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NCT Number: NCT07025954

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

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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Key information

Conditions

Placenta Previa Antepartum Bleeding Emergency Cesarean Section Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Placenta Accreta Placenta Accreta Spectrum Placenta Diseases Pregnancy Complications Preterm Birth Complication Urogenital Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

The Third Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Composite neonatal morbidity

    Time frame: Within 30 days after childbirth

    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.

  2. Intraoperative Estimated Blood Loss (EBL)

    Time frame: From surgery initiation to 24 hours postoperatively

    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).

Secondary outcomes

  1. Incidence of unplanned cesarean delivery

    Time frame: Immediately after procedure

    Unplanned cesarean delivery refers to all cesarean sections performed prior to the gestational age specified in the study protocol, including indications such as uncontrolled antepartum hemorrhage, preterm labor, fetal distress, and other complications requiring delivery before the designated gestational age.

  2. Rate of Hysterectomy

    Time frame: Within 30 days after childbirth

    Hysterectomy refers to total or subtotal hysterectomy performed due to refractory hemorrhage during cesarean delivery or postpartum conservative treatment, excluding hysterectomies performed for conditions such as uterine tumors.

  3. Perioperative RBC transfusion (U)

    Time frame: Perioperatively

    The cumulative unit of packed RBC transfused during hospitalization for delivery.

Study contacts

Contact information is provided by the study sponsor or research team.

Qingwen Nie

CONTACT

[email protected]

+86 15622149953

Sponsors and collaborators

Lead sponsor

The Third Affiliated Hospital of Guangzhou Medical University

Other

Registry information

Official study title

Planned Delivery at 37 Versus 36 Weeks in Pregnancies Complicated byPlacenta Previa and Accreta: A Randomized Controlled Trial

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jun 18, 2025
Registry last updated
Jul 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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