Conservative Management vs Cesarean Hysterectomy for Placenta Accreta

Recruiting at 1 trial location

Overseen By Elizabeth Turner

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of Utah

Disqualifiers: Multiples, Uterine fetal demise, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: Day of delivery

32 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores two methods for managing placenta accreta, a condition where the placenta grows too deeply into the uterine wall. One option is conservative management, where doctors deliver the baby via cesarean section and closely monitor the placenta without immediate removal. The other option is a cesarean hysterectomy, where the baby, placenta, and uterus are removed during delivery. Women who have had a cesarean delivery, have placenta previa (where the placenta covers the cervix), and are suspected of having placenta accreta based on prenatal imaging might be suitable candidates for this trial. The study aims to identify safer and more cost-effective treatments for this serious pregnancy condition. As an unphased trial, it offers participants the chance to contribute to groundbreaking research that could enhance treatment options for future patients.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that for some patients, a conservative approach to managing placenta accreta spectrum (PAS) can be safe. This method involves leaving the placenta in place after the baby is born. Studies suggest that this can lower the risk of serious complications and help maintain fertility. Although risks like possible bleeding exist, careful monitoring can manage these effectively.

Conversely, a cesarean hysterectomy, which removes the uterus and placenta, is a more traditional method. While generally safe, it is a major surgery with its own risks, including a longer recovery period.

Both treatments have been studied and offer options for managing PAS, each with its own benefits and risks. It is important for individuals to consult their healthcare provider to make an informed choice. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores two different approaches to managing Placenta Accreta Spectrum (PAS) during delivery. The traditional treatment involves a cesarean hysterectomy, which is the immediate removal of the uterus to prevent life-threatening bleeding. However, this trial also examines conservative management, which allows the placenta to remain in place while closely monitoring the mother for excessive bleeding. This conservative approach could preserve the uterus, offering the potential for future pregnancies and avoiding major surgery. By comparing these two methods, researchers hope to find a safer and less invasive option for women with PAS.

What evidence suggests that this trial's treatments could be effective for placenta accreta spectrum?

This trial will compare two approaches for managing placenta accreta spectrum (PAS): conservative management and cesarean hysterectomy. Research has shown that conservative management, one of the approaches in this trial, can help preserve a woman's future fertility. Studies have found that this method often results in better surgical outcomes. For instance, patients typically lose less blood and sustain fewer urinary system injuries. Additionally, fewer patients require intensive care unit (ICU) admission after surgery. This approach is primarily recommended in hospitals with extensive experience in treating these cases. ^{1 5 6 7 8}

Who Is on the Research Team?

Brett Einerson, MD

Principal Investigator

University of Utah

Are You a Good Fit for This Trial?

This trial is for pregnant individuals over 18 with a history of cesarean delivery and placenta previa or an anterior low-lying placenta who are suspected of having Placenta Accreta Spectrum (PAS) based on prenatal scans. They should be planning to deliver between weeks 34 and 36. Those typically recommended for hysterectomy due to PAS can join, but not those with fetal demise, low suspicion for PAS, planned delivery before week 24, hospitalized due to bleeding, or carrying multiples.

Inclusion Criteria

I have been advised to undergo a hysterectomy.

Planned delivery between 34w0d and 36w0d gestation

You have had a previous C-section and currently have a condition called placenta previa or a low-lying placenta, which is suspected to be a condition called placenta accreta spectrum based on imaging tests like ultrasound or MRI.

Exclusion Criteria

You have experienced a stillbirth.

Based on the images taken during pregnancy, there is a low suspicion that you have a condition called placenta accreta spectrum (PAS).

Plan to delivery before neonatal viability (<24 weeks gestation)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

20 weeks gestation through day of delivery

Treatment

Participants undergo either conservative management or hysterectomy at the time of cesarean delivery

Day of delivery

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including hemorrhage, transfusion, infection, and re-operation

Up to 6 weeks postpartum

Full postpartum follow-up visit schedule

What Are the Treatments Tested in This Trial?

Interventions

• Cesarean hysterectomy for placenta accreta spectrum (PAS)
• Conservative management for placenta accreta spectrum (PAS)

Trial Overview

The study compares conservative in situ management versus the standard Cesarean hysterectomy in treating Placenta Accreta Spectrum (PAS). It aims to determine if conservative treatment is a safer option that could replace hysterectomy while also gathering data to help patients make informed decisions about their care.

How Is the Trial Designed?

Group I: Conservative Management for Placenta Accreta Spectrum (PAS) Experimental Treatment 1 Intervention

Subjects who are randomized to to conservative management will undergo a cesarean delivery followed by a period of close observation in the operating room for 30-45 minutes to be sure there is no excessive bleeding or risk to keep the placenta inside

Group II: Hysterectomy at time of delivery for Placenta Accreta Spectrum (PAS) Active Control 1 Intervention

Subjects who are randomized to cesarean hysterectomy will undergo a cesarean delivery followed immediately by hysterectomy to remove the placenta and uterus together

Cesarean hysterectomy for placenta accreta spectrum (PAS) is already approved in United States, European Union for the following indications:

Approved in United States as Cesarean hysterectomy for:

• Placenta accreta spectrum disorders

Approved in European Union as Immediate hysterectomy for:

• Placenta accreta spectrum disorders

Who Is Running the Clinical Trial?

