New Conservative Technique for Placenta Accreta Spectrum (percreta)

Placenta Accreta; A Vision for Conservative Surgery

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.

Study Overview

• Status: Completed
• Conditions: Placenta Accreta Spectrum
• Intervention / Treatment: Diagnostic test: ultrasound; Procedure: closure of uterine wall defect

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 Type: Interventional
• Enrollment (Actual): 159
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Alexandria, Egypt, 21131
    • Faculty of medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 40 years (Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: pregnant women with placenta accreta spectrum; The participants were subjected to ultrasound to diagnose placenta accreta spectrum followed by new conservative surgical technique.

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.; Other Names: Double compression suture

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
new ultrasound sign the pouch	number of participants that the investigators detected the previously noticed pouch by ultrasound.	pre-operative
significance of the pouch	the investigators determine the relation of the pouch to estimated blood loss	peri-operative
Pathology	Histopathological examination of 1 cm specimen from the myometriam attached to the placenta in random cases	From the operation time for 48 hours

Collaborators and Investigators

• Sponsor: Alexandria University
• Investigators: Principal Investigator: Mahmoud AH Hamdy, A. lecturer, faculty of medicine department of obstetrics and gyneacology

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 28, 2020
• Primary Completion (Actual): April 20, 2023
• Study Completion (Actual): May 20, 2023

Study Registration Dates

• First Submitted: May 31, 2020
• First Submitted That Met QC Criteria: June 9, 2020
• First Posted (Actual): June 11, 2020

Study Record Updates

• Last Update Posted (Actual): December 6, 2023
• Last Update Submitted That Met QC Criteria: December 4, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Placenta Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Placenta Accreta
• Other Study ID Numbers: H.R501

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: all IPD that underlies results in publication
• IPD Sharing Time Frame: after publication by 1 month
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No