Placenta Accreta Spectrum Topographic Classification

Placenta Accreta Clinical Trial

Official title:

Evaluation of Clinical Outcomes and Acceptability of an Anatomical Classification for Placenta Accreta Spectrum, a Multicentric Prospective Cohort Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05922397
• Other study ID #: FVL-2125
• Status: Recruiting
• Start date: May 21, 2023
• Est. completion date: June 1, 2025

Study information

• Verified date: July 2023
• Source: Fundacion Clinica Valle del Lili
• Contact: Albaro J Nieto-Calvache, MD
• Phone: 6023319090
• Email: albaro.nieto[@]fvl.org.co
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The present study is a prospective multicenter study consisting of a cohort of patients with prenatal or intraoperative diagnosis of PAS, evaluating the clinical outcomes of the group of patients found in each category of the topographic classification. In addition, an approach to evaluate the acceptability of this classification among the obstetrician-gynecologists of the participating medical centers will be included.

Description:

The aim of this study is to describe the demographic and clinical characteristics of patients with a diagnosis of placenta accreta spectrum, and to determine the correlation between the topographic classification and the clinical outcomes found in the study. Finally, to evaluated whether the proposed classification is accepted by the obstetrician-gynecologists of the participating centers that manage placenta accreta spectrum patients.

It is an observational, multicentric study of a prospective cohort, in which data will be obtained from the medical records and other documents in each participating center, which are considered to be of routine use in day-to-day clinical practice. The study of the outcomes proposed in this protocol will be limited to those recorded in the clinical records and will be taken into account until the participant is discharged from the hospital, during which a surgical intervention was performed due to the suspicion or diagnosis of PAS.

It is projected that the period of patient enrollment will last 2 years, counting on from the first participant included. The study population is pregnant patients with a diagnosis of placenta accreta spectrum who visits any of the participating medical centers, and also obstetrician-gynecologists working in participating medical centers.

The centers invited to participate are hospitals or clinics that already have knowledge in how to apply the surgical staging of PAS, and the topographic classification and have experience using it.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 326
• Est. completion date: June 1, 2025
• Est. primary completion date: June 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Pregnant woman over 18 years old.

• Prenatal diagnosis by ultrasound or MRI of PAS, regardless of the suspected degree of severity of the disease.

• Case requiring surgical management, either as scheduled or emergent procedure.

• Application of the topographic classification of placenta accreta spectrum during laparotomy.

Exclusion Criteria:

• None.

Related Conditions & MeSH terms

• Placenta Accreta

Locations

Country	Name	City	State
Colombia	Fundación Valle del Lili	Cali

Sponsors (1)

Lead Sponsor	Collaborator
Fundacion Clinica Valle del Lili

Country where clinical trial is conducted

Colombia, 

References & Publications (28)

Allen L, Jauniaux E, Hobson S, Papillon-Smith J, Belfort MA; FIGO Placenta Accreta Diagnosis and Management Expert Consensus Panel. FIGO consensus guidelines on placenta accreta spectrum disorders: Nonconservative surgical management. Int J Gynaecol Obstet. 2018 Mar;140(3):281-290. doi: 10.1002/ijgo.12409. No abstract available. — View Citation

Aryananda RA, Aditiawarman A, Gumilar KE, Wardhana MP, Akbar MIA, Cininta N, Ernawati E, Wicaksono B, Joewono HT, Dachlan EG, Bachtiar CA, Kurniawati D, Virdayanti DP, Ariani G, Dekker GA, Sulistyono A. Uterine conservative-resective surgery for selected placenta accreta spectrum cases: Surgical-vascular control methods. Acta Obstet Gynecol Scand. 2022 Jun;101(6):639-648. doi: 10.1111/aogs.14348. Epub 2022 Mar 17. — View Citation

