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

The Third Affiliated Hospital of Guangzhou Medical University

Status: Enrolling

Conditions: Preterm Birth Complication; Emergency Cesarean Section; Placenta Previa; Antepartum Bleeding; Placenta Accreta Spectrum

Treatments: Procedure: Cesarean delivery

Study type: Interventional

Funder types: Other

Identifiers

NCT07025954

IRB(2025)-061

Details and patient eligibility

About

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.

Full 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.

Enrollment: 600 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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600 participants in 2 patient groups

37-week group

Experimental group

Description:

Subjects were randomized 1:1 at 28-34 weeks. 37-week group: planned delivery at 37 0/7-37 6/7 weeksof gestation.

Treatment:

Procedure: Cesarean delivery

36-week group

Active Comparator group

Description:

Subjects were randomized 1:1 at 28-34 weeks. 36-week group: planned delivery at 36 0/7-36 6/7 weeksof gestation.

Treatment:

Procedure: Cesarean delivery