Bilateral Uterine Artery Ligation in PPC Technique for Management of PAS
Primary Purpose
Placenta Accreta
Status
Not yet recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
bilateral uterine artery ligation
Sponsored by
About this trial
This is an interventional treatment trial for Placenta Accreta
Eligibility Criteria
Inclusion Criteria:
• 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
Exclusion Criteria:
• 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.
Sites / Locations
- Assiut Medical School
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
modified technique
Arm Description
women were underwent modified technique (PPC+ bilateral uterine artery ligation)
Outcomes
Primary Outcome Measures
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);
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05314595
Brief Title
Bilateral Uterine Artery Ligation in PPC Technique for Management of PAS
Official Title
The Effect of Bilateral Uterine Artery Ligation as an Added Step for Placental Pouch Closure Technique in Management of Placenta Accreta Spectrum on Reducing Intra-operative Blood Loss: A Comparative Study
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
April 1, 2022 (Anticipated)
Primary Completion Date
August 1, 2022 (Anticipated)
Study Completion Date
September 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. Study Description
Brief Summary
Aim of the study
Primary outcomes:
The effect of bilateral uterine artery ligation in reducing intraoperative bleeding in women underwent PPC as a conservative surgical technique.
Decrease surgical time.
Secondary outcomes:
Associated maternal morbidity and mortality.
Amount of blood transfusion
Difference in hematocrit value before and after delivery
Detailed Description
Introduction Placenta accreta spectrum (PAS) is a term that comprises abnormal placental invasion disorders of the uterine wall. According to the depth of invasion, it ranges from placental invasion in contact with myometrium (placenta accreta), into myometrium (placenta increta), or beyond myometrium (placenta percreta) (Tan, Tay et al. 2007, Cal, Ayres-de-Campos et al. 2018). PAS is an obstetric emergency that may be complicated by emergency hysterectomy, intraoperative surgical complications, massive transfusion, hemorrhagic shock, and even maternal death if not managed efficiently (Ye 2017). Previous cesarean deliveries, placenta previa and advanced maternal age are recognized strong risk factors of PAS, all of which, have become more prevalent among contemporary population (Silver, Landon et al. 2006, Zeng, Yang et al. 2018). Therefore, PAS is no longer a rare disorder in modern practice; the incidence of PAS has increased from approximately 1 in 30,000 deliveries before 1950 to 3 in 1000 deliveries in the current decade (Timor-Tritsch, Monteagudo et al. 2012).
Currently, cesarean hysterectomy is the standard management of PAS (Matsubara, Kuwata et al. 2013). Despite surgical risks, loss of uterine function, and psychological sequences, cesarean hysterectomy permits elective intervention under controlled settings to minimize blood loss (2002). Although several uterus-conserving interventions have been proposed in management of PAS, their contribution to evidence-based practice is limited (Jauniaux, Alfirevic et al. 2018), and cesarean hysterectomy is endorsed as the standard intervention (gynaecology, Gynaecology et al. 2002). Cesarean hysterectomy, without attempting to remove the placenta, may reduce risk of significant bleeding and associated morbidity (Eller, Porter et al. 2009). Leaving the placenta in situ is endorsed as an alternative in patients who refuse hysterectomy being the least invasive uterus-conserving intervention (Jauniaux, Alfirevic et al. 2018, Sentilhes, Kayem et al. 2018).
Nevertheless, the need for evidence-based conservative approaches for PAS cannot be underestimated particularly among women who are highly motivated to preserve their fertility. Despite limited evidence, an international survey indicates that 39% of obstetricians consider conservative management as the primary management. Notably, conservative management was inconsistent among respondents (Cal, Ayres-de-Campos et al. 2018).
Placental pouch closure looks to be an attractive and effective surgical procedure for conservative management of placenta accreta (Zahran, Elsonbaty et al. 2020). In their series of 60 Placenta accreta cases reported that by using this technique,59 out of the 60 enrolled cases, the uterus was successfully conserved and there were no cases of maternal mortality or severe morbidities related to the procedure.
Major blood supply of the uterus comes from the uterine artery, so bilateral uterine artery ligation (UAL) before delivering of the placenta greatly decreasing the blood loss(Lin, Lin et al. 2019). Simultaneously, the ovarian blood flow has not been affected and consequently no changes in ovarian reserve markers occurred, so it is considered one of preserving fertility surgical technique (Verit, Çetin et al. 2019).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Placenta Accreta
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
130 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
modified technique
Arm Type
Experimental
Arm Description
women were underwent modified technique (PPC+ bilateral uterine artery ligation)
Intervention Type
Procedure
Intervention Name(s)
bilateral uterine artery ligation
Intervention Description
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.
Primary Outcome Measure Information:
Title
bilateral uterine artery ligation
Description
1. The effect of bilateral uterine artery ligation and estimation of blood volume loss (VMBL): direct measurement of blood loss in volume units (mL);
Time Frame
30 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
• 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
Exclusion Criteria:
• 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
mostafa hussein
Phone
01558678842
Email
mostafa.elnazeir1994@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kamal M Zahran, Professor
Organizational Affiliation
Assiut medical school
Official's Role
Study Chair
Facility Information:
Facility Name
Assiut Medical School
City
Assiut
ZIP/Postal Code
71511
Country
Egypt
12. IPD Sharing Statement
Citations:
PubMed Identifier
29149470
Citation
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.
Results Reference
background
PubMed Identifier
17954654
Citation
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.
Results Reference
background
PubMed Identifier
28856861
Citation
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.
Results Reference
background
PubMed Identifier
16738145
Citation
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.
Results Reference
background
Links:
URL
https://pubmed.ncbi.nlm.nih.gov/29149470/
Description
International survey of practices used in the diagnosis and management of placenta accreta spectrum disorders
URL
https://pubmed.ncbi.nlm.nih.gov/17954654/
Description
Perioperative endovascular internal iliac artery occlusion balloon placement in management of placenta accreta
URL
https://pubmed.ncbi.nlm.nih.gov/28856861/
Description
High-intensity focused ultrasound combined with hysteroscopic resection for the treatment of placenta accreta
URL
https://pubmed.ncbi.nlm.nih.gov/29214633/
Description
Placenta accreta spectrum disorder trends in the context of the universal two-child policy in China and the risk of hysterectomy
URL
https://pubmed.ncbi.nlm.nih.gov/16738145/
Description
Maternal morbidity associated with multiple repeat cesarean deliveries
URL
https://pubmed.ncbi.nlm.nih.gov/22516620/
Description
Unforeseen consequences of the increasing rate of cesarean deliveries: early placenta accreta and cesarean scar pregnancy. A review
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Bilateral Uterine Artery Ligation in PPC Technique for Management of PAS
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