Actively Recruiting
Planned Delivery at 37 Versus 36 Weeks in Pregnancies Complicated by Placenta Previa and Accreta: A Randomized Controlled Trial
Led by The Third Affiliated Hospital of Guangzhou Medical University · Updated on 2025-07-16
600
Participants Needed
6
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the best timing for planned cesarean delivery in pregnant women with placenta previa and placenta accreta spectrum. The study compares delivery at 37 weeks of gestation versus 36 weeks to see if waiting until 37 weeks improves newborn outcomes without increasing risks to the mother. This randomized controlled trial aims to provide clearer guidance on balancing early birth risks with maternal complications like severe bleeding. Participants are randomly assigned between 28 and 34 weeks of pregnancy to one of two groups: planned delivery at 37 weeks or planned delivery at 36 weeks. All patients undergo cesarean delivery with standardized care including preoperative preparations such as blood reserve and corticosteroids for fetal lung maturity. Conservative management to preserve the uterus is prioritized, with hysterectomy reserved for extensive invasion or failed treatment. During the study, researchers will monitor maternal and newborn health outcomes such as neonatal complications within 30 days after birth and estimated blood loss during surgery. Secondary measures include rates of unplanned cesarean delivery, hysterectomy, blood transfusion, intensive care admissions, and postoperative complications. Participant care follows a detailed protocol, and data analysis will compare safety and effectiveness of delivery timing. The study is expected to run until March 2027.
CONDITIONS
Brief Title
Planned Delivery at 37 Versus 36 Weeks in Pregnancies With Placenta Previaand Accreta
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pregnant women between 28 and 34 weeks of gestation
- Ultrasound and MRI confirm placenta previa with placenta accreta spectrum
- Planning to undergo cesarean delivery at the participating study hospitals
- Agree to participate and sign the informed consent form
You will not qualify if you...
- Multiple gestation pregnancies
- Other obstetric complications such as preeclampsia or vasa previa
- Severe maternal medical conditions like uncontrolled diabetes, progressive cardiovascular disease, active systemic lupus erythematosus, or liver cirrhosis
- Major uterine structural anomalies including uterine didelphys or uterine tumors larger than 5 cm
- Estimated fetal weight below the 3rd percentile for gestational age, major congenital anomalies, or intrauterine fetal demise
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - From 36 to 37 weeks of gestation until hospital discharge
Participants undergo planned cesarean delivery either at 36 or 37 weeks of gestation with standardized perioperative management including preparation, surgery, and postoperative care.
1 surgical procedure and hospital stay
Duration - Up to 30 days after childbirth
Participants are monitored for recovery and outcomes including maternal and neonatal health during the 30 days following childbirth.
Approximately 1 to 2 visits depending on recovery
Trial Site Locations
Total: 6 locations
1
The Third Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China, 510150
Actively Recruiting
2
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China, 450001
Not Yet Recruiting
3
West China Second University Hospital, Sichuan University
Chengdu, Sichuan, China, 610041
Not Yet Recruiting
4
Peking University Third Hospital
Beijing, China
Not Yet Recruiting
5
The First Affiliated Hospital of Chongqing Medical University
Chongqing, China
Not Yet Recruiting
6
Guangzhou Women and Children's Medical Center
Guangzhou, China
Not Yet Recruiting
Research Team
Q
Qingwen Nie
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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