Placenta AccretaNCT05104177
Effectivness of Conservative Techniques in Management of PAS
An observational study of Placenta Accreta, run by Assiut University.
Trial summary
To evaluate the effectiveness of conservative techniques for placenta accreta spectrum to reduce maternal mortality and morbidity Read more about this study
- Who is it for?
- Ages 19 to 50 years, women only
- Conditions the study is for
- Placenta Accreta
- What is being tested?
- conservative tecchniques in management of PAS
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Nov 2021to Dec 2022
- How long will I take part?
- 10 Months
- Phase
- Observational
- 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 50 years
- Women only
- Adult
Study population: females in reproductive age
Who may be able to join
- - Gestational age starting from 28 weeks onwards.
- - Women with at least 1 previous hysterotomy (e.g. Caesarean deliveries, myomectomy)
- - Elective or emergent Caesarean deliveries
Who cannot join
- A pre-existing decision of performing intrapartum hysterectomy
Trial locations and contacts
No sites are listed yet.
About this study
To evaluate the effectiveness of conservative techniques for placenta accreta spectrum to reduce maternal mortality and morbidity
Read the detailed description
Placenta accreta spectrum (PAS) represents the spectrum of clinical conditions when part or whole of the placenta becomes abnormally adherent or invades the myometrium . Over the last 40 years, caesarean delivery rates around the world have risen from less than 10% to over 30%, and almost simultaneously a 10-fold increase in the incidence of PAS . PAS is one of the most dangerous conditions of the pregnancy as it is significantly associated with maternal morbidity and mortality .
Ultrasound imaging is the most commonly used technique to diagnose PAS disorders prenatally. There is also wide variation globally on the management of PAS disorders, with some centres opting for a radical approach, whereas others have proposed a range of conservative approaches .
The conservative approaches include one-step conservative surgery, leaving the placenta in situ, the Triple-P procedure, and transverse B-Lynch suture . Recently, Women's health hospital has adopted a new approach for conservative management of most cases of PAS, including wedge resection of the myometrium over the adherent part of the placenta, or a staged-approach following delivery of the fetus starting with meticulous dissection of the urinary bladder form the lower uterine segment, then bilateral uterine artery ligation at a level below the apparent placenta-myometrial bulge, followed by removal of the placenta, after which a catheter is inserted in the cervix and the placental pouch is closed .
- Conditions
- Placenta Accreta
- Being tested
- conservative tecchniques in management of 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.
conservative tecchniques in management of PASProcedure or surgery
Meticulous complete dissection of the urinary bladder from the lower uterine segment.
- Transverse uterine incision above the visible vascular bulge if visible in cases with anterior PAS, otherwise a transverse lower uterine segment incision is performed in the same site of previous CS scar.
- Delivery of the baby, clamping of the cord and administration IV 10 IU oxytocin.
- Bilateral uterine artery ligation at one or two levels below the lowermost part of the placenta.
- Removal of the separable part of the placenta from above downwards, until the adherent part is encountered.
- A decision is taken to either resect a wedge of the myometrium above the adherent placenta (in case the adherent area is small and anterior), or removing all the adherent placenta then inserting a rubber or plastic catheter inside the cervical canal then identifying and closing the placental pouch. Care is given to rapidly perform this step to decrease the blood loss after removing the placenta
What is being measured
The primary outcome is the main question the study is designed to answer.
number of patients who undergo hysterectomy after failure of conservative techniques
Counting patients who undergo hystrectomy after conservative techniques to evalute it's effectivness
Measured: baseline
Secondary outcomes (1)
recurrence of PAS
Nomber of cases recurrence who will have of PAS In subsequent pregnancies after conservative techniques
Measured: baseine
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2021
- Study startNov 2021 (estimated)
- Primary completionNov 2022 (estimated)
- Study completionDec 2022 (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 AccretaStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
- Target duration
- 10 Months
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Heshmat Atrees Mohammed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05104177
- Sponsor's protocol ID
- conservative techniques in PAS
- Status last verified
- Nov 2021
- First submitted
- 9 Oct 2021
- Last updated
- 9 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Jauniaux E, Collins S, Burton GJ. Placenta accreta spectrum: pathophysiology and evidence-based anatomy for prenatal ultrasound imaging. Am J Obstet Gynecol. 2018 Jan;218(1):75-87. doi: 10.1016/j.ajog.2017.05.067. Epub 2017 Jun 24.
