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

NCT07025954 | Recruiting

• 1 other identifier: IRB(2025)-061
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 6

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• Composite neonatal morbidity

  The Composite neonatal morbidity was defined as any of the following: admission to the Neonatal Intensive Care Unit (NICU), need for mechanical ventilation (MV), Respiratory Distress Syndrome (RDS), Transient Tachypnea of Newborn (TTN), Necrotizing Enterocolitis (Necrotizing Enterocolitis), and necrotizing Enterocolitis (NEC). Syndrome (RDS), Transient Tachypnea of Newborn (TTN), Necrotizing Enterocolitis (NEC), Intraventricular Hemorrhage (IVH), Septicemia (S), and Necrotizing Enterocolitis (NE). IVH), sepsis (Sepsis), and neonatal death. Evaluator blinding was used to ensure the objectivity of the assessment, and the pediatrician responsible for assessing neonatal complications was unaware of the grouping information.

  Within 30 days after childbirth

• Intraoperative Estimated Blood Loss (EBL)

  Intraoperative EBL was calculated during delivery using a combined gravimetric and volumetric method: all surgical gauzes and drapes were weighed before the procedure (preoperative weight), and blood-soaked gauzes and drapes were weighed postoperatively (postoperative weight); the baseline fluid volume in the suction canister was recorded before amniotic fluid aspiration, and the total volume was recorded immediately after completion of amniotic fluid aspiration (amniotic fluid volume = post-aspiration volume - baseline volume). The final EBL （ml）was calculated as: (postoperative weight - preoperative weight) + (total suctioned volume - amniotic fluid volume - irrigation fluid volume).

  From surgery initiation to 24 hours postoperatively

Secondary Outcomes (3)

• Incidence of unplanned cesarean delivery

  Immediately after procedure

• Rate of Hysterectomy

  Within 30 days after childbirth

• Perioperative RBC transfusion (U)

  Perioperatively

Study Arms (2)

37-week group

EXPERIMENTAL

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

Procedure: Cesarean delivery

36-week group

ACTIVE COMPARATOR

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

Procedure: Cesarean delivery

Interventions

Cesarean delivery 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; 37-week group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Third Affiliated Hospital of Guangzhou Medical University: lead

Study Sites (6)

The Third Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510150, China

RECRUITING

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450001, China

NOT YET RECRUITING

West China Second University Hospital, Sichuan University

Chengdu, Sichuan, 610041, China

NOT YET RECRUITING

Peking University Third Hospital

Beijing, China

NOT YET RECRUITING

The First Affiliated Hospital of Chongqing Medical University

Chongqing, China

NOT YET RECRUITING

Guangzhou Women and Children's Medical Center

Guangzhou, China

NOT YET RECRUITING

MeSH Terms

Conditions

Placenta Previa; Placenta Accreta

Interventions

Cesarean Section

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Placenta Diseases

Intervention Hierarchy (Ancestors)

Delivery, Obstetric; Obstetric Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Zhijian Wang, MD, PhD

  The Third Affiliated Hospital of Guangzhou Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Qingwen Nie

CONTACT

+86 15622149953; nieqingwen@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, MD, PhD

Study Record Dates

• First Submitted: May 21, 2025
• First Posted: June 18, 2025
• Study Start: July 12, 2025
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: July 16, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (6)