Placenta AccretaNCT04384510
Placenta Accreta Spectrum Protocol
An observational study of Placenta Accreta, run by Assiut University at 1 site in Egypt.
Trial summary
Aim of this project is to study diagnosis and management approaches of PAS and to assess safety and efficacy of different conservative approaches compared to planned hysterectomy. We aim at improving selection process and patient counselling for women who would like to consider alternatives to hysterectomy. Read more about this study
- Who is it for?
- Ages 18 to 48 years, women only
- Conditions the study is for
- Placenta Accreta
- What is being tested?
- Planned Cesarean hysterectomy and Conservative management
- Type of treatment
- Surgery or procedure
- How many people
- 1,500 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2020to Nov 2020
- 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 18 to 48 years
- Women only
- Adult
Study population: Women diagnosed with placenta accreta spectrum (PAS) and managed in the recuriting hospitals between 2010 and 2020, who met study selection criteria
Who may be able to join
- Pregnant women diagnosed with PAS, aged between 18 to 48 years.
- Women should be delivered by the corresponding center.
Who cannot join
- Inadequate follow-up
- Authorization to use anonymous patient data for research purposes.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Aswan Faculty of Medicine
Aswān, 81528
Amr S Abdelbadie, MBBCh, MD, love_like902@yahoo.com
About this study
Official title: Placenta Accreta Spectrum International Database (PAS-ID): Project Protocol
Aim of this project is to study diagnosis and management approaches of PAS and to assess safety and efficacy of different conservative approaches compared to planned hysterectomy. We aim at improving selection process and patient counselling for women who would like to consider alternatives to hysterectomy. To achieve these objectives, creation of an international database collected by PAS-experienced centers that represent all continents would promote conduction of large studies that provide higher level of evidence on different options of management of PAS
Read the detailed description
Placenta accreta spectrum (PAS) is a complex placentation disorder associated with high maternal morbidity; complications of PAS include hemorrhage, blood transfusion, multiple organ failure, and death
- The incidence of PAS has been increasing steadily in response to the increase in cesarean delivery rate
- Available evidence supports planned preterm cesarean hysterectomy with the placenta left in situ as the standard treatment of PAS
However, hysterectomy is traumatic to many women due to its operative sequences, impact on fertility, and disruption of self-image. Therefore, several conservative management options were proposed as an alternative to hysterectomy
- Although many of conservative approaches yielded satisfactory results, their implementation as a part of standard protocols has been limited
- There is primarily because evidence supporting most of these approaches is limited to case series, which is insufficient to support their safety. As a sequence, clinical trials are challenged by the lack of the margin of safety that would support ethical rationale of future studies. Availability of large multicenter studies is anticipated to provide robust evidence regarding optimal management of PAS and appropriate patient selection for conservative management
- Conditions
- Placenta Accreta
- Being tested
- Planned Cesarean hysterectomy, Conservative management
- Medical subject headings
- Placenta Accreta
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Planned Cesarean hysterectomyProcedure or surgery
This procedure refers to planned delivery of the fetus through Cesarean incision, leaving the placenta in situ and proceeding with hysterectomy
Conservative managementProcedure or surgery
This term describes a single or combined intervention of uterine artery ligation, internal iliac artery ligation, prophylactic balloon placement in the aorta or internal iliac artery, uterine artery embolization, compression sutures, or excision and reconstruction of uterine wall
| Study group | Role | What they receive |
|---|---|---|
| Patients with placenta accreta spectrum (PAS) | This cohort presents patients who were suspected or diagnosed either antenatal or intrapartum with placenta accreta spectrum Receives: Procedure: Planned Cesarean hysterectomy; Procedure: Conservative management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Failure of conservative management of placenta accreta spectrum (PAS)
Need for emergency or delayed hysterectomy following trial of conservative treatment
Measured: from delivery to 6 months after delivery
Secondary outcomes (4)
Maternal blood loss
Estimation of blood loss during Cesarean section in ml
Measured: From delivery and up to 24 hours postpartum
Incidence of urinary injury during intraoperative management of placenta accreta spectrum (PAS)
Incidence of urinary bladder and/or ureteric injury
Measured: From delivery and up to 6 weeks postpartum
Admission to maternal intensive care unit (ICU) after management of placenta accreta spectrum (PAS)
Admission to ICU due to maternal instability
Measured: From delivery and up to 6 weeks postpartum
Infectious morbidity after management of placenta accreta spectrum (PAS)
Incidence of sepsis and septic shock following interventions to manage PAS
Measured: From delivery and up to 6 weeks postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2020
- Study start1 Mar 2020
- Primary completion31 Aug 2020 (estimated)
- Study completionNov 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)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
- Retrospective
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sherif Abdelkarim Mohammed Shazly, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04384510
- Sponsor's protocol ID
- PAS-ID
- Status last verified
- May 2020
- First submitted
- 8 May 2020
- Last updated
- 12 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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 28599899Silver RM, Barbour KD. Placenta accreta spectrum: accreta, increta, and percreta. Obstet Gynecol Clin North Am. 2015 Jun;42(2):381-402. doi: 10.1016/j.ogc.2015.01.014.
PubMed 26002174Silver RM, Branch DW. Placenta Accreta Spectrum. N Engl J Med. 2018 Apr 19;378(16):1529-1536. doi: 10.1056/NEJMcp1709324. No abstract available.
