Histerectomy Vs Partial Myometrial Resection for Placenta Accreta Spectrum
NCT ID: NCT05013749
Last Updated: 2024-11-25
Study Results
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View full resultsBasic Information
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COMPLETED
NA
60 participants
INTERVENTIONAL
2021-08-20
2023-04-17
Brief Summary
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The present study is a feasibility study of a multicenter, randomized controlled clinical trial to be carried out in 3 health institutions. Patients who meet the inclusion criteria, after signing the informed consent, will be taken to the surgical procedure and before the start of the procedure they will be randomized to one of the two interventions, hysterectomy or partial myometrial resection, intra-surgical clinical outcomes will be explored and a follow-up will be carried out during the immediate post-surgical period (72 hours), in 7 to 12 days and at 42 days postpartum.
A sample size of 60 patients is estimated among the 3 health institutions, with an approximate duration of the study of 24 months.
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Detailed Description
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We performed a prospectively registered multicenter randomized controlled trial comparing hysterectomy with 1-step conservative surgery. The aim was to collect feasibility and clinical outcomes of the 2 techniques in women assigned to hysterectomy or 1step conservative surgery. In addition to assessing participants' willingness to be randomized, we also collected data on intraoperative blood loss, transfusion requirement, serious adverse event, and other clinical outcomes.
Sixty women with strong antenatal suspicion of placenta accreta spectrum were assigned randomly to either hysterectomy (n=31) or 1-step conservative surgery (n=29).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
If the diagnosis of PAS is confirmed by observing the clinical criteria endorsed by the International Federation of Gynecology and Obstetrics (FIGO), the patient's participation in the study is confirmed and the surgical procedure defined by randomization is continued, that is, one of the two arms of the study: Primary hysterectomy or Partial myometrial resection.
TREATMENT
NONE
Study Groups
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Hysterectomy
Hysterectomy: An incision will be made above the level of the placenta, delivering the newborn. Uterotonics will be administered, and spontaneous delivery of the placenta will be awaited using gentle traction. The absence of spontaneous separation of the placenta will confirm the diagnosis of PAS, the patient will undergo to hysterectomy. The complete removal of the uterus will be attempted, including the cervix, the duration of the intervention and intraoperative blood loss will be recorded, as well as the damage to organs neighboring the uterus. In this arm of the study, to hysterectomy will be performed in 100% of patients
Hysterectomy
Hysterectomy: An incision will be made above the level of the placenta, delivering the newborn. Uterotonics will be administered, and spontaneous delivery of the placenta will be awaited using gentle traction. The absence of spontaneous separation of the placenta will confirm the diagnosis of PAS, the patient will undergo to hysterectomy. The complete removal of the uterus will be attempted, including the cervix, the duration of the intervention and intraoperative blood loss will be recorded, as well as the damage to organs neighboring the uterus. In this arm of the study, to hysterectomy will be performed in 100% of patients
Partial myometrial resection
Partial myometrial resection: The technique described by Palacios-Jaraquemada et al5. will be followed. Briefly, the uterus will be dissected to free it from the posterior wall of the bladder to the cervix. The vesicouterine vessels will be ligated and the parametrial space will be visualized. The hysterotomy will be performed in the upper segment, immediately above the area of invasion of the myometrium. The entire invaded myometrium and the entire placenta will be removed. The uterus will repair itself in one or two layers. Intrauterine balloon tamponade will be used if indicated.
Partial Myometrial Resection
Partial myometrial resection: The technique described by Palacios-Jaraquemada et al5. will be followed. Briefly, the uterus will be dissected to free it from the posterior wall of the bladder to the cervix. The vesico-uterine vessels will be ligated and the parametrial space will be visualized. The hysterotomy will be performed in the upper segment, immediately above the area of invasion of the myometrium. The entire invaded myometrium and the entire placenta will be removed. The uterus will repair itself in one or two layers. Intrauterine balloon tamponade will be used if indicated.
