Clinical trial NCT07025954: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Placenta Previa
Placenta Accreta Spectrum
Antepartum Bleeding
Emergency Cesarean Section
Preterm Birth Complication
Lead sponsor: The Third Affiliated Hospital of Guangzhou Medical University
Sponsor class: OTHER
First posted: 2025-06-18
Enrollment: 600
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

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.

Primary outcomes:
measure: Composite neonatal morbidity
timeFrame: Within 30 days after childbirth
measure: Intraoperative Estimated Blood Loss (EBL)
timeFrame: From surgery initiation to 24 hours postoperatively
Secondary outcomes:
measure: Incidence of unplanned cesarean delivery
timeFrame: Immediately after procedure
measure: Rate of Hysterectomy
timeFrame: Within 30 days after childbirth
measure: Perioperative RBC transfusion (U)
timeFrame: Perioperatively
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The Third Affiliated Hospital of Guangzhou Medical University
state: Guangdong
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University
state: Henan
city: Chengdu
country: China
facility: West China Second University Hospital, Sichuan University
state: Sichuan
city: Beijing
country: China
facility: Peking University Third Hospital
city: Chongqing
country: China
facility: The First Affiliated Hospital of Chongqing Medical University
city: Guangzhou
country: China
facility: Guangzhou Women and Children's Medical Center
Study officials:
affiliation: The Third Affiliated Hospital of Guangzhou Medical University
name: Zhijian Wang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: