation and possible solutions were discussed locally and shared at the regional level. The educational/motivational According to the Grobman nomogram, the main outcome was adjusted for known maternal conditions affecting VBAC success, i.e., previous vaginal delivery, pre-pregnancy body mass index (BMI; calculated as weight in kilograms divided by the square of height in meters) classes, maternal age 40 years or older, maternal education level, and place of origin (Italian or foreign). Educational/motivational VBAC intervention was also included. Relevant perinatal outcomes were collected.

| Data sources
Data from the 23 maternity services of Emilia-Romagna during calendar years 2012-2014 and 2017-2019 were extracted from the Emilia-Romagna Birth Certificates (CedAP is the Italian acronym), including the mother's sociodemographic information (maternal age, education, place of origin, smoking, occupation, BMI), obstetric history (previous delivery, vaginal delivery and assisted reproductive technologies), clinical information on the current pregnancy (antenatal course, mode of labor and delivery, gestational age at birth), and the newborn (birth weight, stillbirth, Apgar score < 7, need for resuscitation) collected within 10 days of delivery by the attending midwife of all Maternity units.

| Statistical methods
Analyses were set up by comparing the two study groups "before" and "after" the educational/motivational intervention. Student t test and χ 2 test were performed for continuous and categorical variables, respectively. Continuous variables were described as the mean ± standard deviation (SD), whereas categorical variables were described as the absolute and percentage frequencies. The multivariable prediction model for the risk of having an RCS was developed by carrying out the following steps. First, univariate logistic regression models were used to assess the relationship among each relevant independent variable. The final prediction model was determined by a stepwise backward selection procedure in which only independent variables associated with RCS risk with P value less than 0.05 were retained. Results of logistic models were reported as the odds ratio (OR) with 95% confidence interval (CI) and Wald P value. Statistical analyses were performed with Stata 16.1 (StataCorp. 2019).

| RE SULTS
During the study period a total of 269 497 women delivered in The characteristics of the population are reported in Table 1, divided between the pre-intervention and post-intervention groups. Compared with the pre-intervention group, the post-intervention group presented an overall significant reduction in RCS rate (Preintervention 9043, 81.9% vs. Post-intervention 7278, 76.9%; P < 0.001), corresponding to a 5.0% reduction ( Table 2). Indeed, we found that the rate of elective CS was significantly lower, whereas the rate of induction of labor in the post-intervention group was higher (Pre-intervention 3.3% vs. Post-intervention 6.4%; P < 0.001), indicating different management of women with previous CS in the latter group, accompanied by a significantly higher rate of women delivering between 39 and 41 weeks of pregnancy (P = 0.001).
Table S1 in the supplementary material shows the different distribution of VBAC pre-and post-intervention across the 23 hospitals that participated in the study.
The results of the multivariable analyses are reported in Table 5.

| DISCUSS ION
The educational motivational intervention implemented for 2 years in our region allowed an overall increase in VBAC rate of around 5%, although with heterogeneity among birth centers.
Such an effect has been obtained with a multidisciplinary program, including audits regarding the indications for CS, feedback to health professionals, and implementation of best practices.
Few studies have evaluated similar programs. A systematic review evaluated the effects of clinician-centered interventions. 15 Three studies were included, one of them evaluating a leader educational strategy, which has shown benefits for increasing VBAC rates. However, all those studies were performed before 1996. In contrast, recent studies demonstrated that neither the use of decision aids nor the education of women has a significant effect on VBAC rates. 22  promote VBAC where appropriate. All eligible women should be offered the option of TOLAC as a standard policy, especially in centers equipped with an anesthesiology unit dedicated to the labor ward, a blood bank, and an interventional radiology unit. These supports allow clinicians appropriate management of the dramatic, though rare, emergencies of uterine rupture. Although this intervention approach seems to be effective, further research to improve the best way of promoting VBAC is essential.
In conclusion, educating and motivating gynecologists toward TOLAC is worth pursuing. Health quality improvement is demonstrated by increased VBAC, even improving neonatal well-being.

ACK N OWLED G M ENTS
Open Access Funding provided by Universita degli Studi di Modena e Reggio Emilia within the CRUI-CARE Agreement.
[Correction added on 08-May-2022, after first online publication: CRUI-CARE funding statement has been added.]

CO N FLI C T S O F I NTE R E S T
The authors have no conflict of interests.  Abbreviations: BMI, body mass index (calculated as weight in kilograms divided by the square of height in meters); CI, confidence interval; OR, odds ratio; VBAC, vaginal birth after cesarean section.