Impact Tourniquet Conservative Placenta Accreta Neonatal APGAR

NCT07412925 | Recruiting DMC

• 1 other identifier: MD-453-2024
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pregnancy; Placenta Accrete Spectrum; Apgar Score; Tourniquets

Keywords

placenta Accrete; Tourniquet; conservative; APGAR score

Outcome Measures

Primary Outcomes (1)

• Neonatal Apgar Score

  This scoring system provided a standardized assessment for infants after delivery. The Apgar score comprises five components: 1) color, 2) heart rate, 3) reflexes, 4) muscle tone, and 5) respiration, each of which is given a score of 0, 1, or 2. Thus, the Apgar score quantitates clinical signs of neonatal depression such as cyanosis or pallor, bradycardia, depressed reflex response to stimulation, hypotonia, and apnea or gasping respirations. The score is reported at 1 minute and 5 minutes after birth for all infants, and at 5-minute intervals thereafter until 20 minutes for infants with a score less than

  1 min and 5 mins after birth for all infants , and if after 5 mins score is less than 7 , scoring will continue every 5 mins till 20 mins

Secondary Outcomes (11)

• Neonatal encephalopathy

  Immediately after birth

• Gestational age

  preoperative

• Birthweight

  immediately postoperative

• Requirement for oxygen support

  immediately postoperative

• NICU

  immediately postoperative

Study Arms (2)

Tourniquet Group A

ACTIVE COMPARATOR

Foley catheter (20Fr) will be applied around the lower uterine segment at level lower than the placenta acting as a tourniquet The dissection of the utero-vesical fold will be extended laterally to both broad ligaments \& bilateral opening in the anterior leaflet of the broad ligament will be made. Both ureters will be identified beforehand. Foley catheter will be passed through the posterior leaflet of the left broad ligament in an avascular area, then passing the catheter back through Douglas pouch through the right broad ligament.The Foley catheter tourniquet will include both the lower uterine segment \& part of the bladder dome. supra-placental hysterotomy incision is carried out immediately after tightening the tourniquet followed by fetal extraction with immediate cord clamping (\< 30 seconds).The uterus is then exteriorized, kept under upward traction so uterine vascular constriction can diminish blood loss \& the hysterotomy incision bleeding is temporarily control by towel clips

Procedure: Application Of A Tourniquet Around the lower segment of the uterus

Non-Tourniquet group (B)

PLACEBO COMPARATOR

No tourniquet is applied around the lower uterine segment: Same technique without adding a temporary tourniquet around the uterine artery.

Procedure: Placenta Accreta spectrum conservative management

Interventions

Application Of A Tourniquet Around the lower segment of the uterus PROCEDURE

Foley catheter (20Fr) will be applied around the lower uterine segment at level lower than the placenta acting as a tourniquet The dissection of the utero-vesical fold will be extended laterally to both broad ligaments \& bilateral opening in the anterior leaflet of the broad ligament will be made. Both ureters will be identified beforehand. Foley catheter will be passed through the posterior leaflet of the left broad ligament in an avascular area, then passing the catheter back through Douglas pouch through the right broad ligament.The Foley catheter tourniquet will include both the lower uterine segment \& part of the bladder dome. supra-placental hysterotomy incision is carried out immediately after tightening the tourniquet followed by fetal extraction with immediate cord clamping (\< 30 seconds).The uterus is then exteriorized, kept under upward traction so uterine vascular constriction can diminish blood loss \& the hysterotomy incision bleeding is temporarily control by towel clips

Tourniquet Group A

Placenta Accreta spectrum conservative management PROCEDURE

No tourniquet is applied around the lower uterine segment: Same technique without adding a temporary tourniquet around the uterine artery.

Non-Tourniquet group (B)

Eligibility Criteria

• Age: 20 Years - 40 Years
• Gender Eligibility Details: female pregnant 20
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Kasr El Aini Hospital: lead

Study Sites (1)

kasr Al Aini Hospitals , Faculty of medicine , Cairo University , Cairo

Cairo, Egypt

RECRUITING

Related Publications (3)

• - Obstetrics Subgroup SoOaG, Chinese Medical Association; Maternal and Fetal Medicine Special Committee of Obstetrics and Gynecology Branch of Chinese Medical Doctor Association. Guideline for diagnosis and treatment of placenta accreta spectrum disorders. Chinese Journal of Perinatal Medicine.2023;26(08):617-627.

  RESULT

• Jauniaux E, Kingdom JC, Silver RM. A comparison of recent guidelines in the diagnosis and management of placenta accreta spectrum disorders. Best Practice & Research Clinical Obstetrics & Gynaecology. 2021;72:102-116.

  RESULT

• Morlando M, Collins S. Placenta Accreta Spectrum Disorders: Challenges, Risks, and Management Strategies. Int J Womens Health. 2020 Nov 10;12:1033-1045. doi: 10.2147/IJWH.S224191. PMID: 33204176; PMCID: PMC7667500.

  RESULT

Central Study Contacts

Yassmine A Hamouda, MSC

CONTACT

00201001680580; yassmineamrabdelmegid@hotmail.com

Abdallah M Mousa, MD

CONTACT

0020127664430; Dr_abdallahmousa@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Demonstrator and Assistant Lecturer

Model Details: randomized control trial formed of two groups group A receiving tourniquet group B control group

Study Record Dates

• First Submitted: November 21, 2025
• First Posted: February 17, 2026
• Study Start: April 30, 2025
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: February 17, 2026

Record last verified: 2026-02

Locations

EG (1)