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

Official title

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

Overview

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.

Detailed description

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.

Interventions

• Procedure 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

Primary outcome measures

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

Secondary outcome measures (3)

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

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

China · 6 centers

• The Third Affiliated Hospital of Guangzhou Medical University — Guangzhou
• The First Affiliated Hospital of Zhengzhou University — Zhengzhou
• West China Second University Hospital, Sichuan University — Chengdu
• Peking University Third Hospital — Beijing
• The First Affiliated Hospital of Chongqing Medical University — Chongqing
• Guangzhou Women and Children's Medical Center — Guangzhou

Identifiers

NCT: NCT07025954 · IRB(2025)-061

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