Placenta Accreta Spectrum Outcome After Uterine Conservation

Placenta Accreta Spectrum Clinical Trial

— PAS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04866888
• Other study ID #: H.R1987
• Status: Recruiting
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Placenta Accreta
• Placenta Accreta Spectrum

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