Delivery Outcomes by AIDA (Artificial Intelligence Dystocia Algorithm) Analysis
NCT ID: NCT06664112
Last Updated: 2024-12-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
1000 participants
OBSERVATIONAL
2024-09-30
2026-06-30
Brief Summary
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Primary aim is to investigate outcomes of eutocic labor, evaluating intrapartum ultrasound parameters by AIDA method: Angle of progression (AoP), Asynclitism degree (AD), fetal head-symphysis distance (HSD), and midline angle (MLA).
Secondary aim is to investigate outcomes of dystocic labor, evaluating intrapartum ultrasound parameters by AIDA method: Angle of progression (AoP), Asynclitism degree (AD), fetal head-symphysis distance (HSD), and midline angle (MLA).
Tertiary aim is to investigate of neonatal outcomes of eutocic labor: Apgar scores at 1 min, Apgar scores at 5 min.
Quaternary aim is to investigate of neonatal outcomes of dystocic labor: Apgar scores at 1 min, Apgar scores at 5 min.
Detailed Description
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Currently, the Artificial Intelligence Dystocia Algorithm (AIDA) represents a significant advancement in the application of artificial intelligence to intrapartum care. Developed through two key studies, AIDA 1 and AIDA 2, this innovative novel approach combines and integrates multiple geometric parameters measured through intrapartum ultrasonography with machine learning techniques and algorithms to assess labor progress and predict delivery outcomes. The selection of algorithms, methodologies for performance evaluation, and the metrics employed were meticulously delineated in the respective publications on AIDA 1 and AIDA 2. These seminal papers provide comprehensive elucidations of the machine learning techniques utilized, the rationale underpinning their selection, and the rigorous performance metrics applied to assess their efficacy in predicting labor outcomes. The high values obtained demonstrate the robust discriminative capability of the algorithms chosen in distinguishing between different delivery outcomes, underscoring the potential clinical utility of the AIDA approach in obstetric decision-making.
The AIDA Methodology A two-step methodology was applied to the data sample. The initial step, the correlation analysis, employed Pearson's correlation coefficient to ascertain that the four geometric parameters exhibited negligible or statistically insignificant correlations, ensuring each parameter contributed unique information regarding labor progression. The subsequent step, the machine learning algorithm selection, involved applying diverse supervised machine learning algorithms to the four geometric parameters in conjunction with physician-determined delivery outcomes. The predictive performance of each algorithm was quantified to identify the most efficacious models.
The AIDA Classification System The classification system is predicated upon the identification of cut-off values for each geometric parameter associated with intrapartum cesarean delivery (ICD) and non-ICD outcomes. A decision tree algorithm was utilized to establish these cut-offs: for each parameter, values strongly associated with non-ICD outcomes were designated as "green", those highly correlated with ICD were classified as "red", and in cases where the data sample revealed intermediate ranges of uncertainty, a "yellow" designation was applied.
Having assigned a color to each individual value for the four geometric parameters for every parturition, the AIDA classification system employs a structured approach to categorizing each labor event into one of five distinct classes. This color-coded stratification of the geometric parameters facilitates a nuanced assessment of labor progression, enabling a more refined classification of each case. AIDA class 0 denotes all four parameters being within the green zone, indicating a high probability of non-ICD outcomes. AIDA class 1 indicates one parameter being in the red or yellow zone and three being in the green zone. AIDA class 2 signifies two parameters being in the red or yellow zone and two being in the green zone. AIDA class 3 represents three parameters being in the red or yellow zone and one being in the green zone. AIDA class 4 denotes all four parameters being within the red or yellow zone, suggesting a heightened likelihood of ICD.
