Conservative Surgery for Abnormally Invasive Placenta: A New Technique
Primary Purpose
Placenta Accreta
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Conservative surgery for placenta accretta
Sponsored by
About this trial
This is an interventional treatment trial for Placenta Accreta
Eligibility Criteria
Inclusion Criteria:
Placenta accreta spectrum, with partial or total invasion With area of invasion more than 7 cm in diameter
- patient's informed consent about the future risks of conservative management
- pregnancy > 20 weeks
Exclusion Criteria:
* deeply pelvic placenta accreta spectrum cases with cervical invasion , by transvaginal ultrasound cervical length less than 21 mm
- cases with total invasion in which the area of invasion is more than 20 min diameter
- patient refusing conservative management and opting for hysterectomy
- medical comorbidities making massive hemorrhage more likely such as coagulopathies
- patient is in active antepartum hemorrhage
Sites / Locations
- Kasr Alainy medical school
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Conservative surgery for placenta accretta
Arm Description
Outcomes
Primary Outcome Measures
intraoperative blood loss
Blood loss = estimated blood volume (EBV) x preoperative hematocrit - postoperative hematocrit/preoperative hematocrit another method by weighing the towels and dressings before and after the procedure and adding the volume of fluid inside the suction apparatus
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04193618
Brief Title
Conservative Surgery for Abnormally Invasive Placenta: A New Technique
Official Title
Conservative Surgery for Abnormally Invasive Placenta: A New Technique
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
December 11, 2020 (Actual)
Study Completion Date
March 6, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo 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
Placental borders and mapping by ultrasonography and Doppler ultrasonography (placental mapping) preop. And verified intraoperatively .
bladder peritoneal dissection till the level of internal Os Uterus is incised away from the placenta
*Baby was delivered , the uterus is exteriorised and 4-5 towel clips are applied rapidly control uterine incision site bleeding .
Twenty units of diluted oxytocin and 100 to 200 cc, 37°C of heated saline were infused from here, and then the cord was clamped .
Then we proceed to systemically devascularize the uterus with the placenta in site
internal iliac artery distal ligation:
broad ligament and ureteric dissection:
uterine vessels :
posterior uterine wall compression suture :
The utero-ovarian anastomosis branches are spared to keep blood flowing to the uterus.
if the bladder was not fully dissected from the anterior uterine wall , now we complete the dissection,
anterior uterine wall compression suture :
now , we excise the invaded , irreparable anterior wall segment, with the
then separation of the placenta manually
if there's still mild bleeding from the uterine placental bed another full myometrial thickness anterior or posterior uterine wall transverse sutures are applied below or above the placental bed site to control bleeding until it's deemed acceptable
in cases with separate fundal anterior incision, the high incision is repaired in layers first to give more time to compress and monitor the lower segment
refashioning of the Lower segment , repair transversely is usually done,
Detailed Description
Placental borders and mapping were detected carefully by ultrasonography and Doppler ultrasonography (placental mapping) preop. And verified intraoperatively ..
According to the mapping, in a subset of patients we entered the abdomen by transverse suprapubic incision; in another subset we entered the abdomen by infraumbilical midline incision which was extended to a supra umbilical one in cases with anterior placentae with high upper margin .
Followed by bladder peritoneal dissection till either the level of internal Os is reached or a level with extensive adherence and/ or invasion.
Uterus is incised away from the placenta, according to the plan we described by placental mapping.
Type of uterine incisions is determined after placental mapping. Placental borders have been identified, and incisions were made far away from placenta. J-shaped, vertical and upper transverse incisions were used .
In cases of high anterior wall placentae a fundal anterior incision is made separate from the placental invaded uterine segment that will be excised later and both incisions will be repaired separately ..
Baby was delivered , the uterus is exteriorised and 4-5 towel clips are applied rapidly control uterine incision site bleeding .
Twenty units of diluted oxytocin and 100 to 200 cc, 37°C of heated saline were infused from here, and then the cord was clamped .
