Impact Tourniquet Conservative Placenta Accreta Neonatal APGAR

Impact of Using Tourniquet in Conservative Placenta Accrete Spectrum on Neonatal APGAR Score . A Randomized Controlled Trial .

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.

Study Overview

• Status: Recruiting
• Conditions: Pregnancy; Apgar Score; Tourniquets; Placenta Accrete Spectrum
• Intervention / Treatment: Procedure: Application Of A Tourniquet Around the lower segment of the uterus; Procedure: Placenta Accreta spectrum conservative management

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yassmine A Hamouda, MSC; Phone Number: 00201001680580; Email: yassmineamrabdelmegid@hotmail.com
• Study Contact Backup: Name: Abdallah M Mousa, MD; Phone Number: 0020127664430; Email: Dr_abdallahmousa@yahoo.com

Study Locations

• Egypt
  • Cairo, Egypt
    • Recruiting
    • kasr Al Aini Hospitals , Faculty of medicine , Cairo University , Cairo
    • Contact: Abdallah M Mousa, MD; Phone Number: 0020127664430; Email: Dr_abdallahmousa@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Tourniquet Group A; 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; 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
Placebo Comparator: Non-Tourniquet group (B); 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; No tourniquet is applied around the lower uterine segment: Same technique without adding a temporary tourniquet around the uterine artery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neonatal encephalopathy	Neonatal encephalopathy is a clinically defined syndrome of disturbed neurologic function in the earliest days of life in an infant born at or beyond 35 weeks of gestation, manifested by a subnormal level of consciousness or seizures, and often accompanied by difficulty with initiating and maintaining respiration and depression of tone and reflexes	Immediately after birth
Gestational age	According to American College of Obstetricians and Gynecologists, the main methods to calculate gestational age are; Directly calculating the days since the beginning of the last menstrual period; Early obstetric ultrasound, comparing the size of an embryo or fetus to that of a reference group of pregnancies of known gestational age (such as calculated from last menstrual periods) and using the mean gestational age of other embryos or fetuses of the same size. If the gestational age as calculated from an early ultrasound is contradictory to the one calculated directly from the last menstrual period, it is still the one from the early ultrasound that is used for the rest of the pregnancy.(21)	preoperative
Birthweight	Birthweight measured in grams.	immediately postoperative
Requirement for oxygen support	in the form of supplementary oxygen, nasal positive pressure ventilation or mechanical ventilatory support	immediately postoperative
NICU	Admission to neonatal intensive care unit (NICU) and the length of NICU stay in days.	immediately postoperative
Early Neonatal Mortality	Early neonatal mortility	one week
Operative time	the time from bladder dissection , till uterine closure	intraoperative
Incidence of bleeding	No of packed Rbcs that the patient required to be transfused according to the vital status of the patient as well as postoperative according to vital status of the patient and hemoglobin level postoperative , as well as the amount of bleeding that occured either intraoperative r postoperative	perioperative and immediately postoperative
Incidence of complications	Internal organ injury (Bladder, intestine, ureter) as well as Inadvertent injury to the pelvic vessels (eg. Injury to the ovarian vessels while inserting the tourniquet)	intraoperative
Incidence of ICU admission	ICU admission incidence	immediately postoperative and up to 48 hours
Duration of hospital stay	Usually length of hospital stay for a placenta accreta spectrum patient without icu admission around 48 hours , and if icu admission happens for 1 or 2 days then 48 more hours after discharge from icu	from 48 hours to 72 hours

Collaborators and Investigators

• Sponsor: Kasr El Aini Hospital

Publications and helpful links

General Publications

• - 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 30, 2025
• Primary Completion (Estimated): March 1, 2026
• Study Completion (Estimated): March 1, 2026

Study Registration Dates

• First Submitted: November 21, 2025
• First Submitted That Met QC Criteria: February 9, 2026
• First Posted (Actual): February 17, 2026

Study Record Updates

• Last Update Posted (Actual): February 17, 2026
• Last Update Submitted That Met QC Criteria: February 9, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Tourniquet; conservative; APGAR score; placenta Accrete
• Other Study ID Numbers: MD-453-2024

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No