New Conservative Technique for Placenta Accreta Spectrum

NCT04427592 | Completed DMC

• 1 other identifier: H.R501
• Study Type: interventional
• Target: 159
• Locations: 1 country
• Sites: 1

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.

Conditions

Placenta Accreta Spectrum

Outcome Measures

Primary Outcomes (16)

• 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 Outcomes (3)

• placental bed

  intra-operative

• pouch site

  intra-operative

• defect site

  intra-operative

Other Outcomes (3)

• new ultrasound sign the pouch

  pre-operative

• significance of the pouch

  peri-operative

• Pathology

  From the operation time for 48 hours

Study Arms (1)

pregnant women with placenta accreta spectrum

EXPERIMENTAL

The participants were subjected to ultrasound to diagnose placenta accreta spectrum followed by new conservative surgical technique.

Diagnostic Test: ultrasound; Procedure: closure of uterine wall defect

Interventions

ultrasound DIAGNOSTIC_TEST

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

pregnant women with placenta accreta spectrum

closure of uterine wall defect PROCEDURE

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.

Also known as: Double compression suture

pregnant women with placenta accreta spectrum

Eligibility Criteria

• Age: 19 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• pregnant women diagnosed as placenta accreta spectrum with previous Cesarean section, with or without other uterine surgeries and less than 40 years of age.

You may not qualify if:

• 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

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Faculty of Medicine

Alexandria, 21131, Egypt

Location

Related 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 Obstet. 2018 Mar;140(3):291-298. doi: 10.1002/ijgo.12410. No abstract available.

  PMID: 29405320 RESULT

MeSH Terms

Conditions

Placenta Accreta

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Placenta Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Mahmoud AH Hamdy, A. lecturer

  faculty of medicine department of obstetrics and gyneacology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

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

Study Record Dates

• First Submitted: May 31, 2020
• First Posted: June 11, 2020
• Study Start: July 28, 2020
• Primary Completion: April 20, 2023
• Study Completion: May 20, 2023
• Last Updated: December 6, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: after publication by 1 month

Locations

EG (1)