Placenta Accreta Spectrum Outcome After Uterine Conservation (PAS)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Placenta Accreta Spectrum
• Intervention / Treatment: Procedure: closure of the uterine wall defect; Diagnostic test: ultrasound; Diagnostic test: outpatient hysteroscopy

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.

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: omar Y Elshorbagy, AS.LEC; Phone Number: 002 01111362322; Email: o_kamal13@alexmed.edu.eg

Study Locations

• Egypt
  • Alexandria, Egypt, 21131
    • Recruiting
    • Faculty of medicine
    • Contact: omar Y Elshorbagy, AS.LEC; Phone Number: 002 01111362322; Email: o_kamal13@alexmed.edu.eg
    • Contact: Omar Y Elshorbagy, AS.LEC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 40 years (Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: pregnant women with placenta accreta spectrum; 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; 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.; Other Names: double compression sutures; 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.; Diagnostic test: 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.; 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

Collaborators and Investigators

• Sponsor: Alexandria University
• Investigators: Study Chair: Mervat S Al-sedik, MD, faculty of medicine department of obstetrics and gyneacology

Study record dates

Study Major Dates

• Study Start (Actual): April 28, 2021
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): March 15, 2026

Study Registration Dates

• First Submitted: April 27, 2021
• First Submitted That Met QC Criteria: April 27, 2021
• First Posted (Actual): April 30, 2021

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 11, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: PAS
• Additional Relevant MeSH Terms: Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Obstetric Labor Complications; Pregnancy Complications; Placenta Diseases; Placenta Accreta
• Other Study ID Numbers: H.R1987

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No