RESUMEN
BACKGROUND: Placenta accreta spectrum is a serious condition associated with significant maternal morbidity and even mortality. The recommended treatment is hysterectomy. An alternative is 1-step conservative surgery, which involves the en bloc resection of the myometrium affected by placenta accreta spectrum along with the placenta, followed by uterine reconstruction. Currently, there are no studies comparing the 2 techniques in the setting of a randomized controlled trial. OBJECTIVE: We performed a prospectively registered multicenter randomized controlled trial comparing hysterectomy with 1-step conservative surgery. The aim was to collect feasibility and clinical outcomes of the 2 techniques in women assigned to hysterectomy or 1-step conservative surgery. In addition to assessing participants' willingness to be randomized, we also collected data on intraoperative blood loss, transfusion requirement, serious adverse event, and other clinical outcomes. STUDY DESIGN: Sixty women with strong antenatal suspicion of placenta accreta spectrum were assigned randomly to either hysterectomy (n=31) or 1-step conservative surgery (n=29). RESULTS: During a 20-month period, 60 of the 64 eligible patients (93.7%) underwent randomization. Intention-to-treat analysis showed that the clinical outcomes for 1-step conservative surgery were comparable to those of hysterectomy (median intraoperative blood loss, 1740 mL [interquartile range, 1010-2410] vs 1500 mL [interquartile range, 1122-2753]; odds ratio, 1 [1-1]; P=.942; median duration of surgery, 135 minutes [interquartile range, 111-180] vs 155 minutes [interquartile range, 120-185]; odds ratio, 0.99 [0.98-1]; P=.151; transfusion rate, 58.6% vs 61.3%; odds ratio, 0.96 [0.83-1.76]; P=.768; and adverse event rate, 17.2% vs 9.7%; odds ratio, 1.77 [0.43-10.19]; P=.398; respectively). In the subgroup of women with type 1 class on topographic classification, all participants allocated to 1-step surgery had successful outcomes, which were superior to those of hysterectomy. This was evidenced by the shorter surgery duration (median, 125 [interquartile range, 98-128] vs 180 [129-226] minutes; P=.002), lower transfusion rates (46.2% vs 82.4%), and fewer units of red blood cells transfused (median, 1 [interquartile range, 1-1.8] vs 3 [interquartile range, 2-4] units; P=.007). CONCLUSION: A randomized controlled trial comparing 2 surgical techniques for the treatment of placenta accreta spectrum is feasible. One-step conservative repair is a valid alternative to hysterectomy in the large majority of cases, but this can only be ascertained following intraoperative surgical staging.
RESUMEN
Background: Reducing maternal mortality ratio (MMR) remains a paramount goal for low- and middle-income countries (LMICs), especially after COVID-19's devastating impact on maternal health indicators. We describe our experience implementing the Hospital Padrino Strategy (HPS), a collaborative model between a high-complexity hospital (Fundación Valle del Lili) and 43 medium- and low-complexity hospitals in one Colombian department (an administrative and territorial division) from 2021 to 2022, to sustain the trend towards reducing MMR. The study aimed to assess the effects of implementing HPS on both hospital performance and maternal health indicators in Valle del Cauca department (VCD). Methods: A mixed-methods study was conducted, comprising two phases. In the first phase, we investigated a cohort of hospitals through prospective follow-up to assess the outcomes of HPS implementation on hospital performance and maternal health indicators in VCD. In the second phase, qualitative data were collected through focus groups with 131 health workers from 33 hospitals to explore the implications of the HPS implementation on healthcare personnel. All data were obtained from records within the HPS implementation and from the Health Secretary of VCD. Findings: Evidence shows that in the context of HPS, 51 workshops involved 980 healthcare workers, covering the entire territory. Substantial improvements were observed in hospital conditions and healthcare personnel's technical competencies when providing obstetric care. Seven hundred eighty-five pregnant women with obstetric or perinatal emergencies received care through telehealth systems, with a progressive increase in technology adoption. Nine percent required Intensive Care Unit (ICU) admission, and none died. The MMR decreased from 78.8 in 2021 to 12.0 cases per 100,000 live births by 2022. Improvements in indicators and conducted training sessions instilled confidence and empowerment among the healthcare teams in the sponsored hospitals, as evidenced in focus groups derived from a sample of 131 healthcare workers from 33 hospitals. Interpretation: Implementing the Hospital Padrino Strategy led to a significant MMR reduction, and consolidated a model of social healthcare innovation replicable in LMICs. Funding: The Hospital Padrino Strategy was funded by the Fundación Valle del Lili and the Health Secretary of Valle del Cauca. Furthermore, this study received funding from a general grant for research from Tecnoquimicas S.A.