Placenta Accreta SpectrumPASNCT04866888
Placenta Accreta Spectrum Outcome After Uterine Conservation
A study testing closure of the uterine wall defect, ultrasound and outpatient hysteroscopy in people with Placenta Accreta Spectrum, run by Alexandria University at 1 site in Egypt.
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… Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Placenta Accreta Spectrum
- What is being tested?
- closure of the uterine wall defect, ultrasound and outpatient hysteroscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 28 Apr 2021to 15 Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- • Diagnosed sonographically to have placenta accreta spectrum.
- Pregnancy is singleton and fetus is alive.
- Elective caesarean section done from 35 gestational weeks.
Who cannot join
- • 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Medicine
Alexandria, Alexandria Governorate, 21131
omar Y Elshorbagy, AS.LEC, 01111362322 ext. 002, o_kamal13@alexmed.edu.eg
Omar Y Elshorbagy, AS.LEC
About this study
Official title: 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.
Read the 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.
- Conditions
- Placenta Accreta Spectrum
- Being tested
- closure of the uterine wall defect, ultrasound, outpatient hysteroscopy
- Keywords
- PAS
- Medical subject headings
- Placenta Accreta
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
closure of the uterine wall defectProcedure or surgery
Also called double compression sutures
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.
ultrasoundDiagnostic test
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 hysteroscopyDiagnostic test
Also called office 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.
| Study group | Role | What they receive |
|---|---|---|
| pregnant women with placenta accreta spectrum | Experimental | 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. Receives: Procedure: closure of the uterine wall defect; Diagnostic Test: ultrasound; Diagnostic Test: outpatient hysteroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
date of resumed menses
calculate the duration from surgery until menses returns
Measured: from 2 weeks to 6 months after surgery
menstrual abnormalities
record type of menstrual abnormalities if present such as amenorrhea, oligomenorrhea and dysmenorrhea
Measured: 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
Measured: from 2 to 6 months after surgery
pelvic pain
record the presence of pelvic pain and its duration
Measured: 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
Measured: 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
Measured: 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
Measured: 48 hours until 2 months after surgery
contraception use
recording method of contraception used
Measured: intraoperative until 5 months after surgery
fibrosis
grey scale ultrasound will be done to record size of intra-myometrium fibrosis
Measured: from 3 to 6 months after surgery
Secondary outcomes (17)
operation time
recording total time of the surgery
Measured: intraoperative
repair time
recording length of defect repair from placental separation until uterine wall closure
Measured: intraoperative
Estimated blood loss
recording amount of blood loss
Measured: intraoperative
packed red blood cells transfusion
recording amount of red blood cell transfused
Measured: intraoperative until 24 hours after surgery
fresh frozen plasma (FFP) transfusion
recording amount of FFP transfusion
Measured: intraoperative until 24 hours postoperative
bladder injury
recording if there was an injury to the bladder
Measured: intraoperative until 2 weeks post operative
ureter injury
recording if there was an injury to the ureter
Measured: intraoperative until 2 weeks post operative
bowel injury
recording if there was an injury to the bowel
Measured: intraoperative until 2 weeks post operative
surgical site infection
record the presence of wound infection
Measured: 24 hours until 1 month after surgery
urine output
recording amount of urine output
Measured: intraoperative
internal iliac artery ligation
recording if the internal iliac artery ligated whether it was unilateral or bilateral
Measured: intraoperative
pre-operative hemoglobin
recording amount of hemoglobin
Measured: preoperative
post-operative hemoglobin
recording amount of hemoglobin
Measured: postoperative within 6 hours from surgery
hospital stay
recording duration of hospital stay after surgery
Measured: postoperative until 10 days after surgery
ICU admission
recording the number of patients admitted to the ICU
Measured: immediate postoperative until 5 days after surgery
intermediate care admission
recording the number of patients admitted to the intermediate care
Measured: 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
Measured: intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2021
- Study start28 Apr 2021
- Primary completion1 Dec 2025 (estimated)
- Study completion15 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Placenta Accreta SpectrumStudies of the same condition, open and under way.
