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AzTrials

Delivery ComplicationAIDANCT06664112

Delivery Outcomes by AIDA (Artificial Intelligence Dystocia Algorithm) Analysis

An observational study of Delivery Complication and Delivery Problem, run by Centro di Ricerca Clinica Salentino at 2 sites in Italy.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Aims: 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). Read more about this study

Who is it for?
Ages 20 to 45 years, women onlyHealthy volunteers can take part
What is being tested?
AIDA Analysis
Type of treatment
Medical device
How many people
1,000 participants
Where
2 sitesItaly
Study dates
30 Sep 2024to 30 Jun 2026
How long will I take part?
12 Months
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 45 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Study population: All healthy pregnants, at first pregnancy, in spontaneous or induced labor will be enrolled for the study, in order to better understand the outcomes of labor, monitored by intrapartum ultrasound parameters of labor assessed by AIDA method. The study will be conducted as observational study including pregnants in labor. In the collecting center, one person will be in charge for data collection and filling the SPSS database. As the study is observational and all the procedures will be conducted according to the local practice, all patients will sign an informed consent. Following data collection and termination of the study, a single researcher will oversee the SPSS data collection for all the participating centers, checking the quality of data and submitting it for statistical analysis.

Who may be able to join

  • All patients in pregnancy, nulliparae, candidates for spontaneous or induced labor, monitored by intrapartum ultrasound, collecting the ultrasound parameters of the labor progress.
  • pregnants in labor, at first pregnancy
  • gestational age ≥37 weeks of gestation

Who cannot join

  • Multiparas who are candidates for cesarean section, premature labor and patients who do not agree to participate in the study (missing data relevant for the study). Exclusion criteria encompassed: breech, transverse, or oblique presentations; twin pregnancies; abnormal placental implantation; HELLP syndrome; coagulation disorders; uterine hyperstimulation (often referred to as "terrified uterus"); non-reassuring fetal heart rate; thick meconium; and cephalopelvic disproportion.
  • Patients who are candidates for cesarean section.
  • Patients in premature labor.
  • Patients who do not agree to participate in the study.
  • Exclusion criteria encompassed: breech, transverse, or oblique presentations; twin pregnancies; abnormal placental implantation; HELLP syndrome; coagulation disorders; uterine hyperstimulation (often referred to as "terrified uterus"); non-reassuring fetal heart rate; thick meconium; and cephalopelvic disproportion
  • Missing data relevant for the study.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Andrea Tinelli, MD contact

+393392074078

andreatinelli@gmail.com

Italy2 sites, 2 recruiting
  • Andrea Tinelli

    Lecce, Le, 73100

    ANDREA TINELLI, 3392074078, andreatinelli@gmail.com

    Recruiting
  • Ospedale Veris delli Ponti

    Scorrano, Lecce, 73020

    Andrea Tinelli, MD Prof PhD, +393392074078, andreatinelli@gmail.com

    Recruiting

Other trials in Italy

About this study

Official title: Study of Delivery Outcomes After AIDA (Artificial Intelligence Dystocia Algorithm) Analysis

Aims:

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).

Read more

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.