University of Utah

Lead Sponsor

Trials

1,169

Recruited

1,623,000+

Published Research Related to This Trial

In a study of 11 patients with placenta accreta spectrum (PAS) managed by leaving the placenta in situ, 55% successfully preserved their uterus, suggesting this approach may be a viable option for selected patients.

Among those who preserved their uterus, 67% went on to have subsequent pregnancies, indicating that this management strategy could allow for fertility preservation while managing PAS effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Leaving the Placenta In Situ in Placenta Accreta Spectrum Disorders: A Single-Center Case Series. Pineles, BL., Coselli, J., Ghorayeb, T., et al.[2022]

A modified uterine preserving surgical technique for managing placenta accreta spectrum (PAS) was successfully implemented in 20 patients, preserving the uterus in 90% of cases, which is a significant advantage over traditional Caesarean hysterectomy.

The procedure demonstrated a mean blood loss of 1305 CC and a mean operative time of 123 minutes, with minimal complications, indicating it is a safe option for conservative management of PAS, especially in resource-limited settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Kasr Alainy simplified uterine preserving surgery for conservative management of placenta accreta spectrum (PAS): A modified surgical approach. Mousa, A., Elkhateb, IT., Gaafar, HM., et al.[2023]

In a study of 115 pregnancies complicated by placenta accreta spectrum, using neuraxial anesthesia during late-preterm cesarean hysterectomy was found to significantly reduce the need for neonatal intubation and shorten NICU stays.

Advancing gestational age also served as a protective factor for neonatal outcomes, indicating that both anesthesia choice and timing of delivery can positively influence the health of newborns in these high-risk pregnancies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of anesthesia selection on neonatal outcomes in cesarean hysterectomies for placenta accreta spectrum (PAS). Munoz, JL., Hernandez, B., Curbelo, J., et al.[2022]

In a study of 122 pregnancies complicated by Placenta Accreta Spectrum (PAS), cesarean hysterectomies performed by gynecologic oncologists showed similar maternal morbidity outcomes compared to those performed by Ob/Gyn specialists, indicating that both specialties can effectively manage these complex cases.

However, gynecologic oncologists were associated with lower rates of intraoperative acidosis and shorter post-operative stays, suggesting they may provide enhanced surgical management in more complicated PAS cases, particularly those involving placenta percreta.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Importance of the gynecologic oncologist in management of cesarean hysterectomy for Placenta Accreta Spectrum (PAS). Munoz, JL., Blankenship, LM., Ramsey, PS., et al.[2022]

In a study involving 148 women with placenta accreta spectrum, conservative management (leaving the placenta in situ) resulted in a significantly lower risk of requiring more than 4 units of blood transfusion compared to cesarean hysterectomy (16.3% vs. 59.0%).

While conservative management had lower rates of severe complications like excessive blood loss and organ injury, it was associated with higher rates of endometritis and readmission, indicating a need for careful consideration of treatment options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Conservative management or cesarean hysterectomy for placenta accreta spectrum: the PACCRETA prospective study. Sentilhes, L., Seco, A., Azria, E., et al.[2022]

Surgical management of placenta accreta spectrum (PAS) is complex and requires careful planning and expertise to ensure safety during procedures.

A multidisciplinary approach to managing PAS can significantly reduce complications and improve outcomes, particularly by minimizing the risk of severe hemorrhage during surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Surgical Techniques for the Management of Placenta Accreta Spectrum. Khoury-Collado, F., Newton, JM., Brook, OR., et al.[2023]

In a study of 62 women with previous cesarean deliveries, 65% required cesarean hysterectomy due to placenta accreta spectrum (PAS), indicating a high prevalence of this condition in high-risk pregnancies.

Textural analysis of MRI images revealed specific features that can predict the need for cesarean hysterectomy, with a notable accuracy (AUC of 0.80), suggesting that these objective radiomics features could enhance the assessment of PAS severity beyond subjective evaluations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MRI of the Placenta Accreta Spectrum (PAS) Disorder: Radiomics Analysis Correlates With Surgical and Pathological Outcome. Do, QN., Lewis, MA., Xi, Y., et al.[2021]

In a study of 442 women with placenta accreta spectrum (PAS), the most common management approach was cesarean hysterectomy, with no maternal deaths reported, indicating a high level of safety in these referral centers.

The study found that prenatal diagnosis of PAS was strongly correlated with the clinical severity of the condition, and there was a significant reduction in mean blood loss over time, suggesting improved management techniques and outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A multicenter observational survey of management strategies in 442 pregnancies with suspected placenta accreta spectrum. van Beekhuizen, HJ., Stefanovic, V., Schwickert, A., et al.[2021]

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