Brown AD, Hart JM, Modest AM, Hess PE, Abbas AM, Nieto-Calvache AJ, Bhide A, Lim B, Dunjin C, Palacios-Jaraquemada J, Sentilhes L, Soma-Pillay P, Aryananda RA, Hantoushzadeh S, Wang S, Shamshirsaz AA, Shainker SA. Geographic variation in management of patients with placenta accreta spectrum: An international survey of experts (GPASS). Int J Gynaecol Obstet. 2022 Jul;158(1):129-136. doi: 10.1002/ijgo.13960. Epub 2021 Oct 28. — View Citation

Chandraharan E. Need for an urgent paradigms shift in thinking to avoid serious maternal morbidity and mortality associated with PAS. Best Pract Res Clin Obstet Gynaecol. 2021 Apr;72:1-3. doi: 10.1016/j.bpobgyn.2021.04.001. No abstract available. — View Citation

Collins SL, Stevenson GN, Al-Khan A, Illsley NP, Impey L, Pappas L, Zamudio S. Three-Dimensional Power Doppler Ultrasonography for Diagnosing Abnormally Invasive Placenta and Quantifying the Risk. Obstet Gynecol. 2015 Sep;126(3):645-653. doi: 10.1097/AOG.0000000000000962. — View Citation

Einerson BD, Watt MH, Sartori B, Silver R, Rothwell E. Lived experiences of patients with placenta accreta spectrum in Utah: a qualitative study of semi-structured interviews. BMJ Open. 2021 Nov 3;11(11):e052766. doi: 10.1136/bmjopen-2021-052766. — View Citation

Garmi G, Salim R. Epidemiology, etiology, diagnosis, and management of placenta accreta. Obstet Gynecol Int. 2012;2012:873929. doi: 10.1155/2012/873929. Epub 2012 May 7. — View Citation

Hussein AM, Elbarmelgy RA, Elbarmelgy RM, Thabet MM, Jauniaux E. Prospective evaluation of impact of post-Cesarean section uterine scarring in perinatal diagnosis of placenta accreta spectrum disorder. Ultrasound Obstet Gynecol. 2022 Apr;59(4):474-482. doi: 10.1002/uog.23732. Epub 2022 Mar 8. — View Citation

Hussein AM, Kamel A, Raslan A, Dakhly DMR, Abdelhafeez A, Nabil M, Momtaz M. Modified cesarean hysterectomy technique for management of cases of placenta increta and percreta at a tertiary referral hospital in Egypt. Arch Gynecol Obstet. 2019 Mar;299(3):695-702. doi: 10.1007/s00404-018-5027-7. Epub 2019 Jan 4. — View Citation

Jauniaux E, Ayres-de-Campos D, Langhoff-Roos J, Fox KA, Collins S; FIGO Placenta Accreta Diagnosis and Management Expert Consensus Panel. FIGO classification for the clinical diagnosis of placenta accreta spectrum disorders. Int J Gynaecol Obstet. 2019 Jul;146(1):20-24. doi: 10.1002/ijgo.12761. — View Citation

Jauniaux E, Jurkovic D, Hussein AM, Burton GJ. New insights into the etiopathology of placenta accreta spectrum. Am J Obstet Gynecol. 2022 Sep;227(3):384-391. doi: 10.1016/j.ajog.2022.02.038. Epub 2022 Mar 3. — View Citation

Kingdom JC, Hobson SR, Murji A, Allen L, Windrim RC, Lockhart E, Collins SL, Soleymani Majd H, Alazzam M, Naaisa F, Shamshirsaz AA, Belfort MA, Fox KA. Minimizing surgical blood loss at cesarean hysterectomy for placenta previa with evidence of placenta increta or placenta percreta: the state of play in 2020. Am J Obstet Gynecol. 2020 Sep;223(3):322-329. doi: 10.1016/j.ajog.2020.01.044. Epub 2020 Jan 30. — View Citation

Melber DJ, Berman ZT, Jacobs MB, Picel AC, Conturie CL, Zhang-Rutledge K, Binder PS, Eskander RN, Roberts AC, McHale MT, Ramos GA, Ballas J, Kelly TF. Placenta Accreta Spectrum Treatment With Intraoperative Multivessel Embolization: the PASTIME protocol. Am J Obstet Gynecol. 2021 Oct;225(4):442.e1-442.e10. doi: 10.1016/j.ajog.2021.07.001. Epub 2021 Jul 7. — View Citation

