About this trial
Current clinical practice guidelines recommend planned cesarean delivery(CD) at 34-37 weeks of gestation in pregnant women with placenta previa and accreta. Preterm birth may lead to neonatal immaturity, while laterCD may increase the risk of severe hemorrhage and surgery complications. Retrospective studies have shown that indicated CD occurs in approximately1/3 of patients before 36 weeks, with the main trigger being antepartum hemorrhage. However, the risk of antepartum hemorrhage is lower after 36 weeks. Recent study showed that delivery shifted from 34-36 weeks to 37 weeks did not increase therisk of maternal intraoperative/postoperative hemorrhage and emergency CD. To further validate this, we propose to conduct a randomized controlled study comparing the effect of planned delivery management strategies at 37 0/7-37 6/7 weeks of gestation with those at 36 0/7-36 6/7 weekson maternal and fetal outcomes. The aim of this study is to explore whether planned delivery up to 37 weeks in pregnant women with placenta previa and accreta improves neonatal outcomes without increasing maternal obstetric risks.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
28-34 weeks of gestation.
Both ultrasound and MRI indicate placenta previa with placenta accreta spectrum (PAS).
Planned to undergo cesarean delivery at the participating study hospitals.
Agree to participate and sign the informed consent form.
Disqualifiers
Multiple gestation.
Other obstetric complications (e.g., preeclampsia, vasa previa), and severe maternal medical conditions (e.g., uncontrolled diabetes, progressive cardiovascular disease, active systemic lupus erythematosus, liver cirrhosis).
Major uterine structural anomalies (e.g., uterine didelphys, Uterine tumors ≥5 cm).
Estimated fetal weight <3rd percentile for gestational age, major congenital anomalies, intrauterine fetal demise.
Trial design
Parallel
Treatments tested in this trial
Cesarean delivery
Procedure/SurgeryAll patients were delivered via cesarean section with standardized perioperative management, including preoperative preparation (e.g., autologous bloodreserve, corticosteroid administration for foetal lungmaturation, etc.), surgical approach, and postoperative care. Conservative management (intentional placental retention in situ with local resection and pelvic devascularization) was primarily employed, while peripartum hysterectomy was reserved for those with extensive invasion or failed conservative treatment.
Treatment groups
Trial outcomes
Primary outcomes
Composite neonatal morbidity
The Composite neonatal morbidity was defined as any of the following: admission to the Neonatal Intensive Care Unit (NICU), need for mechanical ventilation (MV), Respiratory Distress Syndrome (RDS), Transient Tachypnea of Newborn (TTN), Necrotizing Enterocolitis (Necrotizing Enterocolitis), and necrotizing Enterocolitis (NEC). Syndrome (RDS), Transient Tachypnea of Newborn (TTN), Necrotizing Enterocolitis (NEC), Intraventricular Hemorrhage (IVH), Septicemia (S), and Necrotizing Enterocolitis (NE). IVH), sepsis (Sepsis), and neonatal death. Evaluator blinding was used to ensure the objectivity of the assessment, and the pediatrician responsible for assessing neonatal complications was unaware of the grouping information.
Intraoperative Estimated Blood Loss (EBL)
Intraoperative EBL was calculated during delivery using a combined gravimetric and volumetric method: all surgical gauzes and drapes were weighed before the procedure (preoperative weight), and blood-soaked gauzes and drapes were weighed postoperatively (postoperative weight); the baseline fluid volume in the suction canister was recorded before amniotic fluid aspiration, and the total volume was recorded immediately after completion of amniotic fluid aspiration (amniotic fluid volume = post-aspiration volume - baseline volume). The final EBL (ml)was calculated as: (postoperative weight - preoperative weight) + (total suctioned volume - amniotic fluid volume - irrigation fluid volume).
Secondary outcomes
Incidence of unplanned cesarean delivery
Unplanned cesarean delivery refers to all cesarean sections performed prior to the gestational age specified in the study protocol, including indications such as uncontrolled antepartum hemorrhage, preterm labor, fetal distress, and other complications requiring delivery before the designated gestational age.
Rate of Hysterectomy
Hysterectomy refers to total or subtotal hysterectomy performed due to refractory hemorrhage during cesarean delivery or postpartum conservative treatment, excluding hysterectomies performed for conditions such as uterine tumors.
Perioperative RBC transfusion (U)
The cumulative unit of packed RBC transfused during hospitalization for delivery.
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