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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04866888
Other study ID # H.R1987
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date April 28, 2021
Est. completion date July 15, 2024

Study information

Verified date September 2023
Source Alexandria University
Contact Omar Y Elshorbagy, As.lec
Phone 01111362322
Email o_kamal13@alexmed.edu.eg
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

After institutional review board approval and written informed consent, recruited cases will be subjected to the following: 1. Data registration including: - Age. - Obstetric history including gravidity, parity, number of previous cesarean deliveries, and number and gender of living children. - Details of the current pregnancy including duration in menstrual weeks, any problems encountered during its course. - Desire for future fertility. - Medical, surgical, and medication history. 2. Anthropometry including weight, height, and body mass index (BMI) before pregnancy and at the time of operation. 3. General examination including vital signs, and signs of any associated problems. 4. Routine laboratory investigations with particular emphasis on complete blood count, Coagulation profile and including blood glucose level, renal and liver function tests. 5. Detailed sonographic examination to evaluate fetal biometry, and wellbeing rule out exclusion factors, and confirm diagnosis of PAS and assess the degree of invasion, and its severity using both trans-abdominal transducer with frequency of 2-5 megahertz (MHZ) and trans-vaginal transducer with frequency of 4-10 MHZ. 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 120
Est. completion date July 15, 2024
Est. primary completion date March 1, 2024
Accepts healthy volunteers No
Gender Female
Age group 20 Years to 40 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
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.
Diagnostic Test:
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.

Locations

Country Name City State
Egypt Faculty of Medicine Alexandria

Sponsors (1)

Lead Sponsor Collaborator
Alexandria University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary date of resumed menses calculate the duration from surgery until menses returns from 2 weeks to 6 months after surgery
Primary menstrual abnormalities record type of menstrual abnormalities if present such as amenorrhea, oligomenorrhea and dysmenorrhea from 2 to 6 months after surgery
Primary 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
Primary pelvic pain record the presence of pelvic pain and its duration from 2 to 6 months after surgery
Primary 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
Primary 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
Primary 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
Primary contraception use recording method of contraception used intraoperative until 5 months after surgery
Primary fibrosis grey scale ultrasound will be done to record size of intra-myometrium fibrosis from 3 to 6 months after surgery
Secondary operation time recording total time of the surgery intraoperative
Secondary repair time recording length of defect repair from placental separation until uterine wall closure intraoperative
Secondary Estimated blood loss recording amount of blood loss intraoperative
Secondary packed red blood cells transfusion recording amount of red blood cell transfused intraoperative until 24 hours after surgery
Secondary fresh frozen plasma (FFP) transfusion recording amount of FFP transfusion intraoperative until 24 hours postoperative
Secondary bladder injury recording if there was an injury to the bladder intraoperative until 2 weeks post operative
Secondary ureter injury recording if there was an injury to the ureter intraoperative until 2 weeks post operative
Secondary bowel injury recording if there was an injury to the bowel intraoperative until 2 weeks post operative
Secondary surgical site infection record the presence of wound infection 24 hours until 1 month after surgery
Secondary urine output recording amount of urine output intraoperative
Secondary internal iliac artery ligation recording if the internal iliac artery ligated whether it was unilateral or bilateral intraoperative
Secondary pre-operative hemoglobin recording amount of hemoglobin preoperative
Secondary post-operative hemoglobin recording amount of hemoglobin postoperative within 6 hours from surgery
Secondary hospital stay recording duration of hospital stay after surgery postoperative until 10 days after surgery
Secondary ICU admission recording the number of patients admitted to the ICU immediate postoperative until 5 days after surgery
Secondary intermediate care admission recording the number of patients admitted to the intermediate care recording the number of patients admitted to the ICU
Secondary 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 intraoperative
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