Clinical trial NCT06219564: Total Placenta Previa Associated With the Placenta Accreta Spectrum.
Official title: Diagnostic Accuracy of MRI to Predict Peripartum Hysterectomy and Neonatal Mortality in Total Placenta Previa: A Retrospective Cohort Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Maternal; Procedure
Keywords: magnetic resonance imaging
obstetric labor complications
placenta percreta
placenta previa
pregnancy complications
Lead sponsor: Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
Sponsor class: OTHER
First posted: 2024-01-23
Enrollment: 277
Sex: FEMALE
Minimum age (years): 17
Maximum age (years): 42
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 277 singleton pregnancies that met the inclusion criteria and were diagnosed with total placenta previa (t-PP) in the third trimester were divided into two groups according to whether a placental-MRI (p-MRI) was performed. Nevertheless, we explored whether pregnant women diagnosed with total placenta previa (t-PP), with or without a placental-MRI (p-MRI), needed to undergo peripartum-total abdominal hysterectomy (p-TAH) during cesarean section (C/S) due to the placenta accreta spectrum (PAS).
Primary purpose: DIAGNOSTIC

Brief summary: To assess the reliability of placental magnetic resonance imaging measurements in predicting peripartum hysterectomy and neonatal outcomes in patients with total placenta previa.

Detailed description: Study design and patients This study analyzed the outcomes of a cohort of 372 pregnant women diagnosed with PP over five years, from November 2017 to June 2023. The patient population for the study included women between the ages of 17 and 42 who were in their third trimester of pregnancy (27th to 37th weeks of gestation) and had received a t-PP diagnosis via color Doppler ultrasonography (cd-USG) and/or p-MRI. The resulting cohort compared a final sample population of 277 singleton pregnant women with t-PP, which comprised 150 pregnant women who underwent antenatal p-MRI examinations in the third trimester and 127 pregnant women who did not undergo a p-MRI.

Standards of reference The study covered all singleton pregnancies in which t-PP extended to both the anterior and posterior uterine walls, resulting in complete coverage of the internal cervical os by the placenta. Transvaginal and transabdominal USG were planned between 32 and 34 weeks for all patients who were followed up in our clinic due to t-PP and were scheduled to be delivered. The gestational ages of the participants were determined using the last menstrual date and crown-rump length (CRL) measurements from a first-trimester ultrasound. Two perinatologists with at least ten years of experience examined each patient's cd-USG for signs of PAS. Ultrasonographic signs identified included placental lacunae, placenta previa involving the cervix, loss of the clear zone, and bladder wall interruption.

Two radiologists with at least ten years of experience, independently of each other, evaluated p-MRI scans of pregnant women diagnosed with t-PP without prior knowledge of the original reports.

Definitive diagnosis and pathological reporting Pathological reports and approvals were granted according to a rigorous protocol involving at least two pathologists, each with a minimum of seven years of professional expertise in their field.

p-MRI image interpretations The assessment focused on analyzing the different positions of the atypical placenta in the lower uterine segment, including the anterior, posterior, anterolateral, and posterolateral locations. Precise measurements were taken to calculate the placental volume in the S1 and S2 sectors, cervical canal length, and cervical canal dilatation. Based on sagittal p-MRI scans, the placental invasion was classified into two main areas. Implementing a plane perpendicular to the upper bladder's axis facilitated the boundary of these sectors. The term S1 refers to the upper uterine segment that forms the part of the uterus that contacts the bladder's posterior wall. Likewise, the lower uterine segment, identified as S2, was formed in the lower posterior wall of the bladder. Radiologists conducted a sector-wise (S1 and S2) examination of the invasion topography, which allowed them to identify specific invasion locations, including parametrial and cervical involvement and bladder interruption.

Multidisciplinary team The operations of patients who gave birth due to PAS were performed by the same multidisciplinary team, which included perinatologists, gynecological and obstetric surgeons, gynecological oncologists, urologists, neonatologists, cardiovascular surgeons, anesthesiology and reanimation specialists, interventional radiologists, and allied health personnel with ten years of experience.

Scheduled surgery and preoperative preparations All participants in our study underwent cesarean births during the third trimester of pregnancy. Except for urgent situations, all scheduled preterm cesarean deliveries and p-TAH procedures were conducted during the gestational period of 34+0 to 36+6 weeks. Among the patients admitted to our clinic due to t-PP, surgical intervention was performed before the planned delivery date in cases of uterine contraction, the onset of vaginal bleeding, or unexpected medical indications for the mother and fetus.

Statistical Method and Power Analysis G\*Power V. 3.1.9.6 estimated sample size. All p-MRI values of patients with and without PAS were compared in the reference study, and the difference was substantial. Using 95% confidence (1-α), 95% test power (1-β), d=0.8 effect size, and the two-way hypothesis, the study contained 84 cases, with a minimum of 42 in each group. The study included 155 cesarean sections and 122 TAH cases; post hoc analysis revealed a power of 99.9%. 16 Data were analyzed using IBM SPSS V23. ROC analysis determined the surgical procedure variable cut-off values. Univariate and multivariate binary logistic regression analyses examined independent surgical risk factors. Backward-Wald method was used for multivariate binary logistic regression. The analysis findings present mean ± standard deviation, median (minimum-maximum), and frequency (percentage) for quantitative and categorical variables. Intraclass correlation coefficients and Kappa (k) tests were conducted to assess intra- and inter-observer agreement reliability. The significance level was set at p\<0.05.

