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

Официальное название

Planned Delivery at 37 Versus 36 Weeks in Pregnancies Complicated byPlacenta Previa and Accreta: A Randomized Controlled Trial

Обзор

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.

Подробное описание

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.

Вмешательства

• Процедура 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 conse

Первичные конечные точки

• Composite neonatal morbidity [Срок оценки: Within 30 days after childbirth]
• Intraoperative Estimated Blood Loss (EBL) [Срок оценки: From surgery initiation to 24 hours postoperatively]

Вторичные конечные точки (3)

• Incidence of unplanned cesarean delivery [Срок оценки: Immediately after procedure]
• Rate of Hysterectomy [Срок оценки: Within 30 days after childbirth]
• Perioperative RBC transfusion (U) [Срок оценки: Perioperatively]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 6 центров

• The Third Affiliated Hospital of Guangzhou Medical University — Гуанчжоу
• The First Affiliated Hospital of Zhengzhou University — Чжэнчжоу
• West China Second University Hospital, Sichuan University — Чэнду
• Peking University Third Hospital — Пекин
• The First Affiliated Hospital of Chongqing Medical University — Чунцин
• Guangzhou Women and Children's Medical Center — Гуанчжоу

Идентификаторы

NCT: NCT07025954 · IRB(2025)-061

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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