Planned cesarean at 37 weeks versus 36 weeks for pregnancies with placenta previa and accreta

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

We will test whether scheduling cesarean delivery at 37 weeks instead of 36 weeks helps newborns without increasing maternal bleeding in pregnant women with placenta previa and accreta.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 600 (estimated)
• Ages: 18 Years to 45 Years
• Sex: Female
• Sponsor: The Third Affiliated Hospital of Guangzhou Medical University (Academic / other)
• Locations: 6 sites (Guangzhou, Guangdong and 5 other locations)
• Trial ID: NCT07025954 on ClinicalTrials.gov

What this trial studies

This is a multicenter, prospective, open-label randomized controlled trial enrolling pregnant women with ultrasound- and MRI-confirmed placenta previa and placenta accreta spectrum who are 28–34 weeks gestation and planned for cesarean delivery. Participants are randomized 1:1 by center, with allocation concealed using opaque sealed envelopes and analyses performed primarily by intent-to-treat with statisticians blinded to group codes. The primary efficacy outcome is a composite neonatal morbidity rate and the primary safety outcome is intraoperative estimated blood loss during cesarean delivery, with secondary outcomes including unplanned cesarean, hysterectomy, ICU admission, transfusion units, operative duration, surgical complications, reoperation, postpartum morbidity, and neonatal NICU admission. The trial tests whether delaying planned delivery to 37 weeks reduces neonatal immaturity without raising maternal hemorrhage or surgical risk.

Who should consider this trial

Good fit: Pregnant women at 28–34 weeks with both ultrasound and MRI confirming placenta previa with placenta accreta spectrum who plan cesarean delivery at a participating hospital and consent to the trial are eligible.

Not a fit: Patients with multiple gestation, major obstetric complications (for example preeclampsia or vasa previa), severe maternal medical disease, major uterine anomalies, estimated fetal weight <3rd percentile, major fetal anomalies, or intrauterine fetal demise are excluded and would not be expected to benefit from this protocol.

Why it matters

Potential benefit: If successful, scheduling delivery at 37 weeks could reduce neonatal immaturity and NICU stays while not increasing maternal bleeding or surgical complications.

How similar studies have performed: Retrospective studies and a recent nonrandomized report suggested that shifting planned delivery from 34–36 weeks to 37 weeks did not increase maternal intraoperative or postoperative hemorrhage, but high-quality randomized evidence remains limited.

Eligibility criteria

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.

Where this trial is running

Guangzhou, Guangdong and 5 other locations

• The Third Affiliated Hospital of Guangzhou Medical University — Guangzhou, Guangdong, China (Recruiting)
• The First Affiliated Hospital of Zhengzhou University — Zhengzhou, Henan, China (Not_yet_recruiting)
• West China Second University Hospital, Sichuan University — Chengdu, Sichuan, 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)

Study contacts

• Principal investigator: Zhijian Wang, MD, PhD — The Third Affiliated Hospital of Guangzhou Medical University
• Study coordinator: Qingwen Nie

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