Planned Delivery at 37 Versus 36 Weeks in Pregnancies With Placenta Previaand Accreta

Condition(s) studied

Investigational drug(s) / intervention(s)

Cesarean delivery: All 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.

Study summary

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

Primary outcome measure(s)

• Composite neonatal morbidity — Within 30 days after childbirth
  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) — From surgery initiation to 24 hours postoperatively
  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).

Trial sites (6)

More The Third Affiliated Hospital of Guangzhou Medical University trials in China

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