PubMed 28599899
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectivness of Conservative Techniques in Management of PAS
- ClinicalTrials.gov ID
- NCT05104177
- Acronym / sponsor ID
- conservative techniques in PAS
- Conditions
- Placenta Accreta
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Nov 2021 (estimated)
- Primary completion
- Nov 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 2 Nov 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.
To evaluate the effectiveness of conservative techniques for placenta accreta spectrum to reduce maternal mortality and morbidity
Detailed description
Placenta accreta spectrum (PAS) represents the spectrum of clinical conditions when part or whole of the placenta becomes abnormally adherent or invades the myometrium . Over the last 40 years, caesarean delivery rates around the world have risen from less than 10% to over 30%, and almost simultaneously a 10-fold increase in the incidence of PAS . PAS is one of the most dangerous conditions of the pregnancy as it is significantly associated with maternal morbidity and mortality .
Ultrasound imaging is the most commonly used technique to diagnose PAS disorders prenatally. There is also wide variation globally on the management of PAS disorders, with some centres opting for a radical approach, whereas others have proposed a range of conservative approaches .
The conservative approaches include one-step conservative surgery, leaving the placenta in situ, the Triple-P procedure, and transverse B-Lynch suture . Recently, Women's health hospital has adopted a new approach for conservative management of most cases of PAS, including wedge resection of the myometrium over the adherent part of the placenta, or a staged-approach following delivery of the fetus starting with meticulous dissection of the urinary bladder form the lower uterine segment, then bilateral uterine artery ligation at a level below the apparent placenta-myometrial bulge, followed by removal of the placenta, after which a catheter is inserted in the cervix and the placental pouch is closed .
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Months
Who may qualify
- Ages
- 19 to 50 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- females in reproductive age
Key inclusion criteria (3 listed)
- - Gestational age starting from 28 weeks onwards.
- - Women with at least 1 previous hysterotomy (e.g. Caesarean deliveries, myomectomy)
- - Elective or emergent Caesarean deliveries
Key exclusion criteria (1 listed)
- A pre-existing decision of performing intrapartum 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 |
|---|---|---|
| conservative tecchniques in management of PASMeticulous complete dissection of the urinary bladder from the lower uterine segment. * Transverse uterine incision above the visible vascular bulge if visible in cases with anterior PAS, otherwise a transverse lower uterine segment incision is performed in the same site of previous CS scar. * Delivery of the baby, clamping of the cord and administration IV 10 IU oxytocin. * Bilateral uterine artery ligation at one or two levels below the lowermost part of the placenta. * Removal of the separable part of the placenta from above downwards, until the adherent part is encountered. * A decision is taken to either resect a wedge of the myometrium above the adherent placenta (in case the adherent area is small and anterior), or removing all the adherent placenta then inserting a rubber or plastic catheter inside the cervical canal then identifying and closing the placental pouch. Care is given to rapidly perform this step to decrease the blood loss after removing the placenta | Procedure or surgery | – |
Primary outcome
number of patients who undergo hysterectomy after failure of conservative techniques
Time frame: baseline
Counting patients who undergo hystrectomy after conservative techniques to evalute it's effectivness
1 secondary outcome
recurrence of PAS
Time frame: baseine
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2021.
- Background: PubMed 28599899Jauniaux E, Collins S, Burton GJ. Placenta accreta spectrum: pathophysiology and evidence-based anatomy for prenatal ultrasound imaging. Am J Obstet Gynecol. 2018 Jan;218(1):75-87. doi: 10.1016/j.ajog.2017.05.067. Epub 2017 Jun 24.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Placenta Accreta, run by Assiut University.
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 1 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: status not confirmed, as of the sponsor's last update on 9 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact mohammed heshmat (01030752354, heshmatm905@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of patients who undergo hysterectomy after failure of conservative techniques (time frame: baseline). 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 NCT05104177, 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 9 Nov 2021; AzTrials last refreshed its copy on 7 Nov 2026.