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Placenta Accreta Spectrum Outcome After Uterine Conservation (PAS)

Primary Purpose

Placenta Accreta Spectrum

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
closure of the uterine wall defect
ultrasound
outpatient hysteroscopy
Sponsored by
Alexandria University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Placenta Accreta Spectrum focused on measuring PAS

Eligibility Criteria

20 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Faculty of MedicineRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

pregnant women with placenta accreta spectrum

Arm Description

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.

Outcomes

Primary Outcome Measures

date of resumed menses
calculate the duration from surgery until menses returns
menstrual abnormalities
record type of menstrual abnormalities if present such as amenorrhea, oligomenorrhea and dysmenorrhea
abnormal uterine bleeding
record the presence of abnormal uterine bleeding after the return of menses such as intermenstrual bleeding, menorrhagia
pelvic pain
record the presence of pelvic pain and its duration
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
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
puerperal blood loss
recording the duration of blood loss during puerperium and average number of tampons changed per day
contraception use
recording method of contraception used
fibrosis
grey scale ultrasound will be done to record size of intra-myometrium fibrosis

Secondary Outcome Measures

operation time
recording total time of the surgery
repair time
recording length of defect repair from placental separation until uterine wall closure
Estimated blood loss
recording amount of blood loss
packed red blood cells transfusion
recording amount of red blood cell transfused
fresh frozen plasma (FFP) transfusion
recording amount of FFP transfusion
bladder injury
recording if there was an injury to the bladder
ureter injury
recording if there was an injury to the ureter
bowel injury
recording if there was an injury to the bowel
surgical site infection
record the presence of wound infection
urine output
recording amount of urine output
internal iliac artery ligation
recording if the internal iliac artery ligated whether it was unilateral or bilateral
pre-operative hemoglobin
recording amount of hemoglobin
post-operative hemoglobin
recording amount of hemoglobin
hospital stay
recording duration of hospital stay after surgery
ICU admission
recording the number of patients admitted to the ICU
intermediate care admission
recording the number of patients admitted to the intermediate care
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

Full Information

First Posted
April 27, 2021
Last Updated
October 16, 2023
Sponsor
Alexandria University
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1. Study Identification

Unique Protocol Identification Number
NCT04866888
Brief Title
Placenta Accreta Spectrum Outcome After Uterine Conservation
Acronym
PAS
Official Title
Short and Intermediate Term Outcomes of Uterine Conservation After Cesarian Section in Cases of Placenta Accreta Spectrum
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 28, 2021 (Actual)
Primary Completion Date
March 1, 2024 (Anticipated)
Study Completion Date
July 15, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alexandria University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Placenta Accreta Spectrum
Keywords
PAS

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
pregnant women with placenta accreta spectrum
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
closure of the uterine wall defect
Other Intervention Name(s)
double compression sutures
Intervention Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
ultrasound
Intervention Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
outpatient hysteroscopy
Other Intervention Name(s)
office hysteroscopy
Intervention Description
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.
Primary Outcome Measure Information:
Title
date of resumed menses
Description
calculate the duration from surgery until menses returns
Time Frame
from 2 weeks to 6 months after surgery
Title
menstrual abnormalities
Description
record type of menstrual abnormalities if present such as amenorrhea, oligomenorrhea and dysmenorrhea
Time Frame
from 2 to 6 months after surgery
Title
abnormal uterine bleeding
Description
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
Title
pelvic pain
Description
record the presence of pelvic pain and its duration
Time Frame
from 2 to 6 months after surgery
Title
isthmocele
Description
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
Title
intrauterine adhesions
Description
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
from 3 to 6 months after surgery
Title
puerperal blood loss
Description
recording the duration of blood loss during puerperium and average number of tampons changed per day
Time Frame
48 hours until 2 months after surgery
Title
contraception use
Description
recording method of contraception used
Time Frame
intraoperative until 5 months after surgery
Title
fibrosis
Description
grey scale ultrasound will be done to record size of intra-myometrium fibrosis
Time Frame
from 3 to 6 months after surgery
Secondary Outcome Measure Information:
Title
operation time
Description
recording total time of the surgery
Time Frame
intraoperative
Title
repair time
Description
recording length of defect repair from placental separation until uterine wall closure
Time Frame
intraoperative
Title
Estimated blood loss
Description
recording amount of blood loss
Time Frame
intraoperative
Title
packed red blood cells transfusion
Description
recording amount of red blood cell transfused
Time Frame
intraoperative until 24 hours after surgery
Title
fresh frozen plasma (FFP) transfusion
Description
recording amount of FFP transfusion
Time Frame
intraoperative until 24 hours postoperative
Title
bladder injury
Description
recording if there was an injury to the bladder
Time Frame
intraoperative until 2 weeks post operative
Title
ureter injury
Description
recording if there was an injury to the ureter
Time Frame
intraoperative until 2 weeks post operative
Title
bowel injury
Description
recording if there was an injury to the bowel
Time Frame
intraoperative until 2 weeks post operative
Title
surgical site infection
Description
record the presence of wound infection
Time Frame
24 hours until 1 month after surgery
Title
urine output
Description
recording amount of urine output
Time Frame
intraoperative
Title
internal iliac artery ligation
Description
recording if the internal iliac artery ligated whether it was unilateral or bilateral
Time Frame
intraoperative
Title
pre-operative hemoglobin
Description
recording amount of hemoglobin
Time Frame
preoperative
Title
post-operative hemoglobin
Description
recording amount of hemoglobin
Time Frame
postoperative within 6 hours from surgery
Title
hospital stay
Description
recording duration of hospital stay after surgery
Time Frame
postoperative until 10 days after surgery
Title
ICU admission
Description
recording the number of patients admitted to the ICU
Time Frame
immediate postoperative until 5 days after surgery
Title
intermediate care admission
Description
recording the number of patients admitted to the intermediate care
Time Frame
recording the number of patients admitted to the ICU
Title
surgical diagnosis
Description
document the type of placenta accreta spectrum whether it is accreta, increta or percreta and area of the uterus where the placental invade
Time Frame
intraoperative

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
pregnant female patient
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Omar Y Elshorbagy, As.lec
Phone
01111362322
Ext
002
Email
o_kamal13@alexmed.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mervat S Al-sedik, MD
Organizational Affiliation
faculty of medicine department of obstetrics and gyneacology
Official's Role
Study Chair
Facility Information:
Facility Name
Faculty of Medicine
City
Alexandria
ZIP/Postal Code
21131
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
omar Y Elshorbagy, AS.LEC
Phone
01111362322
Ext
002
Email
o_kamal13@alexmed.edu.eg
First Name & Middle Initial & Last Name & Degree
Omar Y Elshorbagy, AS.LEC

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
all individual patient data (IPD) that underlies results in publication
IPD Sharing Time Frame
after publication for 1 month
IPD Sharing Access Criteria
it will be shared with obstetricians and gynecologists

Learn more about this trial

Placenta Accreta Spectrum Outcome After Uterine Conservation

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