PubMed 29669225Sentilhes 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 29405320Jauniaux E, Alfirevic Z, Bhide AG, Belfort MA, Burton GJ, Collins SL, Dornan S, Jurkovic D, Kayem G, Kingdom J, Silver R, Sentilhes L; Royal College of Obstetricians and Gynaecologists. Placenta Praevia and Placenta Accreta: Diagnosis and Management: Green-top Guideline No. 27a. BJOG. 2019 Jan;126(1):e1-e48. doi: 10.1111/1471-0528.15306. Epub 2018 Sep 27. No abstract available.
PubMed 30260097
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Placenta Accreta Spectrum International Database (PAS-ID): Project Protocol
- ClinicalTrials.gov ID
- NCT04384510
- Acronym / sponsor ID
- PAS-ID
- Conditions
- Placenta Accreta
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 31 Aug 2020 (estimated)
- Study completion
- Nov 2020 (estimated)
- First posted
- 12 May 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.
Aim of this project is to study diagnosis and management approaches of PAS and to assess safety and efficacy of different conservative approaches compared to planned hysterectomy. We aim at improving selection process and patient counselling for women who would like to consider alternatives to hysterectomy. To achieve these objectives, creation of an international database collected by PAS-experienced centers that represent all continents would promote conduction of large studies that provide higher level of evidence on different options of management of PAS
Detailed description
Placenta accreta spectrum (PAS) is a complex placentation disorder associated with high maternal morbidity; complications of PAS include hemorrhage, blood transfusion, multiple organ failure, and death
- The incidence of PAS has been increasing steadily in response to the increase in cesarean delivery rate
- Available evidence supports planned preterm cesarean hysterectomy with the placenta left in situ as the standard treatment of PAS
However, hysterectomy is traumatic to many women due to its operative sequences, impact on fertility, and disruption of self-image. Therefore, several conservative management options were proposed as an alternative to hysterectomy
- Although many of conservative approaches yielded satisfactory results, their implementation as a part of standard protocols has been limited
- There is primarily because evidence supporting most of these approaches is limited to case series, which is insufficient to support their safety. As a sequence, clinical trials are challenged by the lack of the margin of safety that would support ethical rationale of future studies. Availability of large multicenter studies is anticipated to provide robust evidence regarding optimal management of PAS and appropriate patient selection for conservative management
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with placenta accreta spectrum (PAS) | – | Procedure: Planned Cesarean hysterectomy, Procedure: Conservative managementThis cohort presents patients who were suspected or diagnosed either antenatal or intrapartum with placenta accreta spectrum |
Who may qualify
- Ages
- 18 to 48 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- Women diagnosed with placenta accreta spectrum (PAS) and managed in the recuriting hospitals between 2010 and 2020, who met study selection criteria
Key inclusion criteria (2 listed)
- Pregnant women diagnosed with PAS, aged between 18 to 48 years.
- Women should be delivered by the corresponding center.
Key exclusion criteria (2 listed)
- Inadequate follow-up
- Authorization to use anonymous patient data for research purposes.
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 |
|---|---|---|
| Planned Cesarean hysterectomyThis procedure refers to planned delivery of the fetus through Cesarean incision, leaving the placenta in situ and proceeding with hysterectomy | Procedure or surgery | Patients with placenta accreta spectrum (PAS) |
| Conservative managementThis term describes a single or combined intervention of uterine artery ligation, internal iliac artery ligation, prophylactic balloon placement in the aorta or internal iliac artery, uterine artery embolization, compression sutures, or excision and reconstruction of uterine wall | Procedure or surgery | Patients with placenta accreta spectrum (PAS) |
Primary outcome
Failure of conservative management of placenta accreta spectrum (PAS)
Time frame: from delivery to 6 months after delivery
Need for emergency or delayed hysterectomy following trial of conservative treatment
4 secondary outcomes
Maternal blood loss
Time frame: From delivery and up to 24 hours postpartum
Incidence of urinary injury during intraoperative management of placenta accreta spectrum (PAS)
Time frame: From delivery and up to 6 weeks postpartum
Admission to maternal intensive care unit (ICU) after management of placenta accreta spectrum (PAS)
Time frame: From delivery and up to 6 weeks postpartum
Infectious morbidity after management of placenta accreta spectrum (PAS)
Time frame: From delivery and up to 6 weeks postpartum
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2020.
- 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.
- Background: PubMed 26002174Silver RM, Barbour KD. Placenta accreta spectrum: accreta, increta, and percreta. Obstet Gynecol Clin North Am. 2015 Jun;42(2):381-402. doi: 10.1016/j.ogc.2015.01.014.
- Background: PubMed 29669225Silver RM, Branch DW. Placenta Accreta Spectrum. N Engl J Med. 2018 Apr 19;378(16):1529-1536. doi: 10.1056/NEJMcp1709324. No abstract available.
- Background: 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.
- Background: PubMed 30260097Jauniaux E, Alfirevic Z, Bhide AG, Belfort MA, Burton GJ, Collins SL, Dornan S, Jurkovic D, Kayem G, Kingdom J, Silver R, Sentilhes L; Royal College of Obstetricians and Gynaecologists. Placenta Praevia and Placenta Accreta: Diagnosis and Management: Green-top Guideline No. 27a. BJOG. 2019 Jan;126(1):e1-e48. doi: 10.1111/1471-0528.15306. Epub 2018 Sep 27. No abstract available.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Placenta Accreta, run by Assiut 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 2 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: status not confirmed, as of the sponsor's last update on 12 May 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sherif Shazly, MBBCh, MSc (+201276791283, shazly.sherif2020@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Failure of conservative management of placenta accreta spectrum (PAS) (time frame: from delivery to 6 months after delivery). 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 NCT04384510, which also lists 5 linked publications.
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 May 2020.