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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.
Placenta accreta spectrum is a serious condition associated with significant maternal morbidity and even mortality. The recommended treatment is hysterectomy. An alternative is 1-step conservative surgery, which involves the en bloc resection of the myometrium affected by placenta accreta spectrum along with the placenta, followed by uterine reconstruction. Currently, there are no studies comparing the 2 techniques in the setting of a randomized controlled trial.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Maternal Death | Number of maternal deaths during the study period | 6 weeks |
| Intra-surgical Bleeding Volume | Surgical bleeding calculated in milliliters |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Albaro Nieto-Calvache, MD | Fundacion Clinica Valle del Lili | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fundación Valle del Lili | Cali | Colombia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16738145 | Background | 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. | |
| 23943408 |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Count of Participants | Participants | 6 weeks |
|
|
Follow up to 42 days (6 weeks) postpartum.
Five of the 8 women with adverse events were randomized to OSCS, but in 4 of them intraoperative staging led to an immediate crossover to hysterectomy, and OSCS was not attempted.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Adverse event | Surgical and medical procedures | Systematic Assessment | Adverse Events were monitored/assessed without regard to the specific Adverse Event Term. Bleeding >2.5 L or other situation that prolonged hospitalization, motivated reoperation or rehospitalization, or put life at risk |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Albaro José Nieto Calvache | Fundación Valle del Lili | (+57) 6023319090 | 3056 - 305 | albaro.nieto@fvl.org.co |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 20, 2021 | Oct 18, 2022 | Prot_SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 15, 2021 | Jul 22, 2021 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D010921 | Placenta Accreta |
| ID | Term |
|---|---|
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D007044 | Hysterectomy |
| ID | Term |
|---|---|
| D013509 | Gynecologic Surgical Procedures |
| D013519 | Urogenital Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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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.
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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
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|
| 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. |
|
| During surgery |
| Blood Component Transfusion Requirement | If during hospitalization the patient required transfusion of some type of blood component | Up to 42 days postpartum |
| Median Transfusion of Red Blood Cell Units (RBCU) | Median number of units of red blood cells transfused | Up to 42 days postpartum |
| Number of Patients Who Met at Least 1 Near Miss Criterion | Situation or indicator that almost led to a serious adverse event but did not actually result in harm. For this study, the event was cardiac arrest with successful resuscitation. | Up to 42 days postpartum |
| Number of Patients Who Had Bladder Injuries | Number of patients who had intraoperative bladder injuries. | Up to 42 days postpartum |
| Number of Patients Who Need Surgical Reoperation. | Number of patients who need surgical reoperation after index surgery | Up to 42 days postpartum |
| Number of Patients Who Were Admitted to the Intensive Care Unit. | Number of patients that required management in the Intensive Care Unit | Up to 42 days postpartum |
| Number of Days of Postoperative Hospital Stay. | Number of days of hospital stay after index surgery | Up to 42 days postpartum |
| Background |
| 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. |
| 28268196 | Background | 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. |
| 23924326 | Background | 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. |
| 30153754 | Background | 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. |
| 30849356 | 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. |
| 31984808 | Background | 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. |
| 29405317 | Background | 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. |
| 29405320 | Background | 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. |
| 31631730 | Background | 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. |
| 33496549 | Background | 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. |
| 32089029 | Background | 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. |
| 31057039 | Background | 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. |
| 25402727 | Background | 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. |
| 31578123 | Background | 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. |
| 31173360 | Background | 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. |
| 29405319 | Background | 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. |
| 32040730 | Background | 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. |
| 38458362 | Derived | 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. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Body mass index | Units used to assess Body mass index kg/m^2 | Number | kg/m^2 |
|
| Number of previous pregnancies | Number | number of previous pregnancies |
|
| Number of previous cesarean sections | Count of Participants | Participants |
|
| Number of previous dilatation curettage | Count of Participants | Participants |
|
| Gestational age at the time of diagnosis of PAS | Median | Inter-Quartile Range | weeks |
|
| Diagnostic method of PAS | Count of Participants | Participants |
|
| Antepartum vaginal bleeding | Count of Participants | Participants |
|
| Comorbidity | Number | participants |
|
| Gestational age at birth | Median | Inter-Quartile Range | weeks |
|
|
|
| Primary | Screening Failure Percentage | Percentage of patients who entered the study but did not present macroscopic findings of placenta accreta spectrum during laparotomy. | Posted | Count of Participants | Participants | During surgery |
|
|
|
| Primary | 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; | Posted | Count of Participants | Participants | During surgery |
|
|
|
| Primary | Number of Participants Who Completed the Follow-up Evaluation. | Number of participants who completed follow-up at 42 days postpartum | Posted | Count of Participants | Participants | 42 days postpartum |
|
|
|
| Secondary | Maternal Death | Number of maternal deaths during the study period | Posted | Count of Participants | Participants | 6 weeks |
|
|
|
| Secondary | Intra-surgical Bleeding Volume | Surgical bleeding calculated in milliliters | Posted | Median | Inter-Quartile Range | mL | During surgery |
|
|
|
| Secondary | Blood Component Transfusion Requirement | If during hospitalization the patient required transfusion of some type of blood component | Posted | Count of Participants | Participants | Up to 42 days postpartum |
|
|
|
| Secondary | Median Transfusion of Red Blood Cell Units (RBCU) | Median number of units of red blood cells transfused | Posted | Median | Inter-Quartile Range | Number of RBCU | Up to 42 days postpartum |
|
|
|
| Secondary | Number of Patients Who Met at Least 1 Near Miss Criterion | Situation or indicator that almost led to a serious adverse event but did not actually result in harm. For this study, the event was cardiac arrest with successful resuscitation. | Posted | Count of Participants | Participants | Up to 42 days postpartum |
|
|
|
| Secondary | Number of Patients Who Had Bladder Injuries | Number of patients who had intraoperative bladder injuries. | Posted | Count of Participants | Participants | Up to 42 days postpartum |
|
|
|
| Secondary | Number of Patients Who Need Surgical Reoperation. | Number of patients who need surgical reoperation after index surgery | Posted | Count of Participants | Participants | Up to 42 days postpartum |
|
|
|
| Secondary | Number of Patients Who Were Admitted to the Intensive Care Unit. | Number of patients that required management in the Intensive Care Unit | Posted | Count of Participants | Participants | Up to 42 days postpartum |
|
|
|
| Secondary | Number of Days of Postoperative Hospital Stay. | Number of days of hospital stay after index surgery | Posted | Median | Inter-Quartile Range | Days | Up to 42 days postpartum |
|
|
|
| 0 |
| 33 |
| 3 |
| 33 |
| 0 |
| 33 |
| EG001 | 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. | 0 | 27 | 5 | 27 | 0 | 27 |
|
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| D010922 | Placenta Diseases |
| ≥3 |
|
| ≥2 |
|