New Conservative Technique for Placenta Accreta Spectrum

Not Applicable

Completed

• Conditions: Placenta Accreta Spectrum
• Interventions: Diagnostic Test: ultrasound; Procedure: closure of uterine wall defect

• Registration Number: NCT04427592
• Lead Sponsor: Alexandria University

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.

Study Timeline

• Study First Submitted: 2020-05-31
• Study First Submitted QC: 2020-06-09
• Study First Posted: 2020-06-11
• Study Start: 2020-07-28
• Primary Completion: 2023-04-20
• Study Completion: 2023-05-20
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-04
• Last Update Posted: 2023-12-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 159

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
pregnant women with placenta accreta spectrum	ultrasound	The participants were subjected to ultrasound to diagnose placenta accreta spectrum followed by new conservative surgical technique.
pregnant women with placenta accreta spectrum	closure of uterine wall defect	The participants were subjected to ultrasound to diagnose placenta accreta spectrum followed by new conservative surgical technique.

Primary Outcome Measures

Name	Time	Method
blood transfusion	from 48 hours preoperative to 48 hours postoperative.	number of units of blood and it's products transfused to participants
hematuria	post-operative up to 24 hours	number of participants suffered hematuria
manual cervical assesment	before skin incision	participants were subjected to vaginal examination to asses the cervix lenght
placental separation	intra-operative	number of participants whom their placenta was separated manually
wound complications	up to 2 weeks postoperative	number of patients suffered wound infection
change in the hemoglobin level	from 48 hours pre operative to 48 hours post operative	participant's hemoglobin was measured
high dependency unit admission	from 0 to 48 hours postoperative	number of participants needed high dependency unit admission
surgical grading of the placenta	intra-operative	number of participants who had accreta, increta, percreta or mixed type
manual assessment of vaginal fornices	before skin incision	participants were subjected to vaginal examination to assess fornices
surgical outcome	from the time of the surgery until 48 hours after.	number of participants whom their uterus were preserved without major hemorrhage
intra-operative blood loss	intraoperative	the amount of blood loss during operation was estimated for each participant.
surgical complications	intraoperative	number of participants had bladder, ureter injury or hysterectomy,
internal iliac artery ligation	intra-operative	number of participants had with either unilateral or bilateral internal iliac artery ligation
ultrasound grading of the placenta	pre-operative	number of participants who were diagnosed by ultrasound as accreta, increta or percreta
repair time	intra-operative	the time recorded from the end of the placental separation to the closure of the first layer of the uterus
total operation time	intra-operative	the time taken from the start of the skin incision to the skin closure

Secondary Outcome Measures

Name	Time	Method
defect site	intra-operative	the location of the myometrium defects
placental bed	intra-operative	number of participants that investigators detected a well delineated placental bed like a pouch
pouch site	intra-operative	the site of the pouch in relation to the cervix

Trial Locations

Locations (1)

Faculty of Medicine; 🇪🇬 Alexandria, Egypt