Nieto AJ, Echavarria MP, Carvajal JA, Messa A, Burgos JM, Ordonez C, Benavidez JP, Mejia M, Lopez L, Fernandez PA, Escobar MF. Placenta accreta: importance of a multidisciplinary approach in the Colombian hospital setting. J Matern Fetal Neonatal Med. 2020 Apr;33(8):1321-1329. doi: 10.1080/14767058.2018.1517328. Epub 2018 Sep 25. — View Citation

Nieto-Calvache AJ, Hidalgo-Cardona A, Lopez-Giron MC, Rodriguez F, Ordonez C, Garcia AF, Mejia M, Pabon-Parra MG, Burgos-Luna JM. Arterial thrombosis after REBOA use in placenta accreta spectrum: a case series. J Matern Fetal Neonatal Med. 2022 Nov;35(21):4031-4034. doi: 10.1080/14767058.2020.1846178. Epub 2020 Nov 18. — View Citation

Nieto-Calvache AJ, Lopez-Giron MC, Nieto-Calvache A, Messa-Bryon A, Benavides-Calvache JP, Burgos-Luna JM. A nationwide survey of centers with multidisciplinary teams for placenta accreta patient care in Colombia, observational study. J Matern Fetal Neonatal Med. 2022 Jun;35(12):2331-2337. doi: 10.1080/14767058.2020.1786052. Epub 2020 Jul 6. — View Citation

Nieto-Calvache AJ, Palacios-Jaraquemada JM, Aguilera LR, Arriaga W, Colonia A, Aryananda RA, Nieto-Calvache AS, Maya J, Vergara-Galliadi LM, Messa Bryon A. Telemedicine facilitates surgical training in placenta accreta spectrum. Int J Gynaecol Obstet. 2022 Jul;158(1):137-144. doi: 10.1002/ijgo.14000. Epub 2021 Nov 20. — View Citation

Nieto-Calvache AJ, Palacios-Jaraquemada JM, Aryananda R, Basanta N, Aguilera R, Benavides JP, Lopez J, Campos C, Valencia L, Arboleda K, Cabrera V, Cabrera J, Tavera-Martinez GM, Sinisterra S, Maya J, Pena T, Burgos-Luna JM, Messa A. How to perform the one-step conservative surgery for placenta accreta spectrum move by move. Am J Obstet Gynecol MFM. 2023 Feb;5(2):100802. doi: 10.1016/j.ajogmf.2022.100802. Epub 2022 Nov 11. — View Citation

Nieto-Calvache AJ, Palacios-Jaraquemada JM, Aryananda RA, Rodriguez F, Ordonez CA, Messa Bryon A, Calvache JPB, Lopez J, Campos CI, Mejia M, Rengifo M, Galliadi LMV, Maya J, Zambrano MA, Aguayo IP, Carabali IG, Burgos JM. How to identify patients who require aortic vascular control in placenta accreta spectrum disorders? Am J Obstet Gynecol MFM. 2022 Jan;4(1):100498. doi: 10.1016/j.ajogmf.2021.100498. Epub 2021 Oct 2. — View Citation

Nieto-Calvache AJ, Palacios-Jaraquemada JM, Hidalgo A, Vergara-Galliadi LM, Cortes Charry R, Aguilera Daga LR, Verastegui Goyzueta R, Osanan G, Fernandez J, Corrales F, Mereci W, Yuen-Chon V, Guevara E, Zuniga LA, Giron, Turcios FE, Munoz H, Perez AM, Meade P, Basanta N, Pineda JP. Management practices for placenta accreta spectrum patients: a Latin American hospital survey. J Matern Fetal Neonatal Med. 2022 Dec;35(25):6104-6111. doi: 10.1080/14767058.2021.1906858. Epub 2021 Apr 11. — View Citation

