Placenta Accreta SpectrumpercretaNCT04427592
New Conservative Technique for Placenta Accreta Spectrum
A study testing ultrasound and closure of uterine wall defect in people with Placenta Accreta Spectrum, run by Alexandria University at 1 site in Egypt.
Trial summary
participants diagnosed as placenta accreta spectrum were subjected to cesarean delivery. Investigators manually detected a plan of cleavage through which the placenta was separated followed by closure of defective placental bed. Data were collected about the outcome. Read more about this study
- Who is it for?
- Ages 19 to 40 years, women only
- Conditions the study is for
- Placenta Accreta Spectrum
- What is being tested?
- ultrasound and closure of uterine wall defect
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 159 participants
- Where
- 1 siteEgypt
- Study dates
- 28 Jul 2020to 20 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 19 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- pregnant women diagnosed as placenta accreta spectrum with previous Cesarean section, with or without other uterine surgeries and less than 40 years of age.
Who cannot join
- pregnant women having medical conditions such as cardiac diseases, coagulopathy and hematological disorders.
- pregnant women had 5 or more previous Cesarean sections or their age more than 40 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Placenta Accreta; A Vision for Conservative Surgery
participants diagnosed as placenta accreta spectrum were subjected to cesarean delivery.
Investigators manually detected a plan of cleavage through which the placenta was separated followed by closure of defective placental bed.
Data were collected about the outcome.
Read the detailed description
Demographic data, detailed history taking, routine blood tests were done. Trans-abdominal and trans-vaginal ultrasound to diagnose placenta accreta spectrum ( PAS). Detecting new signs to help sure diagnosis of PAS.
Cesarean section will be performed through extended transverse supra-pubic incision bladder dissection from anterior uterine wall using electro-coagulation instruments and double ligation of large caliber bridging vessels.
Uterine incision above the placental bulge by at least 5 mm then complete separation of the placenta starting from least resistance plans to high resistant one leaving a clear defect which will be closed by running sutures from inside the uterus and controlling placental bed hemorrhage then closing the uterine incision with compressing the bed from outwards ( double compression sutures ) internal Iliac artery ligation may be done as a complementary measure to control the bleeding from abnormal pelvic vasculature, insertion of intraperitoneal drain and closure of abdominal wall in layers.
- Conditions
- Placenta Accreta Spectrum
- Being tested
- ultrasound, closure of uterine wall defect
- Medical subject headings
- Placenta Accreta
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasoundDiagnostic test
trans-vaginal and trans-abdominal ultrasound using different modalities such as grey-scale, Doppler, multi-planer mode
closure of uterine wall defectProcedure or surgery
Also called Double compression suture
uterine incision above placental bulge by at least 5 mm then complete separation of the placenta starting from areas of least resistance to areas of high resistance leaving a clear defect which will be closed by non locked running sutures from inside the uterus starting from one edge, hitch the bed to the other edge of the defect and controlling placental bed hemorrhage then closing the uterine incision via running sutures in 2 layers with compressing the bed from outwards in the first layer. hemostasis of the abnormal pelvic vasculature if excessive bleeding internal iliac artery may be ligated then insertion of intra-peritoneal drain followed by closing the abdomen.
| Study group | Role | What they receive |
|---|---|---|
| pregnant women with placenta accreta spectrum | Experimental | The participants were subjected to ultrasound to diagnose placenta accreta spectrum followed by new conservative surgical technique. Receives: Diagnostic Test: ultrasound; Procedure: closure of uterine wall defect |
What is being measured
The primary outcome is the main question the study is designed to answer.
surgical outcome
number of participants whom their uterus were preserved without major hemorrhage
Measured: from the time of the surgery until 48 hours after.
intra-operative blood loss
the amount of blood loss during operation was estimated for each participant.