Interventions
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Hysterectomy
Hysterectomy: An incision will be made above the level of the placenta, delivering the newborn. Uterotonics will be administered, and spontaneous delivery of the placenta will be awaited using gentle traction. The absence of spontaneous separation of the placenta will confirm the diagnosis of PAS, the patient will undergo to hysterectomy. The complete removal of the uterus will be attempted, including the cervix, the duration of the intervention and intraoperative blood loss will be recorded, as well as the damage to organs neighboring the uterus. In this arm of the study, to hysterectomy will be performed in 100% of patients
Partial Myometrial Resection
Partial myometrial resection: The technique described by Palacios-Jaraquemada et al5. will be followed. Briefly, the uterus will be dissected to free it from the posterior wall of the bladder to the cervix. The vesico-uterine vessels will be ligated and the parametrial space will be visualized. The hysterotomy will be performed in the upper segment, immediately above the area of invasion of the myometrium. The entire invaded myometrium and the entire placenta will be removed. The uterus will repair itself in one or two layers. Intrauterine balloon tamponade will be used if indicated.
Eligibility Criteria
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Inclusion Criteria
* History of previous cesarean section and anterior placenta previa
* Patients with prenatal diagnosis by ultrasound or MRI of PAS, regardless of the suspected degree of severity of the disease.
* Requirement for surgical management of placental accreta on a scheduled basis.
* Patients without active vaginal bleeding in the period immediately before surgery (Patients entering the operating room without active bleeding).
Exclusion Criteria
18 Years
55 Years
FEMALE
No
Sponsors
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Fundacion Clinica Valle del Lili
OTHER
Responsible Party
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Albaro Nieto
Gynecologist and Obstetrician
Principal Investigators
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Albaro Nieto-Calvache, MD
Role: PRINCIPAL_INVESTIGATOR
Fundacion Clinica Valle del Lili
Locations
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Fundación Valle del Lili
Cali, , Colombia
Countries
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References
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Silver RM, Landon MB, Rouse DJ, Leveno KJ, Spong CY, Thom EA, Moawad AH, Caritis SN, Harper M, Wapner RJ, Sorokin Y, Miodovnik M, Carpenter M, Peaceman AM, O'Sullivan MJ, Sibai B, Langer O, Thorp JM, Ramin SM, Mercer BM; National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network. Maternal morbidity associated with multiple repeat cesarean deliveries. Obstet Gynecol. 2006 Jun;107(6):1226-32. doi: 10.1097/01.AOG.0000219750.79480.84.
D'Antonio F, Iacovella C, Bhide A. Prenatal identification of invasive placentation using ultrasound: systematic review and meta-analysis. Ultrasound Obstet Gynecol. 2013 Nov;42(5):509-17. doi: 10.1002/uog.13194. Epub 2013 Oct 2.
Jauniaux E, Bhide A. Prenatal ultrasound diagnosis and outcome of placenta previa accreta after cesarean delivery: a systematic review and meta-analysis. Am J Obstet Gynecol. 2017 Jul;217(1):27-36. doi: 10.1016/j.ajog.2017.02.050. Epub 2017 Mar 6.
Fitzpatrick KE, Sellers S, Spark P, Kurinczuk JJ, Brocklehurst P, Knight M. The management and outcomes of placenta accreta, increta, and percreta in the UK: a population-based descriptive study. BJOG. 2014 Jan;121(1):62-70; discussion 70-1. doi: 10.1111/1471-0528.12405. Epub 2013 Aug 7.
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.
Collins SL, Alemdar B, van Beekhuizen HJ, Bertholdt C, Braun T, Calda P, Delorme P, Duvekot JJ, Gronbeck L, Kayem G, Langhoff-Roos J, Marcellin L, Martinelli P, Morel O, Mhallem M, Morlando M, Noergaard LN, Nonnenmacher A, Pateisky P, Petit P, Rijken MJ, Ropacka-Lesiak M, Schlembach D, Sentilhes L, Stefanovic V, Strindfors G, Tutschek B, Vangen S, Weichert A, Weizsacker K, Chantraine F; International Society for Abnormally Invasive Placenta (IS-AIP). Evidence-based guidelines for the management of abnormally invasive placenta: recommendations from the International Society for Abnormally Invasive Placenta. Am J Obstet Gynecol. 2019 Jun;220(6):511-526. doi: 10.1016/j.ajog.2019.02.054. Epub 2019 Mar 5.
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.
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.
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.
