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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-12

Study Completion Date

2027-03-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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37-week group

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

Group Type EXPERIMENTAL

Cesarean delivery

Intervention Type PROCEDURE

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 conservative treatment.

36-week group

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

Group Type ACTIVE_COMPARATOR

Cesarean delivery

Intervention Type PROCEDURE

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 conservative treatment.

Interventions

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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 conservative treatment.

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Responsible Party

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wangzhijian

Professor, MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Zhijian Wang, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

The Third Affiliated Hospital of Guangzhou Medical University

Locations

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The Third Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

Site Status RECRUITING