Image

Impact Tourniquet Conservative Placenta Accreta Neonatal APGAR

Impact Tourniquet Conservative Placenta Accreta Neonatal APGAR

Recruiting
20-40 years
Female
Phase N/A

Powered by AI

Overview

Placenta accreta spectrum disorder (PAS) refers to a condition where the placenta fails to separate naturally after childbirth, which can cause significant maternal and neonatal complications, including severe bleeding, leading to increased morbidity and mortality. According to the pathological characteristics, PAS can be classified into three categories, including placenta accreta, placenta increta, and placenta percreta. Risk factors for PAS were identified as cesarean section (CS), hysteroscopy history, in vitro fertilization and embryo transfer and placenta previa, etc. It was reported that over 90% of the PAS cases were with prior cesarean delivery. In order to reduce the morbidity and mortality caused by PAS, guidelines were released from several international societies, including the Federation of Gynecology and Obstetrics (FIGO), Royal College of Obstetricians and Gynecologists (RCOG), the American College of Obstetricians and Gynecologists (ACOG) and Society of Obstetricians and Gynecologists of Canada (SOGC) recommending comprehensive multidisciplinary team (MDT) and expertise in pelvic and abdominal surgeries are essential for patients with PAS. Antenatal diagnosis of PAS is highly advisable, which is closely associated with surgery options, bleeding management and success of uterine preservation. Current diagnostic approaches include imaging examination, PAS prenatal grading system and MDT. Severe complications of PAS (particularly in the case of PP), such as substantial hemorrhage and organ injury, are closely related to the placental position and trophoblast invasion depth. Ultrasonography and MRI are major imaging means for prenatal diagnosis. In the meantime, to preserve fertility, approaches to conservative surgical management for PAS have been developed. The purpose for conservative management of PAS patients is to reduce bleeding, avoid organ injury, preserve the uterus and maintain uterine function. As the concept of uterine preservation is accepted by more and more practitioners, conservative surgical techniques have been developed accordingly. According to the survey of the Society for Maternal-Foetal Medicine (SMFM), only 15-32% of doctors would apply conservative management for PAS cases. Due to the lack of high-quality clinical trials as well as follow-up studies, standardized surgical management for PAS has not yet been determined. There are three approaches applied to placenta management in PAS, including manual separation of placenta, one-step conservative surgery and leaving the placenta in situ. Removing the complete placenta can effectively reduce bleeding and infection and preserve the uterus. The classical "Triple-P" management was proposed in 2012, which includes perioperative placental localization, pelvic devascularization and placental non-separation with myometrial excision and uterine reconstruction. The uterine artery tourniquet has numerous advantages, including a decrease in blood loss and the number of transfused packed RBC units. The simplicity of the technique allows for residents to apply the tourniquet to decrease the bleeding and allows time until an experienced obstetrician arrives. Presently, other attempts to avoid hysterectomy include uterine compression sutures, intrauterine balloon tamponade, pelvic artery ligation, and spiral suturing of the lower uterine segment. Intrauterine balloon tamponade may increase CS scar dehiscence, uterine rupture, and infection. Best practices for these methods involve skilled surgeons and obstetricians who have detailed knowledge of pelvic artery anatomy that includes vascular variations or distortions. The Apgar score was established in 1953 as a rapid newborn assessment immediately after birth. It provides a mechanism to describe the situation of the fetus becoming a newborn. Physicians face many challenges in analyzing the fetus' transition into a baby in the delivery room, especially for premature ones. The Apgar score is usually used to analyze the newborn after birth in the delivery room briefly. Thus, the Apgar score analyzes the clinical signs in neonates, such as cyanosis, pallor, bradycardia, decreased reflex response to stimulation, hypotonia, and apnea, or breathing problems such as abnormal rate and tachypnea as quantitative data. The Apgar score is reported at 1 and 5 min after birth and repeated every 5 min up to 20 min for infants with an Apgar score \<7. A peculiar step of such a surgical approach involves the ligature of newly formed vessels between the uterus and the bladder. It has been speculated that such a step may affect the newborn by reducing blood flow to the placenta. This study aimed to report the neonatal outcome of women undergoing conservative reconstructive technique for PAS.

Eligibility

Inclusion Criteria:

  1. Age: 20-40 years old.
  2. Pregnancy of a singleton living fetus.
  3. Gestational age: pregnancy completing 34 weeks or more.
  4. Previous one or more cesarean delivery.
  5. Current pregnancy complicated by Placena Accreta Spectrum Disorder candidate for conservative managment either total or partial Placenta Accreta.
  6. Elective termination of pregnancy. (35-37 weeks)
  7. Preoperative Hemoglobin ≥ 10 g/dl.

Exclusion Criteria:

  • 1-Patients who refuse to participate in the study. 2-Women with history of a concomitant chronic or a pregnancy associated medical disorder eg. Gestational diabetes, hypertension, cardiac or renal disease.

    3-Presence of a concomitant uterine pathology (eg. Uterine fibroid) 4-Premature rupture of membranes. 5-Cases misdiagnosed as placenta accreta by ultrasound preoperatively, and spontaneous full placental separation occurred intraoperative or as total/partial accreta and found to be focal accreta intraoperative.

    6-Cases requiring preoperative blood transfusion. 7- Any fetal abnormality e.g IUGR or SGA

Study details
    Pregnancy
    Placenta Accrete Spectrum
    Tourniquets
    Apgar Score

NCT07412925

Kasr El Aini Hospital

26 February 2026

Step 1 Get in touch with the nearest study center
We have submitted the contact information you provided to the research team at {{SITE_NAME}}. A copy of the message has been sent to your email for your records.
Would you like to be notified about other trials? Sign up for Patient Notification Services.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

  Other languages supported:

First name*
Last name*
Email*
Phone number*
Other language

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.