Read the detailed description

One of the hardest processes to overcome during labor is the positioning of the fetal head during engagement and progression in the birth canal. These malpositions and malrotations are also common causes of dystocic labor and arrest of progression, which necessitates a surgical delivery. Traditionally, a vaginal digital examination is used to assess the fetal head position and engagement. The degree of fetal engagement and progression is delineated by different planes of the pelvis, which have values ranging from -5 (5 cm above the ischial spines) to +5 (5 cm below the ischial spines with the fetal head visible at the introitus). The head is considered engaged when the leading point of the skull touches the ischial spine plane; this is referred to as station 0. Moreover, when the parietal bone is the presenting feature, asynclitism is identified. When the front parietal bone manifests, the condition is identified as anterior asynclitism; when the posterior parietal bone presents, the condition is described as posterior asynclitism. The fetal head's minor "tilted" posture in the birth canal, however, is a result of the fetal head's physiological adjustment to the mother's pelvis throughout labor. Malposition and malrotation of the fetal head in the birth canal, characterized by significant asynclitism, might result in dystocia that necessitates surgical delivery. The 15% of people have asynclitism, with anterior asynclitism being more common than posterior asynclitism. The traditional classification of degree of fetal engagement and progression has been criticized as inaccurate and poorly reproducible. Furthermore, the failure of instrumental delivery, which may reach up to 10%. Errors in the diagnosis of the fetal head station can have major implications during labor and adverse perinatal outcomes, such as acidemia, fetal traumas, intracranial hemorrhages, and low Apgar scores after an emergency cesarean section for failed operative vaginal deliveries. Many researchers have proposed many ultrasonographic parameters, collected during labor and delivery, to evaluate the engagement, descent, and internal rotation of the fetal head in the birth canal. Thus, we used intrapartum ultrasound parameters, measured in all the women during labor and recorded to be measured by artificial intelligence and machine learning algorithms, called AIDA (Artificial Intelligence Dystocia Algorithm), which incorporates a human-in-the-loop approach, that is, to use AI (artificial intelligence) algorithms that prioritize the physician's decision and explainable artificial intelligence (XAI). The AIDA was structured into five classes. After a number of "geometric parameters" were collected, the data obtained from the AIDA analysis were entered into a red, yellow, or green zone, linked to the analysis of the progress of labor. Using the AIDA analysis, we were able to identify five reference classes for patients in labor, each of which had a certain sort of birth outcome. A 100% cesarean birth prediction was made in two of these five classes. The use of artificial intelligence, through the evaluation of certain obstetric parameters in specific decision-making algorithms, allows physicians to systematically understand how the results of the algorithms can be explained. This approach can be useful in evaluating the progress of labor and predicting the labor outcome, including spontaneous, whether operative VD (vaginal delivery) should be attempted, or if ICD (intrapartum cesarean delivery) is preferable or necessary. In this investigation, we will seek, with a critical eye, to evaluate the implications of some geometric parameters measured using an intrapartum ultrasound trying to highlight all the possible complications and problems of a dystocic and eutocic labor, with an evaluation of a big volume of women in pregnancy and during labor.

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.

Being tested
AIDA Analysis
Keywords
Dystocia, Dystocic labor, Asynclitism, Intrapartum ultrasound, Labor outcomes, Delivery outcomes, Operative delivery complications
Medical subject headings
Dystocia, Wounds and Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AIDA AnalysisDevice

    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.

Study groups in NCT06664112
Study groupRoleWhat they receive
LaborThe women will be followed until and after the birth, under intrapartum ultrasound monitoring, with all clinical, ultrasonographic and obstetric parameters, analyzed by AIDA method.
Receives: Device: AIDA Analysis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Labor outcomes

    To investigate outcomes of labor, in correlation to intrapartum ultrasound monitoring analyzed by AIDA method.

    Measured: 1 year

Secondary outcomes (1)
  1. Neonatal outcomes

    The results of this study will show whether ultrasound parameters of dystocic labor assessed by AIDA method has a significant association with neonatal complications.

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Oct 2024
  2. Study start30 Sep 2024
  3. Primary completion30 Dec 2025 (estimated)
  4. Study completion30 Jun 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,000 participants (estimated)
Target duration
12 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT06664112
Sponsor's protocol ID
CER 0320
Acronym
AIDA
Status last verified
Oct 2024
First submitted
27 Oct 2024
Last updated
3 Dec 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 24553167
  • 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.

    PubMed 35817950
  • LeFevre NM, Krumm E, Cobb WJ. Labor Dystocia in Nulliparous Women. Am Fam Physician. 2021 Jan 15;103(2):90-96.

    PubMed 33448772
  • 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.

    PubMed 25283847
  • 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.

    PubMed 18696276
  • 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.

    PubMed 34217855
  • 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.

    PubMed 36553005
  • 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.

    PubMed 34216834
  • 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.

    PubMed 23865738
  • 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.

    PubMed 28743440
  • 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.

    PubMed 36427598
  • 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.

    PubMed 32882117
  • 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.

    PubMed 32570187
  • 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.

    PubMed 17826432

Questions about this trial

What is this clinical trial studying?

An observational study of Delivery Complication and Delivery Problem, run by Centro di Ricerca Clinica Salentino at 2 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 3 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Andrea Tinelli, MD (+393392074078, andreatinelli@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Labor outcomes (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06664112, which also lists 21 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2024.

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