The AIDA's Prediction Performance The integration of the delivery predictions obtained from the three best performing algorithms with the AIDA classification system yielded significantly improved results. A particularly salient finding was the algorithm's high predictive accuracy for delivery outcomes, notably in AIDA classes 0 and 4. In AIDA class 0, characterized by all geometric parameters being within the green zone, the consistent prediction of non-ICD outcomes suggests its potential utility in identifying cases where intervention may be safely deferred. Conversely, the accurate prediction of ICD in AIDA class 4 cases could expedite decision-making for cesarean delivery, potentially optimizing maternal and fetal out-comes by mitigating the duration of prolonged, unproductive labor. The final methodological step entails employing the most effective machine learning algorithms for predicting delivery outcomes based on the four geometric parameters' values with consideration of the relevant AIDA class. This approach enables clinicians to evaluate a pre-diction's clinical reliability.
The remarkable predictive accuracy, particularly at the extremes of the AIDA classification spectrum, underscores the potential of this algorithmic approach to enhance clinical decision-making in labor management.
Potential Advantages of the AIDA in Dystocic Labor Management Dystocic labor, also known as dystocia, broadly defined as difficult or obstructed labor, encompasses a range of conditions that impede the normal progression of labor and delivery as forms of difficult labor characterized by abnormally slow progress.
This condition can arise due to inefficient uterine contractions, abnormal fetal presentation, or other complications that impede the normal process of childbirth. Dystocia can lead to obstructed labor, where despite strong uterine contractions, the fetus cannot descend through the birth canal due to an insurmountable barrier, often occurring at the pelvic brim.
Several types of dystocia have been recognized in obstetrics, each with characteristics and management implications, and the classification may vary slightly depending on the medical literature or clinical approach: geometric dystocia, mechanical dystocia, dynamic dystocia, fetal dystocia, uterine dystocia, functional dystocia, soft tissue dystocia, compound presentations, maternal exhaustion dystocia, and labor dystocia.
Through its simultaneous measurement of four geometric parameters-the angle of progression, asynclitism degree, head-symphysis distance, and midline angle-the AIDA offers a comprehensive view of the spatial relationships between the fetus and the maternal pelvis, provides an objective assessment of the fetal position, and holds potential as a comprehensive tool for evaluating, directly or indirectly, various types of dystocia documented in the medical literature.
This approach provides a more detailed and accurate picture of the progress of labor or labor obstruction that might be missed by traditional assessment methods. By quantifying parameters like the degree of asynclitism, the AIDA may enable earlier detection of fetal malpositions that could lead to dystocia.
The AIDA classification system offers a nuanced approach to risk assessment, helping clinicians tailor their management strategies.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Labor
The women will be followed until and after the birth, under intrapartum ultrasound monitoring, with all clinical, ultrasonographic and obstetric parameters, analyzed by AIDA method.
AIDA Analysis
The women will be followed until and after the birth, under intrapartum ultrasound monitoring, with all clinical, ultrasonographic and obstetric parameters, analyzed by AIDA method.
Interventions
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AIDA Analysis
The women will be followed until and after the birth, under intrapartum ultrasound monitoring, with all clinical, ultrasonographic and obstetric parameters, analyzed by AIDA method.
Eligibility Criteria
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Inclusion Criteria
1. pregnants in labor, at first pregnancy
2. gestational age ≥37 weeks of gestation
Exclusion Criteria
2. Patients in premature labor.
3. Patients who do not agree to participate in the study.
5. Missing data relevant for the study.
20 Years
45 Years
FEMALE
Yes
Sponsors
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Centro di Ricerca Clinica Salentino
NETWORK
Responsible Party
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Principal Investigators
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Andrea Tinelli, MD
Role: STUDY_DIRECTOR
Veris delli Ponti Hospital Scorrano, 73020 Lecce, Italy
Locations
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Ospedale Veris delli Ponti
Scorrano, Lecce, Italy
Andrea Tinelli
Lecce, Le, Italy
Countries
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Central Contacts
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Facility Contacts
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References
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Obstetric care consensus no. 1: safe prevention of the primary cesarean delivery. Obstet Gynecol. 2014 Mar;123(3):693-711. doi: 10.1097/01.AOG.0000444441.04111.1d.
