- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04384510
Placenta Accreta Spectrum Protocol
Placenta Accreta Spectrum International Database (PAS-ID): Project Protocol
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Sherif Shazly, MBBCh, MSc
- Phone Number: +201276791283
- Email: shazly.sherif2020@gmail.com
Study Locations
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-
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Aswan, Egypt, 81528
- Recruiting
- Aswan Faculty of Medicine
-
Contact:
- Amr S Abdelbadie, MBBCh, MD
- Email: love_like902@yahoo.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Pregnant women diagnosed with PAS, aged between 18 to 48 years.
- Women should be delivered by the corresponding center.
Exclusion Criteria:
- Inadequate follow-up
- Authorization to use anonymous patient data for research purposes.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Patients with placenta accreta spectrum (PAS)
This cohort presents patients who were suspected or diagnosed either antenatal or intrapartum with placenta accreta spectrum
|
This procedure refers to planned delivery of the fetus through Cesarean incision, leaving the placenta in situ and proceeding with hysterectomy
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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from delivery to 6 months after delivery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maternal blood loss
Time Frame: From delivery and up to 24 hours postpartum
|
Estimation of blood loss during Cesarean section in ml
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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
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Incidence of urinary bladder and/or ureteric injury
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From delivery and up to 6 weeks postpartum
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Admission to maternal intensive care unit (ICU) after management of placenta accreta spectrum (PAS)
Time Frame: From delivery and up to 6 weeks postpartum
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Admission to ICU due to maternal instability
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From delivery and up to 6 weeks postpartum
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Infectious morbidity after management of placenta accreta spectrum (PAS)
Time Frame: From delivery and up to 6 weeks postpartum
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Incidence of sepsis and septic shock following interventions to manage PAS
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From delivery and up to 6 weeks postpartum
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Silver RM, Branch DW. Placenta Accreta Spectrum. N Engl J Med. 2018 Apr 19;378(16):1529-1536. doi: 10.1056/NEJMcp1709324. No abstract available.
- 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.
- 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.
- Jauniaux 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.
- Silver 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PAS-ID
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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