Eligibility criteria: Inclusion Criteria:

* 27th to 37th weeks of gestation
* Third trimester of pregnancy
* Pregnants had received a t-PP diagnosis via color Doppler ultrasonography (cd-USG) and/or placental MRI (p-MRI).
* All singleton pregnancies in which t-PP extended to both the anterior and posterior uterine walls, resulting in complete coverage of the internal cervical os by the placenta

Exclusion Criteria:

* Any cases of low-lying/marginal placenta previa
* Preoperative hemoglobin level \< 9 g/dL
* Pregnant women with coagulation disorders
* Morbid obesity
* Multiple fetal pregnancies
* Individuals delivered before \< 27 weeks of gestation

Primary outcomes:
measure: Assessment of risk factors affecting peripartum hysterectomy in placenta previa patients undergoing without MRI screening
timeFrame: Assessed during the peripartum period, within the first two days postpartum.
measure: Clinical risk factors affecting p-TAH in patients with t-PP undergoing p-MRI.
timeFrame: Assessed during the peripartum period, within the first 2 days postpartum.
measure: Identification of risk factors affecting neonatal mortality regardless of whether MRI scanning is used.
timeFrame: Assessed at the time of delivery.
Secondary outcomes:
measure: The ROC analysis of the placental volume (S1 and S2 sectors), CCL, and CCD obtained from the p-MRI scan for indications of peripartum hysterectomy
timeFrame: Assessed based on ROC analysis.
measure: Peripartum Hysterectomy Occurrence
timeFrame: Assessed during the peripartum period, within the first 2 days postpartum.
Other outcomes:
Locations:
city: Adana
country: Turkey
facility: University of Health Sciences Adana City Training and Research Hospital, Department of Obstetrics and Gynecology
state: Yüreğir
Study officials:
affiliation: SBU Adana Training and Research Hospital, Department of Obstetrics and Gynecology, Adana, Turkey
name: Sadık Kükrer
role: PRINCIPAL_INVESTIGATOR
affiliation: SBU Adana Training and Research Hospital, Department of Obstetrics and Gynecology, Adana, Turkey
name: Sefa Arlıer
role: STUDY_CHAIR
affiliation: SBU Adana Training and Research Hospital, Department of Radiology, Adana, Turkey
name: Okan Dilek
role: STUDY_CHAIR
affiliation: Yuksek Ihtisas University, Department of Obstetrics and Gynecology, Ankara, Turkey
name: Çağrı Gülümser
role: STUDY_DIRECTOR
affiliation: SBU Adana Training and Research Hospital, Department of Obstetrics and Gynecology, Adana, Turkey
name: Işıl Adıgüzel
role: STUDY_CHAIR
References:
citation: Huijgen QC, Gijsen AF, Hink E, Van Kesteren PJ. Cervical tourniquet in case of uncontrollable haemorrhage during caesarean section owing to a placenta accreta. BMJ Case Rep. 2013 Apr 22;2013:bcr2013009237. doi: 10.1136/bcr-2013-009237.
citation: 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.
citation: Morel O, Collins SL, Uzan-Augui J, Masselli G, Duan J, Chabot-Lecoanet AC, Braun T, Langhoff-Roos J, Soyer P, Chantraine F; International Society for Abnormally Invasive Placenta (IS-AIP). A proposal for standardized magnetic resonance imaging (MRI) descriptors of abnormally invasive placenta (AIP) - From the International Society for AIP. Diagn Interv Imaging. 2019 Jun;100(6):319-325. doi: 10.1016/j.diii.2019.02.004. Epub 2019 Mar 8.
citation: Palacios Jaraquemada JM, Bruno CH. Magnetic resonance imaging in 300 cases of placenta accreta: surgical correlation of new findings. Acta Obstet Gynecol Scand. 2005 Aug;84(8):716-24. doi: 10.1111/j.0001-6349.2005.00832.x.
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.
citation: Jauniaux E, Hussein AM, Fox KA, Collins SL. New evidence-based diagnostic and management strategies for placenta accreta spectrum disorders. Best Pract Res Clin Obstet Gynaecol. 2019 Nov;61:75-88. doi: 10.1016/j.bpobgyn.2019.04.006. Epub 2019 Apr 30.