Kissler K, Hurt KJ. The Pathophysiology of Labor Dystocia: Theme with Variations. Reprod Sci. 2023 Mar;30(3):729-742. doi: 10.1007/s43032-022-01018-6. Epub 2022 Jul 11.
LeFevre NM, Krumm E, Cobb WJ. Labor Dystocia in Nulliparous Women. Am Fam Physician. 2021 Jan 15;103(2):90-96.
Akmal S, Paterson-Brown S. Malpositions and malpresentations of the foetal head. Obstet Gynaecol Reprod Med. 2009 Sep 1;19(9):240-6.
Malvasi A, Barbera A, Di Vagno G, Gimovsky A, Berghella V, Ghi T, Di Renzo GC, Tinelli A. Asynclitism: a literature review of an often forgotten clinical condition. J Matern Fetal Neonatal Med. 2015 Nov;28(16):1890-4. doi: 10.3109/14767058.2014.972925. Epub 2014 Oct 29.
Buchmann EJ, Libhaber E. Sagittal suture overlap in cephalopelvic disproportion: blinded and non-participant assessment. Acta Obstet Gynecol Scand. 2008;87(7):731-7. doi: 10.1080/00016340802179848.
Hung CMW, Chan VYT, Ghi T, Lau W. Asynclitism in the second stage of labor: prevalence, associations, and outcome. Am J Obstet Gynecol MFM. 2021 Sep;3(5):100437. doi: 10.1016/j.ajogmf.2021.100437. Epub 2021 Jul 1.
Malvasi A, Vinciguerra M, Lamanna B, Cascardi E, Damiani GR, Muzzupapa G, Kosmas I, Beck R, Falagario M, Vimercati A, Cicinelli E, Trojano G, Tinelli A, Cazzato G, Dellino M. Asynclitism and Its Ultrasonographic Rediscovery in Labor Room to Date: A Systematic Review. Diagnostics (Basel). 2022 Nov 30;12(12):2998. doi: 10.3390/diagnostics12122998.
Chan VYT, Lau WL. Intrapartum ultrasound and the choice between assisted vaginal and cesarean delivery. Am J Obstet Gynecol MFM. 2021 Nov;3(6S):100439. doi: 10.1016/j.ajogmf.2021.100439. Epub 2021 Jun 30.
Malvasi A, Tinelli A, Barbera A, Eggebo TM, Mynbaev OA, Bochicchio M, Pacella E, Di Renzo GC. Occiput posterior position diagnosis: vaginal examination or intrapartum sonography? A clinical review. J Matern Fetal Neonatal Med. 2014 Mar;27(5):520-6. doi: 10.3109/14767058.2013.825598. Epub 2013 Sep 13.
Bellussi F, Ghi T, Youssef A, Salsi G, Giorgetta F, Parma D, Simonazzi G, Pilu G. The use of intrapartum ultrasound to diagnose malpositions and cephalic malpresentations. Am J Obstet Gynecol. 2017 Dec;217(6):633-641. doi: 10.1016/j.ajog.2017.07.025. Epub 2017 Jul 22.
Skinner SM, Giles-Clark HJ, Higgins C, Mol BW, Rolnik DL. Prognostic accuracy of ultrasound measures of fetal head descent to predict outcome of operative vaginal birth: a comparative systematic review and meta-analysis. Am J Obstet Gynecol. 2023 Jul;229(1):10-22.e10. doi: 10.1016/j.ajog.2022.11.1294. Epub 2022 Nov 23.
Gimovsky AC. Defining arrest in the first and second stages of labor. Minerva Obstet Gynecol. 2021 Feb;73(1):6-18. doi: 10.23736/S2724-606X.20.04644-4. Epub 2020 Sep 3.
