Planned Delivery at 37 Versus 36 Weeks in Pregnancies Complicated byPlacenta Previa and Accreta: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 600
- 试验地点
- 9
- 主要终点
- Composite neonatal morbidity
研究概览
简要总结
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.
详细描述
This is a multicenter, prospective, open-label, randomized controlled trial, which aims to determine the optimal delivery timing for pregnant women with placenta previa and accreta. Participants were stratified by centers and randomly assigned in 1:1 at 28-34 weeks of gestation. Opaque sealed envelopes used to mask randomization sequences. The primary efficacy outcome is the composite neonatal morbidity rate, while the primary safety outcome is intraoperative estimated blood loss (EBL) during cesarean delivery. Secondary outcomes include the incidence of unplanned cesarean delivery, hysterectomy rate, maternal ICU admission, total packed red blood cell transfusion (units), operative duration (hours), surgical complications, unplanned reoperation rate, postpartum morbidity, and neonatal NICU admission. Statistical analyses will be performed based on the intent-to-treat (ITT) principle using the full analysis set (FAS), with a supportive per-protocol (PP) analysis. The statisticians will remain blinded to group assignments through coded data until the final analysis is completed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Composite neonatal morbidity
时间窗: 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)
时间窗: 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).
次要结局
- Incidence of unplanned cesarean delivery(Immediately after procedure)
- Rate of Hysterectomy(Within 30 days after childbirth)
- Perioperative RBC transfusion (U)(Perioperatively)
研究者
wangzhijian
Professor, MD, PhD
The Third Affiliated Hospital of Guangzhou Medical University