citation: Hecht JL, Baergen R, Ernst LM, Katzman PJ, Jacques SM, Jauniaux E, Khong TY, Metlay LA, Poder L, Qureshi F, Rabban JT 3rd, Roberts DJ, Shainker S, Heller DS. Classification and reporting guidelines for the pathology diagnosis of placenta accreta spectrum (PAS) disorders: recommendations from an expert panel. Mod Pathol. 2020 Dec;33(12):2382-2396. doi: 10.1038/s41379-020-0569-1. Epub 2020 May 15.
citation: Hobson SR, Kingdom JC, Murji A, Windrim RC, Carvalho JCA, Singh SS, Ziegler C, Birch C, Frecker E, Lim K, Cargill Y, Allen LM. No. 383-Screening, Diagnosis, and Management of Placenta Accreta Spectrum Disorders. J Obstet Gynaecol Can. 2019 Jul;41(7):1035-1049. doi: 10.1016/j.jogc.2018.12.004.
citation: Romeo V, Verde F, Sarno L, Migliorini S, Petretta M, Mainenti PP, D'Armiento M, Guida M, Brunetti A, Maurea S. Prediction of placenta accreta spectrum in patients with placenta previa using clinical risk factors, ultrasound and magnetic resonance imaging findings. Radiol Med. 2021 Sep;126(9):1216-1225. doi: 10.1007/s11547-021-01348-6. Epub 2021 Jun 22.
citation: 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.
citation: Chen X, Shan R, Song Q, Wei X, Liu W, Wang G. Placenta percreta evaluated by MRI: correlation with maternal morbidity. Arch Gynecol Obstet. 2020 Mar;301(3):851-857. doi: 10.1007/s00404-019-05420-5. Epub 2020 Jan 4.
citation: Gulati A, Anand R, Aggarwal K, Agarwal S, Tomer S. Ultrasound as a Sole Modality for Prenatal Diagnosis of Placenta Accreta Spectrum: Potentialities and Pitfalls. Indian J Radiol Imaging. 2021 Oct 19;31(3):527-538. doi: 10.1055/s-0041-1735864. eCollection 2021 Jul.
citation: Bhide A, Laoreti A, Kaelin Agten A, Papageorghiou A, Khalil A, Uprichard J, Thilaganathan B, Chandraharan E. Lower uterine segment placental thickness in women with abnormally invasive placenta. Acta Obstet Gynecol Scand. 2019 Jan;98(1):95-100. doi: 10.1111/aogs.13422. Epub 2018 Aug 2.
citation: Elmaraghy AM, Taha Fayed S, Abd ElHamid Ali M, Ali Hassanien M, Mohamed Mamdouh A. Diagnostic Accuracy of Placental Thickness in Lower Uterine Segment Measured by Ultrasound in Prediction of Placenta Accreta Spectrum in Patients with Placenta Previa. A Diagnostic Test Accuracy Study. Int J Womens Health. 2023 Feb 16;15:311-320. doi: 10.2147/IJWH.S399520. eCollection 2023.
citation: Takahashi H, Matsubara S. Placental thickness measurement is difficult in some cases. Acta Obstet Gynecol Scand. 2019 Feb;98(2):264-265. doi: 10.1111/aogs.13443. Epub 2018 Sep 12. No abstract available.
citation: Altal OF, Qudsieh S, Ben-Sadon A, Hatamleh A, Bataineh A, Halalsheh O, Amarin Z. Cervical tourniquet during cesarean section to reduce bleeding in morbidly adherent placenta: a pilot study. Future Sci OA. 2022 Mar 8;8(4):FSO789. doi: 10.2144/fsoa-2021-0087. eCollection 2022 Apr.
citation: Matsuzaki S, Nagase Y, Takiuchi T, Kakigano A, Mimura K, Lee M, Matsuzaki S, Ueda Y, Tomimatsu T, Endo M, Kimura T. Antenatal diagnosis of placenta accreta spectrum after in vitro fertilization-embryo transfer: a systematic review and meta-analysis. Sci Rep. 2021 Apr 28;11(1):9205. doi: 10.1038/s41598-021-88551-7.
citation: Salmanian B, Fox KA, Arian SE, Erfani H, Clark SL, Aagaard KM, Detlefs SE, Aalipour S, Espinoza J, Nassr AA, Gibbons WE, Shamshirsaz AA, Belfort MA, Shamshirsaz AA. In vitro fertilization as an independent risk factor for placenta accreta spectrum. Am J Obstet Gynecol. 2020 Oct;223(4):568.e1-568.e5. doi: 10.1016/j.ajog.2020.04.026. Epub 2020 Apr 30.
citation: Vermey BG, Buchanan A, Chambers GM, Kolibianakis EM, Bosdou J, Chapman MG, Venetis CA. Are singleton pregnancies after assisted reproduction technology (ART) associated with a higher risk of placental anomalies compared with non-ART singleton pregnancies? A systematic review and meta-analysis. BJOG. 2019 Jan;126(2):209-218. doi: 10.1111/1471-0528.15227. Epub 2018 May 8.
citation: Imafuku H, Tanimura K, Shi Y, Uchida A, Deguchi M, Terai Y. Clinical factors associated with a placenta accreta spectrum. Placenta. 2021 Sep 1;112:180-184. doi: 10.1016/j.placenta.2021.08.001. Epub 2021 Aug 5.