Placenta Accreta Spectrum Outcome After Uterine Conservation
Condition(s) studied
Investigational drug(s) / intervention(s)
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
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)
| Facility | City | Region | Status |
|---|---|---|---|
| Faculty of Medicine | Alexandria | Alexandria Governorate | Recruiting |
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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