Clinical trial NCT04384510: Placenta Accreta Spectrum Protocol
Official title: Placenta Accreta Spectrum International Database (PAS-ID): Project Protocol
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Placenta Accreta
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2020-05-12
Enrollment: 1500
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 48
Standard ages: ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women diagnosed with placenta accreta spectrum (PAS) and managed in the recuriting hospitals between 2010 and 2020, who met study selection criteria

Brief 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. 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

Eligibility criteria: 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.

Primary outcomes:
measure: Failure of conservative management of placenta accreta spectrum (PAS)
timeFrame: from delivery to 6 months after delivery
Secondary outcomes:
measure: Maternal blood loss
timeFrame: From delivery and up to 24 hours postpartum
measure: Incidence of urinary injury during intraoperative management of placenta accreta spectrum (PAS)
timeFrame: From delivery and up to 6 weeks postpartum
measure: Admission to maternal intensive care unit (ICU) after management of placenta accreta spectrum (PAS)
timeFrame: From delivery and up to 6 weeks postpartum
measure: Infectious morbidity after management of placenta accreta spectrum (PAS)
timeFrame: From delivery and up to 6 weeks postpartum
Other outcomes:
Locations:
city: Aswan
country: Egypt
facility: Aswan Faculty of Medicine
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.