Placenta Accreta Spectrum Outcome After Uterine Conservation

Study Overview
=================
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: 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. Anthropometry including weight, height, and body mass index (BMI) before pregnancy and at the time of operation. General examination including vital signs, and signs of any associated problems. Routine laboratory investigations with particular emphasis on complete blood count, Coagulation profile and including blood glucose level, renal and liver function tests. 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.

Official Title
-----------------
Short and Intermediate Term Outcomes of Uterine Conservation After Cesarian Section in Cases of Placenta Accreta Spectrum

Conditions
-----------------
Placenta Accreta Spectrum

Intervention / Treatment
-----------------
* Procedure: closure of the uterine wall defect
* Diagnostic Test: ultrasound
* Diagnostic Test: outpatient hysteroscopy


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional 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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: pregnant women with placenta accreta spectrum<br>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<br>* 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.<br>* Other names: double compression sutures;Diagnostic Test: ultrasound<br>* 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.<br>Diagnostic Test: outpatient hysteroscopy<br>* 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.<br>* Other names: office hysteroscopy;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| date of resumed menses | calculate the duration from surgery until menses returns | from 2 weeks to 6 months after surgery | 
| menstrual abnormalities | record type of menstrual abnormalities if present such as amenorrhea, oligomenorrhea and dysmenorrhea | 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 | from 2 to 6 months after surgery | 
| pelvic pain | record the presence of pelvic pain and its duration | 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 | 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 | 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 | 48 hours until 2 months after surgery | 
| contraception use | recording method of contraception used | intraoperative until 5 months after surgery | 
| fibrosis | grey scale ultrasound will be done to record size of intra-myometrium fibrosis | from 3 to 6 months after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| operation time | recording total time of the surgery | intraoperative | 
| repair time | recording length of defect repair from placental separation until uterine wall closure | intraoperative | 
| Estimated blood loss | recording amount of blood loss | intraoperative | 
| packed red blood cells transfusion | recording amount of red blood cell transfused | intraoperative until 24 hours after surgery | 
| fresh frozen plasma (FFP) transfusion | recording amount of FFP transfusion | intraoperative until 24 hours postoperative | 
| bladder injury | recording if there was an injury to the bladder | intraoperative until 2 weeks post operative | 
| ureter injury | recording if there was an injury to the ureter | intraoperative until 2 weeks post operative | 
| bowel injury | recording if there was an injury to the bowel | intraoperative until 2 weeks post operative | 
| surgical site infection | record the presence of wound infection | 24 hours until 1 month after surgery | 
| urine output | recording amount of urine output | intraoperative | 
| internal iliac artery ligation | recording if the internal iliac artery ligated whether it was unilateral or bilateral | intraoperative | 
| pre-operative hemoglobin | recording amount of hemoglobin | preoperative | 
| post-operative hemoglobin | recording amount of hemoglobin | postoperative within 6 hours from surgery | 
| hospital stay | recording duration of hospital stay after surgery | postoperative until 10 days after surgery | 
| ICU admission | recording the number of patients admitted to the ICU | immediate postoperative until 5 days after surgery | 
| intermediate care admission | recording the number of patients admitted to the intermediate care | 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 | intraoperative | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PAS