New Conservative Technique for Placenta Accreta Spectrum

Placenta Accreta Spectrum Clinical Trial

— percreta  

Official title:

Placenta Accreta; A Vision for Conservative Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04427592
• Other study ID #: H.R501
• Status: Completed
• Phase: N/A
• Start date: July 28, 2020
• Est. completion date: May 20, 2023

Study information

• Verified date: December 2023
• Source: Alexandria University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 159
• Est. completion date: May 20, 2023
• Est. primary completion date: April 20, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 19 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Placenta Accreta
• Placenta Accreta Spectrum

Intervention

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

Procedure:
• closure 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.

Locations

Country	Name	City	State
Egypt	Faculty of Medicine	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
Alexandria University

Country where clinical trial is conducted

Egypt, 

References & Publications (1)

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 Obst — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	new ultrasound sign the pouch	number of participants that the investigators detected the previously noticed pouch by ultrasound.	pre-operative
Other	significance of the pouch	the investigators determine the relation of the pouch to estimated blood loss	peri-operative
Other	Pathology	Histopathological examination of 1 cm specimen from the myometriam attached to the placenta in random cases	From the operation time for 48 hours
Primary	surgical outcome	number of participants whom their uterus were preserved without major hemorrhage	from the time of the surgery until 48 hours after.
Primary	intra-operative blood loss	the amount of blood loss during operation was estimated for each participant.	intraoperative
Primary	surgical complications	number of participants had bladder, ureter injury or hysterectomy,	intraoperative
Primary	internal iliac artery ligation	number of participants had with either unilateral or bilateral internal iliac artery ligation	intra-operative
Primary	high dependency unit admission	number of participants needed high dependency unit admission	from 0 to 48 hours postoperative
Primary	wound complications	number of patients suffered wound infection	up to 2 weeks postoperative
Primary	change in the hemoglobin level	participant's hemoglobin was measured	from 48 hours pre operative to 48 hours post operative
Primary	blood transfusion	number of units of blood and it's products transfused to participants	from 48 hours preoperative to 48 hours postoperative.
Primary	hematuria	number of participants suffered hematuria	post-operative up to 24 hours
Primary	manual cervical assesment	participants were subjected to vaginal examination to asses the cervix lenght	before skin incision
Primary	placental separation	number of participants whom their placenta was separated manually	intra-operative
Primary	surgical grading of the placenta	number of participants who had accreta, increta, percreta or mixed type	intra-operative
Primary	ultrasound grading of the placenta	number of participants who were diagnosed by ultrasound as accreta, increta or percreta	pre-operative
Primary	manual assessment of vaginal fornices	participants were subjected to vaginal examination to assess fornices	before skin incision
Primary	repair time	the time recorded from the end of the placental separation to the closure of the first layer of the uterus	intra-operative
Primary	total operation time	the time taken from the start of the skin incision to the skin closure	intra-operative
Secondary	placental bed	number of participants that investigators detected a well delineated placental bed like a pouch	intra-operative
Secondary	pouch site	the site of the pouch in relation to the cervix	intra-operative
Secondary	defect site	the location of the myometrium defects	intra-operative