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Recruiting Not applicable

Placenta Accreta Spectrum Outcome After Uterine Conservation

NCT04866888 · tracked via the Priya Life Science Egypt tracker
Phase
Not applicable
Started
2021-04-28
Last updated
2025-02-12

Condition(s) studied

Placenta Accreta Spectrum

Investigational drug(s) / intervention(s)

closure of the uterine wall defectultrasoundoutpatient hysteroscopy

closure of the uterine wall defect: 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.

ultrasound: 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.

outpatient hysteroscopy: 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.

Study 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.

Eligibility

Sex
FEMALE
Min age
20 Years
Max age
40 Years
Healthy volunteers
No
Inclusion Criteria: * • Diagnosed sonographically to have placenta accreta spectrum. * Pregnancy is singleton and fetus is alive. * Elective caesarean section done from 35 gestational weeks. Exclusion Criteria: * • 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.

Primary outcome measure(s)

  • date of resumed menses — from 2 weeks to 6 months after surgery
    calculate the duration from surgery until menses returns
  • menstrual abnormalities — from 2 to 6 months after surgery
    record type of menstrual abnormalities if present such as amenorrhea, oligomenorrhea and dysmenorrhea
  • abnormal uterine bleeding — from 2 to 6 months after surgery
    record the presence of abnormal uterine bleeding after the return of menses such as intermenstrual bleeding, menorrhagia
  • pelvic pain — from 2 to 6 months after surgery
    record the presence of pelvic pain and its duration
  • isthmocele — from 3 to 6 months after surgery
    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
  • intrauterine adhesions — from 3 to 6 months after surgery
    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
  • puerperal blood loss — 48 hours until 2 months after surgery
    recording the duration of blood loss during puerperium and average number of tampons changed per day
  • contraception use — intraoperative until 5 months after surgery
    recording method of contraception used
  • fibrosis — from 3 to 6 months after surgery
    grey scale ultrasound will be done to record size of intra-myometrium fibrosis

Trial sites (1)

FacilityCityRegionStatus
Faculty of Medicine Alexandria Alexandria Governorate Recruiting

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04866888 on ClinicalTrials.gov ↗ ← All trials in Egypt