- More trials run by Alexandria UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mervat S Al-sedik, MD, Study chair, faculty of medicine department of obstetrics and gyneacology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04866888
- Sponsor's protocol ID
- H.R1987
- Acronym
- PAS
- Status last verified
- Feb 2025
- First submitted
- 27 Apr 2021
- Last updated
- 12 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all individual patient data (IPD) that underlies results in publication
Publications
Elshorbagy OY, Hamdy MA. Conservative surgical repair of placenta increta invading into uterine septum: case report. J Med Case Rep. 2024 Nov 18;18(1):549. doi: 10.1186/s13256-024-04814-7.
PubMed 39551821
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short and Intermediate Term Outcomes of Uterine Conservation After Cesarian Section in Cases of Placenta Accreta Spectrum
- ClinicalTrials.gov ID
- NCT04866888
- Acronym / sponsor ID
- PAS / H.R1987
- Conditions
- Placenta Accreta Spectrum
- Keywords
- PAS
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 28 Apr 2021 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 15 Mar 2026 (estimated)
- First posted
- 30 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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
| Arm | Type | Receives |
|---|---|---|
| pregnant women with placenta accreta spectrum | Experimental | Procedure: closure of the uterine wall defect, Diagnostic Test: ultrasound, Diagnostic Test: outpatient hysteroscopyBladder 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. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- • Diagnosed sonographically to have placenta accreta spectrum.
Key exclusion criteria (5 listed)
- • Patients requesting hysterectomy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| closure of the uterine wall defectAlso: double compression suturesUterine 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. | Procedure or surgery | pregnant women with placenta accreta spectrum |
| ultrasoundBefore 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 | pregnant women with placenta accreta spectrum |
| outpatient hysteroscopyAlso: office hysteroscopyOffice 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. | Diagnostic test | pregnant women with placenta accreta spectrum |
Primary outcome
date of resumed menses
Time frame: from 2 weeks to 6 months after surgery
calculate the duration from surgery until menses returns
menstrual abnormalities
Time frame: from 2 to 6 months after surgery
record type of menstrual abnormalities if present such as amenorrhea, oligomenorrhea and dysmenorrhea
abnormal uterine bleeding
Time frame: 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
Time frame: from 2 to 6 months after surgery
record the presence of pelvic pain and its duration
isthmocele
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: intraoperative until 5 months after surgery
recording method of contraception used
fibrosis
Time frame: from 3 to 6 months after surgery
grey scale ultrasound will be done to record size of intra-myometrium fibrosis
17 secondary outcomes
operation time
Time frame: intraoperative
repair time
Time frame: intraoperative
Estimated blood loss
Time frame: intraoperative
packed red blood cells transfusion
Time frame: intraoperative until 24 hours after surgery
fresh frozen plasma (FFP) transfusion
Time frame: intraoperative until 24 hours postoperative
bladder injury
Time frame: intraoperative until 2 weeks post operative
ureter injury
Time frame: intraoperative until 2 weeks post operative
bowel injury
Time frame: intraoperative until 2 weeks post operative
surgical site infection
Time frame: 24 hours until 1 month after surgery
urine output
Time frame: intraoperative
internal iliac artery ligation
Time frame: intraoperative
pre-operative hemoglobin
Time frame: preoperative
post-operative hemoglobin
Time frame: postoperative within 6 hours from surgery
hospital stay
Time frame: postoperative until 10 days after surgery
ICU admission
Time frame: immediate postoperative until 5 days after surgery
intermediate care admission
Time frame: recording the number of patients admitted to the ICU
surgical diagnosis
Time frame: intraoperative
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2025.
- Derived from this study: PubMed 39551821Elshorbagy OY, Hamdy MA. Conservative surgical repair of placenta increta invading into uterine septum: case report. J Med Case Rep. 2024 Nov 18;18(1):549. doi: 10.1186/s13256-024-04814-7.
- Individual participant dataSharing planned: Yes. all individual patient data (IPD) that underlies results in publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mervat S Al-sedik, MD study chair
faculty of medicine department of obstetrics and gyneacology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing closure of the uterine wall defect, ultrasound and outpatient hysteroscopy in people with Placenta Accreta Spectrum, run by Alexandria University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Omar Y Elshorbagy, As.lec (01111362322 ext. 002, o_kamal13@alexmed.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
date of resumed menses (time frame: from 2 weeks to 6 months after surgery). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04866888, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2025.