Palacios Jaraquemada JM, Garcia Monaco R, Barbosa NE, Ferle L, Iriarte H, Conesa HA. Lower uterine blood supply: extrauterine anastomotic system and its application in surgical devascularization techniques. Acta Obstet Gynecol Scand. 2007;86(2):228-34. doi: 10.1080/00016340601089875. — View Citation

Palacios-Jaraquemada JM, D'Antonio F. Possible limitation to use the International Federation of Gynecology and Obstetrics classification of placenta accreta spectrum. Am J Obstet Gynecol. 2020 Dec;223(6):944. doi: 10.1016/j.ajog.2020.06.033. Epub 2020 Jun 19. No abstract available. — View Citation

Palacios-Jaraquemada JM, Fiorillo A, Hamer J, Martinez M, Bruno C. Placenta accreta spectrum: a hysterectomy can be prevented in almost 80% of cases using a resective-reconstructive technique. J Matern Fetal Neonatal Med. 2022 Jan;35(2):275-282. doi: 10.1080/14767058.2020.1716715. Epub 2020 Jan 26. — View Citation

Sargent W, Collins SL. Are women antenatally diagnosed with abnormally invasive placenta receiving optimal management in England? An observational study of planned place of delivery. Acta Obstet Gynecol Scand. 2019 Mar;98(3):337-341. doi: 10.1111/aogs.13487. Epub 2018 Nov 15. — View 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. — View Citation

Sentilhes L, Seco A, Azria E, Beucher G, Bonnet MP, Branger B, Carbillon L, Chiesa C, Crenn-Hebert C, Dreyfus M, Dupont C, Fresson J, Huissoud C, Langer B, Morel O, Patrier S, Perrotin F, Raynal P, Rozenberg P, Rudigoz RC, Vendittelli F, Winer N, Deneux-Tharaux C, Kayem G; PACCRETA Study Group. Conservative management or cesarean hysterectomy for placenta accreta spectrum: the PACCRETA prospective study. Am J Obstet Gynecol. 2022 Jun;226(6):839.e1-839.e24. doi: 10.1016/j.ajog.2021.12.013. Epub 2021 Dec 14. — View Citation

Shamshirsaz AA, Fox KA, Erfani H, Clark SL, Salmanian B, Baker BW, Coburn M, Shamshirsaz AA, Bateni ZH, Espinoza J, Nassr AA, Popek EJ, Hui SK, Teruya J, Tung CS, Jones JA, Rac M, Dildy GA, Belfort MA. Multidisciplinary team learning in the management of the morbidly adherent placenta: outcome improvements over time. Am J Obstet Gynecol. 2017 Jun;216(6):612.e1-612.e5. doi: 10.1016/j.ajog.2017.02.016. Epub 2017 Feb 16. — View Citation

Whittington JR, Pagan ME, Nevil BD, Kalkwarf KJ, Sharawi NE, Hughes DS, Sandlin AT. Risk of vascular complications in prophylactic compared to emergent resuscitative endovascular balloon occlusion of the aorta (REBOA) in the management of placenta accreta spectrum. J Matern Fetal Neonatal Med. 2022 Aug;35(16):3049-3052. doi: 10.1080/14767058.2020.1802717. Epub 2020 Aug 11. — View Citation

* Note: There are 28 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Days of postoperative hospitalization	Number of days the patient was hospitalized from the day of surgery to the day of discharge	From the day the surgery is performed until the day of discharge or the date of death from any cause, whichever occurs first, evaluated up to 42 days.
Primary	Volume of intraoperative blood loss	Surgical bleeding calculated in milliliters	During surgery
Primary	Bladder injury	Number of patients who had Bladder injuries	Up to 42 days postpartum
Primary	Surgical reintervention	Number of patients who need surgical reoperation after index surgery	Up to 42 days postpartum
Primary	Complications associated with vascular interventions	The patient presented thrombosis or other complication during post-surgery associated with vascular interventions.	Up to 42 days postpartum
Primary	Maternal death	Does the patient die during this study	24 months