Placenta Accreta Spectrum
Conditions
Keywords
PAS
Brief 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.
Detailed 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.
Interventions
PROCEDUREclosure 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_TESTultrasound
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.
DIAGNOSTIC_TESToutpatient 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.
Sponsors
Alexandria University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Uterus will be incised 5mm above the placenta bulge. 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. After 3 months ultrasound and out-patient hysteroscopy will be done to check for any uterine abnormalities
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| urine output | intraoperative | recording amount of urine output |
| internal iliac artery ligation | intraoperative | recording if the internal iliac artery ligated whether it was unilateral or bilateral |
| pre-operative hemoglobin | preoperative | recording amount of hemoglobin |
| post-operative hemoglobin | postoperative within 6 hours from surgery | recording amount of hemoglobin |
| operation time | intraoperative | recording total time of the surgery |
| ICU admission | immediate postoperative until 5 days after surgery | recording the number of patients admitted to the ICU |
| intermediate care admission | recording the number of patients admitted to the ICU | recording the number of patients admitted to the intermediate care |
| surgical diagnosis | intraoperative | document the type of placenta accreta spectrum whether it is accreta, increta or percreta and area of the uterus where the placental invade |
| hospital stay | postoperative until 10 days after surgery | recording duration of hospital stay after surgery |
| repair time | intraoperative | recording length of defect repair from placental separation until uterine wall closure |
| Estimated blood loss | intraoperative | recording amount of blood loss |
| packed red blood cells transfusion | intraoperative until 24 hours after surgery | recording amount of red blood cell transfused |
| fresh frozen plasma (FFP) transfusion | intraoperative until 24 hours postoperative | recording amount of FFP transfusion |
| bladder injury | intraoperative until 2 weeks post operative | recording if there was an injury to the bladder |
| ureter injury | intraoperative until 2 weeks post operative | recording if there was an injury to the ureter |
| bowel injury | intraoperative until 2 weeks post operative | recording if there was an injury to the bowel |
| surgical site infection | 24 hours until 1 month after surgery | record the presence of wound infection |
Countries
Egypt
Contacts
Primary ContactOmar Y Elshorbagy, As.lec
Outcome results
None listed