Faculty of Medicine
Alexandria, Alexandria Governorate, 21131, Egypt
Location status: Recruiting
Location contact
Omar Y Elshorbagy, AS.LEC
PRINCIPAL_INVESTIGATOR
omar Y Elshorbagy, AS.LEC
CONTACT
01111362322 ext. 002
NCT Number: NCT04866888
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.
Interested in participating?
Request Info20 year–40 year
Female
Interventional
Not applicable
Alexandria, Alexandria Governorate, 21131, Egypt
Location status: Recruiting
Omar Y Elshorbagy, AS.LEC
PRINCIPAL_INVESTIGATOR
omar Y Elshorbagy, AS.LEC
CONTACT
01111362322 ext. 002
After institutional review board approval and written informed consent, recruited cases will be subjected to the following:
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: 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.
Other names: office hysteroscopy
Time frame: from 2 weeks to 6 months after surgery
calculate the duration from surgery until menses returns
Time frame: from 2 to 6 months after surgery
record type of menstrual abnormalities if present such as amenorrhea, oligomenorrhea and dysmenorrhea
Time frame: from 2 to 6 months after surgery
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
record the presence of pelvic pain and its duration
Time frame: 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
Time frame: 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
Time frame: 48 hours until 2 months after surgery
recording the duration of blood loss during puerperium and average number of tampons changed per day
Time frame: intraoperative until 5 months after surgery
recording method of contraception used
Time frame: from 3 to 6 months after surgery
grey scale ultrasound will be done to record size of intra-myometrium fibrosis
Time frame: intraoperative
recording total time of the surgery
Time frame: intraoperative
recording length of defect repair from placental separation until uterine wall closure
Time frame: intraoperative
recording amount of blood loss
Time frame: intraoperative until 24 hours after surgery
recording amount of red blood cell transfused
Time frame: intraoperative until 24 hours postoperative
recording amount of FFP transfusion
Time frame: intraoperative until 2 weeks post operative
recording if there was an injury to the bladder
Time frame: intraoperative until 2 weeks post operative
recording if there was an injury to the ureter
Time frame: intraoperative until 2 weeks post operative
recording if there was an injury to the bowel
Time frame: 24 hours until 1 month after surgery
record the presence of wound infection
Time frame: intraoperative
recording amount of urine output
Time frame: intraoperative
recording if the internal iliac artery ligated whether it was unilateral or bilateral
Time frame: preoperative
recording amount of hemoglobin
Time frame: postoperative within 6 hours from surgery
recording amount of hemoglobin
Time frame: postoperative until 10 days after surgery
recording duration of hospital stay after surgery
Time frame: immediate postoperative until 5 days after surgery
recording the number of patients admitted to the ICU
Time frame: recording the number of patients admitted to the ICU
recording the number of patients admitted to the intermediate care
Time frame: intraoperative
document the type of placenta accreta spectrum whether it is accreta, increta or percreta and area of the uterus where the placental invade
Contact information is provided by the study sponsor or research team.
Alexandria University
Other
Short and Intermediate Term Outcomes of Uterine Conservation After Cesarian Section in Cases of Placenta Accreta Spectrum
Acronym: PAS
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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