Then we proceed to systemically devascularize the uterus with the placenta in site
internal iliac artery distal ligation: posterior pelvic peritoneum is incised and bilateral internal iliac arteries are ligated distally just before the offset of the uterine artery, to avoid collateral re-feeding of the internal iliac artery in case of proximal ligation
broad ligament and ureteric dissection: the base of each broad ligament , both its leaflets and contents are dissected upwards , towards the utero-ovarian vessels away from the uterine lower segment , both ureters are dissected until each ureteric tunnel is identified
, emptying the base of the broad ligament bilaterally helps apply temporary manual circumferencial pressure on cervix in cases of failed conservation and excess bleeding ,
uterine vessels : simple or figure of 8 sutures are applied to each uterine artery and vein on each side incorporating 1 cm wide of the lateral part of the lower segment , this is done just below the placenta or 1 cm above the ureteric tunnel in cases of deep placental invasion .
In cases with extensive broad ligament invasion another high uterine vessels ligation is done to reduce bleeding from the spared utero-ovarian collaterals
posterior uterine wall compression suture : transverse mattress suture is applied at the level of the lower most bulge of the placenta, as low as the levels of the ureteric tunnels
The utero-ovarian anastomosis branches are spared to keep blood flowing to the uterus.
if the bladder was not fully dissected from the anterior uterine wall , now we complete the dissection, noticing the bleeding is less in amount compared to cases we undertake bladder full dissection first before devascularization
anterior uterine wall compression suture : A transverse mattress suture is placed below the placental bulge , incorporating most of the anterior uterine wall tissues , 1 cm medial to each uterine vessel ligatures
, at a corresponding level to the posterior uterine compression suture, while avoiding incorporating the posterior uterine wall to avoid closing the cervical canal
now , we excise the invaded , irreparable anterior wall segment, with the First inch of the incision we notice the uterine incision bleeding , in case the bleeding is low flow & brown in colour in case of proper devascularization, if the bleeding is high flow bright red we revise our ligatures then continue the excision
then separation of the placenta manually
if there's still mild bleeding from the uterine placental bed another full myometrial thickness anterior or posterior uterine wall transverse sutures are applied below or above the placental bed site to control bleeding until it's deemed acceptable
in cases with separate fundal anterior incision, the high incision is repaired in layers first to give more time to compress and monitor the lower segment
refashioning of the Lower segment , repair transversely is usually done, in cases with a wide placental invasion disc excision of a diameter 15-20 cm, if the defect is long we close the incision longitudinally, while maintaining the cervical canal patent at all times
we observe for vaginal bleeding for 20 - 30 minutes intraoperatively before abdominal wall closure
closure over 2 wide bore drains
we continue administration of oxytocin postoperatively
we continue monitoring for vaginal bleeding for the next 24 hours
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
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Conservative surgery for placenta accretta
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Conservative surgery for placenta accretta
Intervention Description
Uterine devasculrization and transverse compressing sutures before placental delivery
Primary Outcome Measure Information:
Title
intraoperative blood loss
Description
Blood loss = estimated blood volume (EBV) x preoperative hematocrit - postoperative hematocrit/preoperative hematocrit another method by weighing the towels and dressings before and after the procedure and adding the volume of fluid inside the suction apparatus
Time Frame
during the operation
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Placenta accreta spectrum, with partial or total invasion With area of invasion more than 7 cm in diameter
patient's informed consent about the future risks of conservative management
pregnancy > 20 weeks
Exclusion Criteria:
* deeply pelvic placenta accreta spectrum cases with cervical invasion , by transvaginal ultrasound cervical length less than 21 mm
cases with total invasion in which the area of invasion is more than 20 min diameter
patient refusing conservative management and opting for hysterectomy
medical comorbidities making massive hemorrhage more likely such as coagulopathies
patient is in active antepartum hemorrhage
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed maged
Organizational Affiliation
Professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kasr Alainy medical school
City
Cairo
ZIP/Postal Code
12111
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Conservative Surgery for Abnormally Invasive Placenta: A New Technique
We'll reach out to this number within 24 hrs