Bilateral Uterine Artery Ligation in PPC Technique for Management of PAS

NCT05314595 | Unknown

• 1 other identifier: PAS
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

Aim of the study Primary outcomes:

1. 1.The effect of bilateral uterine artery ligation in reducing intraoperative bleeding in women underwent PPC as a conservative surgical technique.
2. 2.Decrease surgical time.
3. 3.Associated maternal morbidity and mortality.
4. 4.Amount of blood transfusion
5. 5.Difference in hematocrit value before and after delivery

Conditions

Placenta Accreta

Outcome Measures

Primary Outcomes (1)

• bilateral uterine artery ligation

  1\. The effect of bilateral uterine artery ligation and estimation of blood volume loss (VMBL): direct measurement of blood loss in volume units (mL);

  30 months

Study Arms (1)

modified technique

EXPERIMENTAL

women were underwent modified technique (PPC+ bilateral uterine artery ligation)

Procedure: bilateral uterine artery ligation

Interventions

bilateral uterine artery ligation PROCEDURE

* Spinal anaethesia with intrathecal morphia * Transverse skin incision * Adequate dissection of the bladder. * Incision of the uterus above placental edge. * Delivery of the fetus. * Delayed cord clamping (60 seconds) if the baby appears well. * Exteriorization of the uterus. * Start Oxytocin infusion and uterine massage to ensure good uterine contractions immediately after delivery of the fetus. No trials of placental delivery will be made at this point. * At this point, a gentile trial to deliver the placenta is performed * A catheter is placed in the cervix from above to secure the cervical opening * Compression is applied to the site of bleeding from placenta site * Placental pouch is marked by multiple allies and is closed down to the multiple-8 suture. * Blood loss is measured using the suction device and coated socked towels. In modified PPC, Bilateral uterine artery ligation will be done after exteriorization of the uterus in order to minimize the blood loss.

modified technique

Eligibility Criteria

• Age: 16 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Previous operations
• Gestational age (28 weeks)
• Prenatally suspected PAS based on sonographic and/or MRI findings and/or intrapartum diagnosis of PAS.
• Authorization to participate in the study

You may not qualify if:

• Coagulopathies
• Chronic renal or hepatic impairment (baseline first trimester labs are beyond normal range for pregnancy)
• Delivery in an outside hospital (patients referred for ongoing massive bleeding due to PAS)
• Patients coming in emergency condition with bleeding or in labour.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut Medical School

Asyut, 71511, Egypt

Location

Related Publications (4)

• Cal M, Ayres-de-Campos D, Jauniaux E. International survey of practices used in the diagnosis and management of placenta accreta spectrum disorders. Int J Gynaecol Obstet. 2018 Mar;140(3):307-311. doi: 10.1002/ijgo.12391. Epub 2017 Dec 22.

  PMID: 29149470 BACKGROUND

• Tan CH, Tay KH, Sheah K, Kwek K, Wong K, Tan HK, Tan BS. Perioperative endovascular internal iliac artery occlusion balloon placement in management of placenta accreta. AJR Am J Roentgenol. 2007 Nov;189(5):1158-63. doi: 10.2214/AJR.07.2417.

  PMID: 17954654 BACKGROUND

• Ye M, Yin Z, Xue M, Deng X. High-intensity focused ultrasound combined with hysteroscopic resection for the treatment of placenta accreta. BJOG. 2017 Aug;124(Suppl 3):71-77. doi: 10.1111/1471-0528.14743.

  PMID: 28856861 BACKGROUND

• Silver RM, Landon MB, Rouse DJ, Leveno KJ, Spong CY, Thom EA, Moawad AH, Caritis SN, Harper M, Wapner RJ, Sorokin Y, Miodovnik M, Carpenter M, Peaceman AM, O'Sullivan MJ, Sibai B, Langer O, Thorp JM, Ramin SM, Mercer BM; National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network. Maternal morbidity associated with multiple repeat cesarean deliveries. Obstet Gynecol. 2006 Jun;107(6):1226-32. doi: 10.1097/01.AOG.0000219750.79480.84.

  PMID: 16738145 BACKGROUND

Related Links

• International survey of practices used in the diagnosis and management of placenta accreta spectrum disorders
• Perioperative endovascular internal iliac artery occlusion balloon placement in management of placenta accreta
• High-intensity focused ultrasound combined with hysteroscopic resection for the treatment of placenta accreta
• Placenta accreta spectrum disorder trends in the context of the universal two-child policy in China and the risk of hysterectomy
• Maternal morbidity associated with multiple repeat cesarean deliveries
• Unforeseen consequences of the increasing rate of cesarean deliveries: early placenta accreta and cesarean scar pregnancy. A review

MeSH Terms

Conditions

Placenta Accreta

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Placenta Diseases

Study Officials

• Kamal M Zahran, Professor

  Assiut medical school

  STUDY CHAIR

Central Study Contacts

mostafa hussein

CONTACT

01558678842; mostafa.elnazeir1994@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 11, 2022
• First Posted: April 6, 2022
• Study Start: April 1, 2022
• Primary Completion: August 1, 2022
• Study Completion: September 1, 2022
• Last Updated: April 6, 2022

Record last verified: 2022-04

Locations

EG (1)