An interventional study of closure of the uterine wall defect and ultrasound in Placenta Accreta Spectrum, sponsored by Alexandria University. Recruiting at 1 site in Egypt. Open to female participants aged 20 Years to 40 Years. Per ClinicalTrials.gov, last updated 2025-02-12.
Sponsored by Alexandria University · Not applicable, Interventional, and Treatment
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.
After institutional review board approval and written informed consent, recruited cases will be subjected to the following:
Data registration including:
Intraoperative details will be documented. Follow up of patients will be recorded. Sample size was calculated by estimating a single proportion distribution at a significance level of 0.05.
149 studies on the registry are indexed under Placenta Accreta; 40 are open to participants now.
This study's planned enrollment of 120 is above the median of 63 across 64 interventional studies indexed under Placenta Accreta.
Browse Placenta Accreta studies →Alexandria University is the lead sponsor of 586 studies on the registry; 127 are open to participants now.
Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Diagnosed sonographically to have placenta accreta spectrum.
Exclusion Criteria:
Patients requesting hysterectomy.
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
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
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.
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
date of resumed menses
calculate the duration from surgery until menses returns
Time frame: from 2 weeks to 6 months after surgery
menstrual abnormalities
record type of menstrual abnormalities if present such as amenorrhea, oligomenorrhea and dysmenorrhea
Time frame: 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
Time frame: from 2 to 6 months after surgery
pelvic pain
record the presence of pelvic pain and its duration
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 48 hours until 2 months after surgery
contraception use
recording method of contraception used
Time frame: intraoperative until 5 months after surgery
fibrosis
grey scale ultrasound will be done to record size of intra-myometrium fibrosis
Time frame: from 3 to 6 months after surgery
operation time
recording total time of the surgery
Time frame: intraoperative
repair time
recording length of defect repair from placental separation until uterine wall closure
Time frame: intraoperative
Estimated blood loss
recording amount of blood loss
Time frame: intraoperative
packed red blood cells transfusion
recording amount of red blood cell transfused
Time frame: intraoperative until 24 hours after surgery
fresh frozen plasma (FFP) transfusion
recording amount of FFP transfusion
Time frame: intraoperative until 24 hours postoperative
bladder injury
recording if there was an injury to the bladder
Time frame: intraoperative until 2 weeks post operative
ureter injury
recording if there was an injury to the ureter
Time frame: intraoperative until 2 weeks post operative
bowel injury
recording if there was an injury to the bowel
Time frame: intraoperative until 2 weeks post operative
surgical site infection
record the presence of wound infection
Time frame: 24 hours until 1 month after surgery
urine output
recording amount of urine output
Time frame: intraoperative
internal iliac artery ligation
recording if the internal iliac artery ligated whether it was unilateral or bilateral
Time frame: intraoperative
pre-operative hemoglobin
recording amount of hemoglobin
Time frame: preoperative
post-operative hemoglobin
recording amount of hemoglobin
Time frame: postoperative within 6 hours from surgery
hospital stay
recording duration of hospital stay after surgery
Time frame: postoperative until 10 days after surgery
ICU admission
recording the number of patients admitted to the ICU
Time frame: immediate postoperative until 5 days after surgery
intermediate care admission
recording the number of patients admitted to the intermediate care
Time frame: recording the number of patients admitted to the ICU
surgical diagnosis
document the type of placenta accreta spectrum whether it is accreta, increta or percreta and area of the uterus where the placental invade
Time frame: intraoperative
Plan to share: Yes — all individual patient data (IPD) that underlies results in publication
Supporting information: Study protocol, Statistical analysis plan
Time frame: after publication for 1 month
Access criteria: it will be shared with obstetricians and gynecologists
Started Apr 2021 (actual). Primary completion is estimated for Dec 2025, 55 months after the start.
Of 44 non-industry interventional studies with no phase under Placenta Accreta, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 41. This study's planned 55 months is above that.
Counting every sponsor, half of 44 studies reached it within 18 months; a quarter within 12 and three quarters within 41.
How these figures are worked out, and which studies are left out of them.
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