Clinical trial NCT04427592: New Conservative Technique for Placenta Accreta Spectrum
Official title: Placenta Accreta; A Vision for Conservative Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Placenta Accreta Spectrum
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2020-06-11
Enrollment: 159
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Investigators conducting prospective study for management of placenta accreta spectrum including diagnosis and uterine sparing surgery.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: surgical outcome
timeFrame: from the time of the surgery until 48 hours after.
measure: intra-operative blood loss
timeFrame: intraoperative
measure: surgical complications
timeFrame: intraoperative
measure: internal iliac artery ligation
timeFrame: intra-operative
measure: high dependency unit admission
timeFrame: from 0 to 48 hours postoperative
measure: wound complications
timeFrame: up to 2 weeks postoperative
measure: change in the hemoglobin level
timeFrame: from 48 hours pre operative to 48 hours post operative
measure: blood transfusion
timeFrame: from 48 hours preoperative to 48 hours postoperative.
measure: hematuria
timeFrame: post-operative up to 24 hours
measure: manual cervical assesment
timeFrame: before skin incision
measure: placental separation
timeFrame: intra-operative
measure: surgical grading of the placenta
timeFrame: intra-operative
measure: ultrasound grading of the placenta
timeFrame: pre-operative
measure: manual assessment of vaginal fornices
timeFrame: before skin incision
measure: repair time
timeFrame: intra-operative
measure: total operation time
timeFrame: intra-operative
Secondary outcomes:
measure: placental bed
timeFrame: intra-operative
measure: pouch site
timeFrame: intra-operative
measure: defect site
timeFrame: intra-operative
Other outcomes:
measure: new ultrasound sign the pouch
timeFrame: pre-operative
measure: significance of the pouch
timeFrame: peri-operative
measure: Pathology
timeFrame: From the operation time for 48 hours
Locations:
city: Alexandria
country: Egypt
facility: Faculty of Medicine
Study officials:
affiliation: faculty of medicine department of obstetrics and gyneacology
name: Mahmoud AH Hamdy, A. lecturer
role: PRINCIPAL_INVESTIGATOR
References:
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.