Measured: intraoperative
surgical complications
number of participants had bladder, ureter injury or hysterectomy,
Measured: intraoperative
internal iliac artery ligation
number of participants had with either unilateral or bilateral internal iliac artery ligation
Measured: intra-operative
high dependency unit admission
number of participants needed high dependency unit admission
Measured: from 0 to 48 hours postoperative
wound complications
number of patients suffered wound infection
Measured: up to 2 weeks postoperative
change in the hemoglobin level
participant's hemoglobin was measured
Measured: from 48 hours pre operative to 48 hours post operative
blood transfusion
number of units of blood and it's products transfused to participants
Measured: from 48 hours preoperative to 48 hours postoperative.
hematuria
number of participants suffered hematuria
Measured: post-operative up to 24 hours
manual cervical assesment
participants were subjected to vaginal examination to asses the cervix lenght
Measured: before skin incision
placental separation
number of participants whom their placenta was separated manually
Measured: intra-operative
surgical grading of the placenta
number of participants who had accreta, increta, percreta or mixed type
Measured: intra-operative
ultrasound grading of the placenta
number of participants who were diagnosed by ultrasound as accreta, increta or percreta
Measured: pre-operative
manual assessment of vaginal fornices
participants were subjected to vaginal examination to assess fornices
Measured: before skin incision
repair time
the time recorded from the end of the placental separation to the closure of the first layer of the uterus
Measured: intra-operative
total operation time
the time taken from the start of the skin incision to the skin closure
Measured: intra-operative
Secondary outcomes (3)
placental bed
number of participants that investigators detected a well delineated placental bed like a pouch
Measured: intra-operative
pouch site
the site of the pouch in relation to the cervix
Measured: intra-operative
defect site
the location of the myometrium defects
Measured: intra-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2020
- Study start28 Jul 2020
- Primary completion20 Apr 2023
- Study completion20 May 2023
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.
- 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
- Investigators conducting prospective study for management of placenta accreta spectrum including diagnosis and uterine sparing surgery.
- Masking
- None (open label)
- Enrolment
- 159 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud A Hamdy, Alexandria University
- Investigators
- Mahmoud AH Hamdy, A. lecturer, Principal investigator, faculty of medicine department of obstetrics and gyneacology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04427592
- Sponsor's protocol ID
- H.R501
- Acronym
- percreta
- Status last verified
- Dec 2023
- First submitted
- 31 May 2020
- Last updated
- 6 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all IPD that underlies results in publication
Publications
Sentilhes L, Kayem G, Chandraharan E, Palacios-Jaraquemada J, Jauniaux E; FIGO Placenta Accreta Diagnosis and Management Expert Consensus Panel. FIGO consensus guidelines on placenta accreta spectrum disorders: Conservative management. Int J Gynaecol Obstet. 2018 Mar;140(3):291-298. doi: 10.1002/ijgo.12410. No abstract available.
PubMed 29405320
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Placenta Accreta; A Vision for Conservative Surgery
- ClinicalTrials.gov ID
- NCT04427592
- Acronym / sponsor ID
- percreta / H.R501
- Conditions
- Placenta Accreta Spectrum
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 159 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 28 Jul 2020 (actual)
- Primary completion
- 20 Apr 2023 (actual)
- Study completion
- 20 May 2023 (actual)
- First posted
- 11 Jun 2020 (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.
participants diagnosed as placenta accreta spectrum were subjected to cesarean delivery.
Investigators manually detected a plan of cleavage through which the placenta was separated followed by closure of defective placental bed.
Data were collected about the outcome.
Detailed description
Demographic data, detailed history taking, routine blood tests were done. Trans-abdominal and trans-vaginal ultrasound to diagnose placenta accreta spectrum ( PAS). Detecting new signs to help sure diagnosis of PAS.
Cesarean section will be performed through extended transverse supra-pubic incision bladder dissection from anterior uterine wall using electro-coagulation instruments and double ligation of large caliber bridging vessels.
Uterine incision above the placental bulge by at least 5 mm then complete separation of the placenta starting from least resistance plans to high resistant one leaving a clear defect which will be closed by running sutures from inside the uterus and controlling placental bed hemorrhage then closing the uterine incision with compressing the bed from outwards ( double compression sutures ) internal Iliac artery ligation may be done as a complementary measure to control the bleeding from abnormal pelvic vasculature, insertion of intraperitoneal drain and closure of abdominal wall in layers.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Investigators conducting prospective study for management of placenta accreta spectrum including diagnosis and uterine sparing surgery.
| Arm | Type | Receives |
|---|---|---|
| pregnant women with placenta accreta spectrum | Experimental | Diagnostic Test: ultrasound, Procedure: closure of uterine wall defectThe participants were subjected to ultrasound to diagnose placenta accreta spectrum followed by new conservative surgical technique. |
Who may qualify
- Ages
- 19 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- pregnant women diagnosed as placenta accreta spectrum with previous Cesarean section, with or without other uterine surgeries and less than 40 years of age.
