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PregnancyNCT07412925

Impact Tourniquet Conservative Placenta Accreta Neonatal APGAR

A study testing Application Of A Tourniquet Around the lower segment of the uterus and Placenta Accreta spectrum conservative management in people with Pregnancy and Placenta Accrete Spectrum, run by Kasr El Aini Hospital at 1 site in Egypt.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 to 40 years, women only
Conditions the study is for
Pregnancy, Placenta Accrete Spectrum, Tourniquets
What is being tested?
Application Of A Tourniquet Around the lower segment of the uterus and Placenta Accreta spectrum conservative management
Type of treatment
Surgery or procedure
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
100 participants
Where
1 siteEgypt
Study dates
30 Apr 2025to 1 Mar 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 40 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Abdallah M Mousa, MD contact

0020127664430

Dr_abdallahmousa@yahoo.com

Egypt1 site, 1 recruiting
  • kasr Al Aini Hospitals , Faculty of medicine , Cairo University , Cairo

    Cairo

    Abdallah M Mousa, MD, 0020127664430, Dr_abdallahmousa@yahoo.com

    Recruiting

Other trials in Egypt

About this study

Official title: 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.

Being tested
Application Of A Tourniquet Around the lower segment of the uterus, Placenta Accreta spectrum conservative management
Keywords
placenta Accrete, Tourniquet, conservative, APGAR score

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Application Of A Tourniquet Around the lower segment of the uterusProcedure or surgery

    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

  • Placenta Accreta spectrum conservative managementProcedure or surgery

    No tourniquet is applied around the lower uterine segment:

    Same technique without adding a temporary tourniquet around the uterine artery.

Study groups in NCT07412925
Study groupRoleWhat they receive
Tourniquet Group AActive comparatorFoley 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
Receives: Procedure: Application Of A Tourniquet Around the lower segment of the uterus
Non-Tourniquet group (B)Placebo comparatorNo tourniquet is applied around the lower uterine segment: Same technique without adding a temporary tourniquet around the uterine artery.
Receives: Procedure: Placenta Accreta spectrum conservative management

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 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)
  1. 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

    Measured: Immediately after birth

  2. 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)

    Measured: preoperative

  3. Birthweight

    Birthweight measured in grams.

    Measured: immediately postoperative

  4. Requirement for oxygen support

    in the form of supplementary oxygen, nasal positive pressure ventilation or mechanical ventilatory support

    Measured: immediately postoperative

  5. NICU

    Admission to neonatal intensive care unit (NICU) and the length of NICU stay in days.

    Measured: immediately postoperative

  6. Early Neonatal Mortality

    Early neonatal mortility

    Measured: one week

  7. Operative time

    the time from bladder dissection , till uterine closure

    Measured: intraoperative

  8. 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

    Measured: perioperative and immediately postoperative

  9. 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)

    Measured: intraoperative

  10. Incidence of ICU admission

    ICU admission incidence

    Measured: immediately postoperative and up to 48 hours

  11. 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

    Measured: from 48 hours to 72 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Feb 2026
  2. Study start30 Apr 2025
  3. Primary completion1 Mar 2026 (estimated)
  4. Study completion1 Mar 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
randomized control trial formed of two groups group A receiving tourniquet group B control group
Masking
Single blind
Who is masked
Participant
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07412925
Sponsor's protocol ID
MD-453-2024
Status last verified
Feb 2026
First submitted
21 Nov 2025
Last updated
17 Feb 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

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 Pract Res Clin Obstet Gynaecol. 2021 Apr;72:102-116. doi: 10.1016/j.bpobgyn.2020.06.007. Epub 2020 Jun 27.

    PubMed 32698993
  • 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. eCollection 2020.

    PubMed 33204176

Questions about this trial

What is this clinical trial studying?

A study testing Application Of A Tourniquet Around the lower segment of the uterus and Placenta Accreta spectrum conservative management in people with Pregnancy and Placenta Accrete Spectrum, run by Kasr El Aini Hospital at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Yassmine A Hamouda, MSC (00201001680580, yassmineamrabdelmegid@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Neonatal Apgar Score (time frame: 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07412925, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2026.

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