Histerectomy Vs Partial Myometrial Resection for Placenta Accreta Spectrum

NCT05013749 | Completed Results DMC

• 1 other identifier: 1751
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Placenta Accreta

Keywords

Placenta accreta; Resective reconstructive treatment; Hysterectomy

Outcome Measures

Primary Outcomes (4)

• Feasibility: Proportion of Eligible Patients Who Agree to Participate in the Study.

  Number of patients who agree to participate, out of the total number of eligible patients

  6 weeks

• Screening Failure Percentage

  Percentage of patients who entered the study but did not present macroscopic findings of placenta accreta spectrum during laparotomy.

  During surgery

• Percentage of Patients With Crossover Between Assigned Study Arms.

  All patients had been randomized before surgery to a certain procedure; however, after performing intraoperative staging, it was identified that some women did not have signs of PAS (7 patients with false positive prenatal diagnosis, randomized to hysterectomy), so they were managed with OSCS, and that some women did not meet the criteria to perform OSCS (9 patients randomized to OSCS), so they were managed with hysterectomy;

  During surgery

• Number of Participants Who Completed the Follow-up Evaluation.

  Number of participants who completed follow-up at 42 days postpartum

  42 days postpartum

Secondary Outcomes (9)

• Maternal Death

  6 weeks

• Intra-surgical Bleeding Volume

  During surgery

• Blood Component Transfusion Requirement

  Up to 42 days postpartum

• Median Transfusion of Red Blood Cell Units (RBCU)

  Up to 42 days postpartum

• Number of Patients Who Met at Least 1 Near Miss Criterion

  Up to 42 days postpartum

Study Arms (2)

Hysterectomy

ACTIVE COMPARATOR

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

Procedure: Hysterectomy

Partial myometrial resection

ACTIVE COMPARATOR

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.

Procedure: Partial Myometrial Resection

Interventions

Hysterectomy PROCEDURE

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

Partial Myometrial Resection PROCEDURE

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.

Partial myometrial resection

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• Women without previous living children.

Sponsors & Collaborators

• Fundacion Clinica Valle del Lili: lead

Study Sites (1)

Fundación Valle del Lili

Cali, Colombia

Location

Related Publications (19)

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• 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.

  PMID: 30153754 BACKGROUND

• 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.

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• 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.

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• 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.

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• 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.

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• 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.

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• 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.

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• 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.

  PMID: 38458362 DERIVED

MeSH Terms

Conditions

Placenta Accreta

Interventions

Hysterectomy

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Placenta Diseases

Intervention Hierarchy (Ancestors)

Gynecologic Surgical Procedures; Urogenital Surgical Procedures; Surgical Procedures, Operative

Results Point of Contact

• Title: Albaro José Nieto Calvache
• Organization: Fundación Valle del Lili

albaro.nieto@fvl.org.co

(+57) 6023319090

Study Officials

• Albaro Nieto-Calvache, MD

  Fundacion Clinica Valle del Lili

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This is an open-label study as it is not possible to conceal the surgical procedure for each arm from the operator (Treating Physician) or from the participant
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Gynecologist and Obstetrician

Model Details: Eligible women will receive complete information about the study. If they agree to participate in it, they will sign the informed consent for both interventions: hysterectomy and partial myometrial resection. The final modality of intervention will be decided at randomization prior to the start of the surgical procedure. 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.

Study Record Dates

• First Submitted: July 22, 2021
• First Posted: August 19, 2021
• Study Start: August 20, 2021
• Primary Completion: April 17, 2023
• Study Completion: April 17, 2023
• Last Updated: November 25, 2024
• Results First Posted: November 25, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CO (1)