Nieto-Calvache AJ, Lopez-Giron MC, Messa-Bryon A, Ceballos-Posada ML, Duque-Galan M, Rios-Posada JG, Plazas-Cordoba LA, Chancy-Castano MM. Urinary tract injuries during treatment of patients with morbidly adherent placenta. J Matern Fetal Neonatal Med. 2021 Oct;34(19):3140-3146. doi: 10.1080/14767058.2019.1678135. Epub 2019 Oct 21.
Nieto-Calvache AJ, Vergara-Galliadi LM, Rodriguez F, Ordonez CA, Garcia AF, Lopez MC, Manzano R, Velasquez J, Carbonell JP, Bryon AM, Echavarria MP, Escobar MF, Carvajal J, Benavides-Calvache JP, Burgos JM. A multidisciplinary approach and implementation of a specialized hemorrhage control team improves outcomes for placenta accreta spectrum. J Trauma Acute Care Surg. 2021 May 1;90(5):807-816. doi: 10.1097/TA.0000000000003090.
Nieto-Calvache AJ, Lopez-Giron MC, Quintero-Santacruz M, Bryon AM, Burgos-Luna JM, Echavarria-David MP, Lopez L, Macia-Mejia C, Benavides-Calvache JP. A systematic multidisciplinary initiative may reduce the need for blood products in patients with abnormally invasive placenta. J Matern Fetal Neonatal Med. 2022 Feb;35(4):738-744. doi: 10.1080/14767058.2020.1731460. Epub 2020 Feb 23.
Nieto-Calvache AJ, Zambrano MA, Herrera NA, Usma A, Bryon AM, Benavides Calvache JP, Lopez L, Mejia M, Palacios-Jaraquemada JM. Resective-reconstructive treatment of abnormally invasive placenta: Inter Institutional Collaboration by telemedicine (eHealth). J Matern Fetal Neonatal Med. 2021 Mar;34(5):765-773. doi: 10.1080/14767058.2019.1615877. Epub 2019 May 27.
Teixidor Vinas M, Belli AM, Arulkumaran S, Chandraharan E. Prevention of postpartum hemorrhage and hysterectomy in patients with morbidly adherent placenta: a cohort study comparing outcomes before and after introduction of the Triple-P procedure. Ultrasound Obstet Gynecol. 2015 Sep;46(3):350-5. doi: 10.1002/uog.14728.
Pinas Carrillo A, Chandraharan E. Placenta accreta spectrum: Risk factors, diagnosis and management with special reference to the Triple P procedure. Womens Health (Lond). 2019 Jan-Dec;15:1745506519878081. doi: 10.1177/1745506519878081.
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.
Jauniaux E, Bhide A, Kennedy A, Woodward P, Hubinont C, Collins S; FIGO Placenta Accreta Diagnosis and Management Expert Consensus Panel. FIGO consensus guidelines on placenta accreta spectrum disorders: Prenatal diagnosis and screening. Int J Gynaecol Obstet. 2018 Mar;140(3):274-280. doi: 10.1002/ijgo.12408. No abstract available.
Jha P, Poder L, Bourgioti C, Bharwani N, Lewis S, Kamath A, Nougaret S, Soyer P, Weston M, Castillo RP, Kido A, Forstner R, Masselli G. Society of Abdominal Radiology (SAR) and European Society of Urogenital Radiology (ESUR) joint consensus statement for MR imaging of placenta accreta spectrum disorders. Eur Radiol. 2020 May;30(5):2604-2615. doi: 10.1007/s00330-019-06617-7. Epub 2020 Feb 10.
Nieto-Calvache AJ, Aryananda RA, Palacios-Jaraquemada JM, Cininta N, Grace A, Benavides-Calvache JP, Campos CI, Messa-Bryon A, Vallecilla L, Sarria D, Galindo JS, Galindo-Velasco V, Rivera-Torres LF, Burgos-Luna JM, Bhide A. One-step conservative surgery vs hysterectomy for placenta accreta spectrum: a feasibility randomized controlled trial. Am J Obstet Gynecol MFM. 2024 Jun;6(6):101333. doi: 10.1016/j.ajogmf.2024.101333. Epub 2024 Mar 6.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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1751
Identifier Type: -
Identifier Source: org_study_id
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