- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05013749
Histerectomy Vs Partial Myometrial Resection for Placenta Accreta Spectrum (RCT-PAS)
Hysterectomy Vs Partial Myometrial Resection for Placenta Accreta Spectrum (PAS). A Feasibility Study of a Randomized Controlled Clinical Experiment (RCT-PAS)
Currently, Placenta Accreta Spectrum (PAS) has two treatment options: hysterectomy (completely removing the uterus) and partial myometrial resection (resecting the part of the uterus affected by this pathology).
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Cali, Colombia
- Fundación Valle Del Lili
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Pregnant women over 18 years of age.
- 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:
- Women without previous living children.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 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: 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
|
Active Comparator: 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: 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportion of eligible patients who agree to participate in the study.
Time Frame: 24 months
|
Number of patients who agree to participate, out of the total number of eligible patients
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24 months
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Screening failure percentage
Time Frame: 24 months
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Percentage of patients who entered the study but did not present macroscopic findings of placenta accreta spectrum during laparotomy.
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24 months
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Percentage of patients with crossover between assigned study arms.
Time Frame: 24 months
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Percentage of patients who were assigned to the partial myometrial resection arm, however, due to the severity of the injury or another factor, had to perform a hysterectomy.
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24 months
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Number of participants who completed the follow-up evaluation.
Time Frame: 24 months
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Number of participants who completed the follow-up evaluation.
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24 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maternal death
Time Frame: 24 months
|
Number of maternal deaths during the study period
|
24 months
|
Intra-surgical bleeding volume measured in mililiters
Time Frame: During surgery
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Surgical bleeding calculated in milliliters
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During surgery
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Blood component transfusion requirement
Time Frame: Up to 42 days postpartum
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If during hospitalization the patient required transfusion of some type of blood component
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Up to 42 days postpartum
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median transfusion of red blood cell units (RBCU)
Time Frame: Up to 42 days postpartum
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Median number of units of red blood cells transfused
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Up to 42 days postpartum
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Number of patients who met at least 1 Near Miss criterion
Time Frame: Up to 42 days postpartum
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Number of patients who met at least 1 Near Miss criterion
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Up to 42 days postpartum
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Number of patients who had ureteral injuries
Time Frame: Up to 42 days postpartum
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Number of patients who had ureteral injuries
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Up to 42 days postpartum
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Number of patients who had Bladder injuries
Time Frame: Up to 42 days postpartum
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Number of patients who had Bladder injuries
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Up to 42 days postpartum
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Number of patients who need surgical reoperation.
Time Frame: Up to 42 days postpartum
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Number of patients who need surgical reoperation after index surgery
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Up to 42 days postpartum
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Number of patients who were admitted to the Intensive Care Unit.
Time Frame: Up to 42 days postpartum
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Number of patients that required management in the Intensive Care Unit
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Up to 42 days postpartum
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Number of days of postoperative hospital stay.
Time Frame: Up to 42 days postpartum
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Number of days of hospital stay after index surgery
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Up to 42 days postpartum
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Albaro Nieto-Calvache, MD, Fundacion Clinica Valle del Lili
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1751
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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