Placenta Accreta Spectrum Outcome After Uterine Conservation

NCT04866888 | Recruiting DMC

• 1 other identifier: H.R1987
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

study will be carried out on patients with placenta accreta spectrum having done uterine conservation and recording immediate outcome of conservation regarding success of the procedure, amount of blood loss and amount of blood transfused and followed up to check the return of menses, any uterine abnormalities by ultrasound or hysteroscopy especially isthmocele and intrauterine synechia.

Conditions

Placenta Accreta Spectrum

Keywords

PAS

Outcome Measures

Primary Outcomes (9)

• date of resumed menses

  calculate the duration from surgery until menses returns

  from 2 weeks to 6 months after surgery

• menstrual abnormalities

  record type of menstrual abnormalities if present such as amenorrhea, oligomenorrhea and dysmenorrhea

  from 2 to 6 months after surgery

• abnormal uterine bleeding

  record the presence of abnormal uterine bleeding after the return of menses such as intermenstrual bleeding, menorrhagia

  from 2 to 6 months after surgery

• pelvic pain

  record the presence of pelvic pain and its duration

  from 2 to 6 months after surgery

• isthmocele

  trans-vaginal and trans-abdominal ultrasound will be done to record the presence of isthmocele, its shape and ratio between residual myometrium and total myometrium

  from 3 to 6 months after surgery

• intrauterine adhesions

  outpatient hysteroscopy will be done to symptomatic patients after consent in order to check uterine cavity recording the presence of intrauterine adhesions, and categorization of adhesions according to american fertility society into mild, moderate and severe

  from 3 to 6 months after surgery

• puerperal blood loss

  recording the duration of blood loss during puerperium and average number of tampons changed per day

  48 hours until 2 months after surgery

• contraception use

  recording method of contraception used

  intraoperative until 5 months after surgery

• fibrosis

  grey scale ultrasound will be done to record size of intra-myometrium fibrosis

  from 3 to 6 months after surgery

Secondary Outcomes (17)

• operation time

  intraoperative

• repair time

  intraoperative

• Estimated blood loss

  intraoperative

• packed red blood cells transfusion

  intraoperative until 24 hours after surgery

• fresh frozen plasma (FFP) transfusion

  intraoperative until 24 hours postoperative

Study Arms (1)

pregnant women with placenta accreta spectrum

EXPERIMENTAL

Bladder will be dissected and mobilized down to the vagina after skeletonization and securing of bridging vessels either by electro-coagulation or ligation. Uterus will be incised 5mm above the placenta bulge, delivering the fetus followed by Carbetocin 100 microgram /1 ml intravascular. Repair of the uterine wall defect will be done. If extrauterine bleeding is excessive we may revert to internal iliac artery ligation followed by insertion of intra-peritoneal drain and regular abdominal wall closure. After 3 months from delivery, ultrasound with different modalities will be done to all patients and outpatient hysteroscopy if symptomatic patients or with abnormal sonography.

Procedure: closure of the uterine wall defect; Diagnostic Test: ultrasound; Diagnostic Test: outpatient hysteroscopy

Interventions

closure of the uterine wall defect PROCEDURE

Uterine exteriorization followed by pealing of amniotic membranes to reach an accessible pole of the placenta to detect a plan of cleavage behind it. The independent hand of the surgeon passed through the previous plan from points of least resistance to high resistance. The defect will be repaired from the inner aspect of the uterus via running sutures using Vicryl (1-0) on a round needle, 45mm. the suture will pass from one edge to hitch the bed and pass to the other edge till we completely close the defect subsequently, controlling the bleeding. Uterine scar closure by running sutures in two layers, where the first layer compresses the placental bed defect externally.

Also known as: double compression sutures

pregnant women with placenta accreta spectrum

ultrasound DIAGNOSTIC_TEST

Before the procedure transabdominal and transvaginal ultrasound will be done to diagnose PAS and to map the uterine wall defects. After 3 months,Transabdominal and transvaginal ultrasound with different modalities to assess the uterine wall, the cavity, endometrium, myometrium and the cervix. Isthmocele will be defined as a defect at uterine wall where residual myometrium thickness and ratio between residual myometrium and total myometrium thickness will be measured and recorded. The shape of the isthmocele will be also recorded.

pregnant women with placenta accreta spectrum

outpatient hysteroscopy DIAGNOSTIC_TEST

Office hysteroscope will be done after patient consent to evaluate the uterine cavity if the patient is symptomatic or with abnormal sonography. It will be performed in the proliferative phase of the menstrual cycle. Non-steroidal anti-inflammatory will be given one hour before the procedure, then the patient will be in lithotomy position. Following aseptic rules, the rigid 4 mm hysteroscope will be inserted into the uterus through the cervix without using speculum nor tenaculum. Any pathology will be identified, and data will be recorded.

Also known as: office hysteroscopy

pregnant women with placenta accreta spectrum

Eligibility Criteria

• Age: 20 Years - 40 Years
• Gender Eligibility Details: pregnant female patient
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Diagnosed sonographically to have placenta accreta spectrum.
• Pregnancy is singleton and fetus is alive.
• Elective caesarean section done from 35 gestational weeks.

You may not qualify if:

• Patients requesting hysterectomy.
• Coexisting uterine pathology such as fibroids or gynaecological malignancies.
• Patients with bleeding diathesis.
• Morbid obesity of BMI \>40.
• Patients having labour pains or vaginal bleeding before scheduled intervention.

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Faculty of Medicine

Alexandria, Alexandria Governorate, 21131, Egypt

RECRUITING

Related Publications (1)

• Elshorbagy OY, Hamdy MA. Conservative surgical repair of placenta increta invading into uterine septum: case report. J Med Case Rep. 2024 Nov 18;18(1):549. doi: 10.1186/s13256-024-04814-7.

  PMID: 39551821 DERIVED

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

• Mervat S Al-sedik, MD

  faculty of medicine department of obstetrics and gyneacology

  STUDY CHAIR

Central Study Contacts

Omar Y Elshorbagy, As.lec

CONTACT

01111362322; o_kamal13@alexmed.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Uterus will be incised 5mm above the placenta bulge. Uterine exteriorization followed by pealing of amniotic membranes to reach an accessible pole of the placenta to detect a plan of cleavage behind it. The independent hand of the surgeon passed through the previous plan from points of least resistance to high resistance. The defect will be repaired from the inner aspect of the uterus via running sutures using Vicryl (1-0) on a round needle, 45mm. the suture will pass from one edge to hitch the bed and pass to the other edge till we completely close the defect subsequently, controlling the bleeding. Uterine scar closure by running sutures in two layers, where the first layer compresses the placental bed defect externally. After 3 months ultrasound and out-patient hysteroscopy will be done to check for any uterine abnormalities

Study Record Dates

• First Submitted: April 27, 2021
• First Posted: April 30, 2021
• Study Start: April 28, 2021
• Primary Completion: December 1, 2025
• Study Completion: March 15, 2026
• Last Updated: February 12, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: after publication for 1 month
• Access Criteria: it will be shared with obstetricians and gynecologists

Locations

EG (1)