Key exclusion criteria (2 listed)
- pregnant women having medical conditions such as cardiac diseases, coagulopathy and hematological disorders.
- pregnant women had 5 or more previous Cesarean sections or their age more than 40 years
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 |
|---|---|---|
| ultrasoundtrans-vaginal and trans-abdominal ultrasound using different modalities such as grey-scale, Doppler, multi-planer mode | Diagnostic test | pregnant women with placenta accreta spectrum |
| closure of uterine wall defectAlso: Double compression sutureuterine incision above placental bulge by at least 5 mm then complete separation of the placenta starting from areas of least resistance to areas of high resistance leaving a clear defect which will be closed by non locked running sutures from inside the uterus starting from one edge, hitch the bed to the other edge of the defect and controlling placental bed hemorrhage then closing the uterine incision via running sutures in 2 layers with compressing the bed from outwards in the first layer. hemostasis of the abnormal pelvic vasculature if excessive bleeding internal iliac artery may be ligated then insertion of intra-peritoneal drain followed by closing the abdomen. | Procedure or surgery | pregnant women with placenta accreta spectrum |
Primary outcome
surgical outcome
Time frame: from the time of the surgery until 48 hours after.
number of participants whom their uterus were preserved without major hemorrhage
intra-operative blood loss
Time frame: intraoperative
the amount of blood loss during operation was estimated for each participant.
surgical complications
Time frame: intraoperative
number of participants had bladder, ureter injury or hysterectomy,
internal iliac artery ligation
Time frame: intra-operative
number of participants had with either unilateral or bilateral internal iliac artery ligation
high dependency unit admission
Time frame: from 0 to 48 hours postoperative
number of participants needed high dependency unit admission
wound complications
Time frame: up to 2 weeks postoperative
number of patients suffered wound infection
change in the hemoglobin level
Time frame: from 48 hours pre operative to 48 hours post operative
participant's hemoglobin was measured
blood transfusion
Time frame: from 48 hours preoperative to 48 hours postoperative.
number of units of blood and it's products transfused to participants
hematuria
Time frame: post-operative up to 24 hours
number of participants suffered hematuria
manual cervical assesment
Time frame: before skin incision
participants were subjected to vaginal examination to asses the cervix lenght
placental separation
Time frame: intra-operative
number of participants whom their placenta was separated manually
surgical grading of the placenta
Time frame: intra-operative
number of participants who had accreta, increta, percreta or mixed type
ultrasound grading of the placenta
Time frame: pre-operative
number of participants who were diagnosed by ultrasound as accreta, increta or percreta
manual assessment of vaginal fornices
Time frame: before skin incision
participants were subjected to vaginal examination to assess fornices
repair time
Time frame: intra-operative
the time recorded from the end of the placental separation to the closure of the first layer of the uterus
total operation time
Time frame: intra-operative
the time taken from the start of the skin incision to the skin closure
3 secondary outcomes
placental bed
Time frame: intra-operative
pouch site
Time frame: intra-operative
defect site
Time frame: intra-operative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2023.
- Results publication: PubMed 29405320Sentilhes L, Kayem G, Chandraharan E, Palacios-Jaraquemada J, Jauniaux E; FIGO Placenta Accreta Diagnosis and Management Expert Consensus Panel. FIGO consensus guidelines on placenta accreta spectrum disorders: Conservative management. Int J Gynaecol Obstet. 2018 Mar;140(3):291-298. doi: 10.1002/ijgo.12410. No abstract available.
- Individual participant dataSharing planned: Yes. all 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. This study is not recruiting at the moment.
Mahmoud AH Hamdy, A. lecturer principal investigator
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 ultrasound and closure of uterine wall defect 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 1 inclusion and 2 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: finished, as of the sponsor's last update on 6 Dec 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
surgical outcome (time frame: from the time of the surgery until 48 hours after.). The study lists 16 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 NCT04427592, 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 6 Dec 2023.