New Conservative Technique for Placenta Accreta Spectrum (percreta)
Primary Purpose
Placenta Accreta Spectrum
Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
ultrasound
closure of uterine wall defect
Sponsored by
About this trial
This is an interventional treatment trial for Placenta Accreta Spectrum
Eligibility Criteria
Inclusion Criteria:
- pregnant women diagnosed as placenta accreta spectrum with previous Cesarean section, with or without other uterine surgeries and less than 40 years of age.
Exclusion Criteria:
- pregnant women having medical conditions such as cardiac diseases, coagulopathy and hematological disorders.
pregnant women had 5 or more previous Cesarean sections or their age more than 40 years
Sites / Locations
- Faculty of MedicineRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
pregnant women with placenta accreta spectrum
Arm Description
The participants were subjected to ultrasound to diagnose placenta accreta spectrum followed by new conservative surgical technique.
Outcomes
Primary Outcome Measures
surgical outcome
number of participants whom their uterus were preserved without major hemorrhage
intra-operative blood loss
the amount of blood loss during operation was estimated for each participant.
surgical complications
number of participants had bladder, ureter injury or hysterectomy,
internal iliac artery ligation
number of participants had with either unilateral or bilateral internal iliac artery ligation
high dependency unit admission
number of participants needed high dependency unit admission
wound complications
number of patients suffered wound infection
change in the hemoglobin level
participant's hemoglobin was measured
blood transfusion
number of units of blood and it's products transfused to participants
hematuria
number of participants suffered hematuria
manual cervical assesment
participants were subjected to vaginal examination to asses the cervix lenght
placental separation
number of participants whom their placenta was separated manually
surgical grading of the placenta
number of participants who had accreta, increta, percreta or mixed type
ultrasound grading of the placenta
number of participants who were diagnosed by ultrasound as accreta, increta or percreta
manual assessment of vaginal fornices
participants were subjected to vaginal examination to assess fornices
repair time
the time recorded from the end of the placental separation to the closure of the first layer of the uterus
total operation time
the time taken from the start of the skin incision to the skin closure
Secondary Outcome Measures
placental bed
number of participants that investigators detected a well delineated placental bed like a pouch
pouch site
the site of the pouch in relation to the cervix
defect site
the location of the myometrium defects
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04427592
Brief Title
New Conservative Technique for Placenta Accreta Spectrum
Acronym
percreta
Official Title
Placenta Accreta; A Vision for Conservative Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 28, 2020 (Actual)
Primary Completion Date
April 20, 2023 (Anticipated)
Study Completion Date
May 20, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Alexandria University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
participants diagnosed as placenta accreta spectrum were subjected to cesarean delivery.
Investigators manually detected a plan of cleavage through which the placenta was separated followed by closure of defective placental bed.
Data were collected about the outcome.
Detailed Description
Demographic data, detailed history taking, routine blood tests were done. Trans-abdominal and trans-vaginal ultrasound to diagnose placenta accreta spectrum ( PAS). Detecting new signs to help sure diagnosis of PAS.
Cesarean section will be performed through extended transverse supra-pubic incision bladder dissection from anterior uterine wall using electro-coagulation instruments and double ligation of large caliber bridging vessels.
Uterine incision above the placental bulge by at least 5 mm then complete separation of the placenta starting from least resistance plans to high resistant one leaving a clear defect which will be closed by running sutures from inside the uterus and controlling placental bed hemorrhage then closing the uterine incision with compressing the bed from outwards ( double compression sutures ) internal Iliac artery ligation may be done as a complementary measure to control the bleeding from abnormal pelvic vasculature, insertion of intraperitoneal drain and closure of abdominal wall in layers.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Placenta Accreta Spectrum
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Investigators conducting prospective study for management of placenta accreta spectrum including diagnosis and uterine sparing surgery.
Masking
None (Open Label)
Allocation
N/A
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
pregnant women with placenta accreta spectrum
Arm Type
Experimental
Arm Description
The participants were subjected to ultrasound to diagnose placenta accreta spectrum followed by new conservative surgical technique.
Intervention Type
Diagnostic Test
Intervention Name(s)
ultrasound
Intervention Description
trans-vaginal and trans-abdominal ultrasound using different modalities such as grey-scale, Doppler, multi-planer mode
Intervention Type
Procedure
Intervention Name(s)
closure of uterine wall defect
Other Intervention Name(s)
Double compression suture
Intervention Description
uterine incision above placental bulge by at least 5 mm then complete separation of the placenta starting from areas of least resistance to areas of high resistance leaving a clear defect which will be closed by non locked running sutures from inside the uterus starting from one edge, hitch the bed to the other edge of the defect and controlling placental bed hemorrhage then closing the uterine incision via running sutures in 2 layers with compressing the bed from outwards in the first layer. hemostasis of the abnormal pelvic vasculature if excessive bleeding internal iliac artery may be ligated then insertion of intra-peritoneal drain followed by closing the abdomen.
