Skip to content

New Conservative Technique for Placenta Accreta Spectrum

Placenta Accreta; A Vision for Conservative Surgery

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04427592
Acronym
percreta
Enrollment
159
Registered
2020-06-11
Start date
2020-07-28
Completion date
2023-05-20
Last updated
2023-12-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Placenta Accreta Spectrum

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.

Interventions

DIAGNOSTIC_TESTultrasound

trans-vaginal and trans-abdominal ultrasound using different modalities such as grey-scale, Doppler, multi-planer mode

PROCEDUREclosure of uterine wall defect

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.

Sponsors

Alexandria University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Investigators conducting prospective study for management of placenta accreta spectrum including diagnosis and uterine sparing surgery.

Eligibility

Sex/Gender
FEMALE
Age
19 Years to 40 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
total operation timeintra-operativethe time taken from the start of the skin incision to the skin closure
manual cervical assesmentbefore skin incisionparticipants were subjected to vaginal examination to asses the cervix lenght
placental separationintra-operativenumber of participants whom their placenta was separated manually
surgical grading of the placentaintra-operativenumber of participants who had accreta, increta, percreta or mixed type
ultrasound grading of the placentapre-operativenumber of participants who were diagnosed by ultrasound as accreta, increta or percreta
manual assessment of vaginal fornicesbefore skin incisionparticipants were subjected to vaginal examination to assess fornices
repair timeintra-operativethe time recorded from the end of the placental separation to the closure of the first layer of the uterus
surgical outcomefrom the time of the surgery until 48 hours after.number of participants whom their uterus were preserved without major hemorrhage
intra-operative blood lossintraoperativethe amount of blood loss during operation was estimated for each participant.
surgical complicationsintraoperativenumber of participants had bladder, ureter injury or hysterectomy,
internal iliac artery ligationintra-operativenumber of participants had with either unilateral or bilateral internal iliac artery ligation
high dependency unit admissionfrom 0 to 48 hours postoperativenumber of participants needed high dependency unit admission
wound complicationsup to 2 weeks postoperativenumber of patients suffered wound infection
change in the hemoglobin levelfrom 48 hours pre operative to 48 hours post operativeparticipant's hemoglobin was measured
blood transfusionfrom 48 hours preoperative to 48 hours postoperative.number of units of blood and it's products transfused to participants
hematuriapost-operative up to 24 hoursnumber of participants suffered hematuria

Secondary

MeasureTime frameDescription
placental bedintra-operativenumber of participants that investigators detected a well delineated placental bed like a pouch
pouch siteintra-operativethe site of the pouch in relation to the cervix
defect siteintra-operativethe location of the myometrium defects

Other

MeasureTime frameDescription
significance of the pouchperi-operativethe investigators determine the relation of the pouch to estimated blood loss
PathologyFrom the operation time for 48 hoursHistopathological examination of 1 cm specimen from the myometriam attached to the placenta in random cases
new ultrasound sign the pouchpre-operativenumber of participants that the investigators detected the previously noticed pouch by ultrasound.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026