Pergialiotis V, Bellos I, Antsaklis A, Papapanagiotou A, Loutradis D, Daskalakis G. Maternal and neonatal outcomes following a prolonged second stage of labor: A meta-analysis of observational studies. Eur J Obstet Gynecol Reprod Biol. 2020 Sep;252:62-69. doi: 10.1016/j.ejogrb.2020.06.018. Epub 2020 Jun 10.
Ben-Haroush A, Melamed N, Kaplan B, Yogev Y. Predictors of failed operative vaginal delivery: a single-center experience. Am J Obstet Gynecol. 2007 Sep;197(3):308.e1-5. doi: 10.1016/j.ajog.2007.06.051.
Ghi T, Youssef A, Maroni E, Arcangeli T, De Musso F, Bellussi F, Nanni M, Giorgetta F, Morselli-Labate AM, Iammarino MT, Paccapelo A, Cariello L, Rizzo N, Pilu G. Intrapartum transperineal ultrasound assessment of fetal head progression in active second stage of labor and mode of delivery. Ultrasound Obstet Gynecol. 2013 Apr;41(4):430-5. doi: 10.1002/uog.12379.
Ghi T, Eggebo T, Lees C, Kalache K, Rozenberg P, Youssef A, Salomon LJ, Tutschek B. ISUOG Practice Guidelines: intrapartum ultrasound. Ultrasound Obstet Gynecol. 2018 Jul;52(1):128-139. doi: 10.1002/uog.19072.
Rizzo G, Ghi T, Henrich W, Tutschek B, Kamel R, Lees CC, Mappa I, Kovalenko M, Lau W, Eggebo T, Achiron R, Sen C. Ultrasound in labor: clinical practice guideline and recommendation by the WAPM-World Association of Perinatal Medicine and the PMF-Perinatal Medicine Foundation. J Perinat Med. 2022 May 27;50(8):1007-1029. doi: 10.1515/jpm-2022-0160. Print 2022 Oct 26.
Nassr AA, Berghella V, Hessami K, Bibbo C, Bellussi F, Robinson JN, Marsoosi V, Tabrizi R, Safari-Faramani R, Tolcher MC, Shamshirsaz AA, Clark SL, Belfort MA, Shamshirsaz AA. Intrapartum ultrasound measurement of angle of progression at the onset of the second stage of labor for prediction of spontaneous vaginal delivery in term singleton pregnancies: a systematic review and meta-analysis. Am J Obstet Gynecol. 2022 Feb;226(2):205-214.e2. doi: 10.1016/j.ajog.2021.07.031. Epub 2021 Aug 9.
Malvasi A, Malgieri LE, Cicinelli E, Vimercati A, D'Amato A, Dellino M, Trojano G, Difonzo T, Beck R, Tinelli A. Artificial Intelligence, Intrapartum Ultrasound and Dystocic Delivery: AIDA (Artificial Intelligence Dystocia Algorithm), a Promising Helping Decision Support System. J Imaging. 2024 Apr 29;10(5):107. doi: 10.3390/jimaging10050107.
Malvasi A, Malgieri LE, Cicinelli E, Vimercati A, Achiron R, Sparic R, D'Amato A, Baldini GM, Dellino M, Trojano G, Beck R, Difonzo T, Tinelli A. AIDA (Artificial Intelligence Dystocia Algorithm) in Prolonged Dystocic Labor: Focus on Asynclitism Degree. J Imaging. 2024 Aug 9;10(8):194. doi: 10.3390/jimaging10080194.
Related Links
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Malvasi A, Gustapane S, Malvasi M, Vinciguerra M, Tinelli A, Beck R. Semeiotics of Intrapartum Ultrasonography: New Diagnostic Sonographic Sign of Fetal Malpositions and Malrotations.
Malgieri, L.E. Ontologies, Machine Learning and Deep Learning in Obstetrics. In Practical Guide to Simulation in Delivery Room Emergencies; Cinnella, G., Beck, R., Malvasi, A., Eds.; Springer: Cham, Switzerland, 2023.
Other Identifiers
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CER 0320
Identifier Type: -
Identifier Source: org_study_id