Primary Outcome Measure Information:
Title
surgical outcome
Description
number of participants whom their uterus were preserved without major hemorrhage
Time Frame
from the time of the surgery until 48 hours after.
Title
intra-operative blood loss
Description
the amount of blood loss during operation was estimated for each participant.
Time Frame
intraoperative
Title
surgical complications
Description
number of participants had bladder, ureter injury or hysterectomy,
Time Frame
intraoperative
Title
internal iliac artery ligation
Description
number of participants had with either unilateral or bilateral internal iliac artery ligation
Time Frame
intra-operative
Title
high dependency unit admission
Description
number of participants needed high dependency unit admission
Time Frame
from 0 to 48 hours postoperative
Title
wound complications
Description
number of patients suffered wound infection
Time Frame
up to 2 weeks postoperative
Title
change in the hemoglobin level
Description
participant's hemoglobin was measured
Time Frame
from 48 hours pre operative to 48 hours post operative
Title
blood transfusion
Description
number of units of blood and it's products transfused to participants
Time Frame
from 48 hours preoperative to 48 hours postoperative.
Title
hematuria
Description
number of participants suffered hematuria
Time Frame
post-operative up to 24 hours
Title
manual cervical assesment
Description
participants were subjected to vaginal examination to asses the cervix lenght
Time Frame
before skin incision
Title
placental separation
Description
number of participants whom their placenta was separated manually
Time Frame
intra-operative
Title
surgical grading of the placenta
Description
number of participants who had accreta, increta, percreta or mixed type
Time Frame
intra-operative
Title
ultrasound grading of the placenta
Description
number of participants who were diagnosed by ultrasound as accreta, increta or percreta
Time Frame
pre-operative
Title
manual assessment of vaginal fornices
Description
participants were subjected to vaginal examination to assess fornices
Time Frame
before skin incision
Title
repair time
Description
the time recorded from the end of the placental separation to the closure of the first layer of the uterus
Time Frame
intra-operative
Title
total operation time
Description
the time taken from the start of the skin incision to the skin closure
Time Frame
intra-operative
Secondary Outcome Measure Information:
Title
placental bed
Description
number of participants that investigators detected a well delineated placental bed like a pouch
Time Frame
intra-operative
Title
pouch site
Description
the site of the pouch in relation to the cervix
Time Frame
intra-operative
Title
defect site
Description
the location of the myometrium defects
Time Frame
intra-operative
Other Pre-specified Outcome Measures:
Title
new ultrasound sign the pouch
Description
number of participants that the investigators detected the previously noticed pouch by ultrasound.
Time Frame
pre-operative
Title
significance of the pouch
Description
the investigators determine the relation of the pouch to estimated blood loss
Time Frame
peri-operative
Title
Pathology
Description
Histopathological examination of 1 cm specimen from the myometriam attached to the placenta in random cases
Time Frame
From the operation time for 48 hours
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
pregnant women diagnosed as placenta accreta spectrum with previous Cesarean section, with or without other uterine surgeries and less than 40 years of age.
Exclusion Criteria:
pregnant women having medical conditions such as cardiac diseases, coagulopathy and hematological disorders.
pregnant women had 5 or more previous Cesarean sections or their age more than 40 years
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mahmoud AH Hamdy, A. lecturer
Phone
00201229102311
Email
mahmoud_hamdy81@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Omar YS Elshorbagy, A. lecturer
Phone
00201111362322
Email
oyke2011@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mahmoud AH Hamdy, A. lecturer
Organizational Affiliation
faculty of medicine department of obstetrics and gyneacology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Medicine
City
Alexandria
ZIP/Postal Code
21131
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mahmoud AH Hamdy, A. lecturer
First Name & Middle Initial & Last Name & Degree
Omar YS Elshorbagy, A. lecturer
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
all IPD that underlies results in publication
IPD Sharing Time Frame
after publication by 1 month
Citations:
PubMed Identifier
29405320
Citation
Sentilhes L, Kayem G, Chandraharan E, Palacios-Jaraquemada J, Jauniaux E; FIGO Placenta Accreta Diagnosis and Management Expert Consensus Panel. FIGO consensus guidelines on placenta accreta spectrum disorders: Conservative management. Int J Gynaecol Obstet. 2018 Mar;140(3):291-298. doi: 10.1002/ijgo.12410. No abstract available.
Results Reference
result
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New Conservative Technique for Placenta Accreta Spectrum
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