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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of unplanned cesarean delivery | 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. | Immediately after procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qingwen Nie | Contact | +86 15622149953 | nieqingwen@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Zhijian Wang, MD, PhD | The Third Affiliated Hospital of Guangzhou Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Third Affiliated Hospital of Guangzhou Medical University | Recruiting | Guangzhou | Guangdong | 510150 | China |
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| Rate of Hysterectomy | 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. | Within 30 days after childbirth |
| Perioperative RBC transfusion (U) | The cumulative unit of packed RBC transfused during hospitalization for delivery. | Perioperatively |
| The First Affiliated Hospital of Zhengzhou University | Not yet recruiting | Zhengzhou | Henan | 450001 | China |
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| West China Second University Hospital, Sichuan University | Not yet recruiting | Chengdu | Sichuan | 610041 | China |
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| Peking University Third Hospital | Not yet recruiting | Beijing | China |
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| The First Affiliated Hospital of Chongqing Medical University | Not yet recruiting | Chongqing | China |
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| Guangzhou Women and Children's Medical Center | Not yet recruiting | Guangzhou | China |
|
| ID | Term |
|---|---|
| D010923 | Placenta Previa |
| D010921 | Placenta Accreta |
| ID | Term |
|---|---|
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D010922 | Placenta Diseases |
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| ID | Term |
|---|---|
| D002585 | Cesarean Section |
| ID | Term |
|---|---|
| D036861 | Delivery, Obstetric |
| D013513 | Obstetric Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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