Delivery Outcomes by AIDA (Artificial Intelligence Dystocia Algorithm) Analysis

NCT06664112 | Recruiting

• 1 other identifier: CER 0320
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 2

Brief 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). 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.

Conditions

Delivery Complication; Delivery Problem; Delivery; Injury; Delivery; Injury, Maternal; Delivery;Breech;Stillbirth; Delivery Problem for Fetus

Keywords

Dystocia; Dystocic labor; Asynclitism; Intrapartum ultrasound; Labor outcomes; Delivery outcomes; Operative delivery complications

Outcome Measures

Primary Outcomes (1)

• Labor outcomes

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

  1 year

Secondary Outcomes (1)

• Neonatal outcomes

  1 year

Other Outcomes (3)

• Fetal outcomes

  1 year

• Perinatal outcomes

  1 year

• NICU (Neonatal Intensive Care Unit) admittance outcomes

  1 year

Study Arms (1)

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.

Device: AIDA Analysis

Interventions

AIDA Analysis DEVICE

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.

Labor

Eligibility Criteria

• Age: 20 Years - 45 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• Patients who are candidates for cesarean section.
• Patients in premature labor.
• Patients who do not agree to participate in the study.
• Missing data relevant for the study.

Sponsors & Collaborators

• Centro di Ricerca Clinica Salentino: lead

Study Sites (2)

Ospedale Veris delli Ponti

Scorrano, Lecce, 73020, Italy

RECRUITING

Andrea Tinelli

Lecce, Le, 73100, Italy

RECRUITING

Related Publications (21)

• 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.

  PMID: 24553167 RESULT

• 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.

  PMID: 35817950 RESULT

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

  PMID: 33448772 RESULT

• Akmal S, Paterson-Brown S. Malpositions and malpresentations of the foetal head. Obstet Gynaecol Reprod Med. 2009 Sep 1;19(9):240-6.

  RESULT

• 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.

  PMID: 25283847 RESULT

• 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.

  PMID: 18696276 RESULT

• 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.

  PMID: 34217855 RESULT

• 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.

  PMID: 36553005 RESULT

• 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.

  PMID: 34216834 RESULT

• 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.

  PMID: 23865738 RESULT

• 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.

  PMID: 28743440 RESULT

• 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.

  PMID: 36427598 RESULT

• 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.

  PMID: 32882117 RESULT

• 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.

  PMID: 32570187 RESULT

• 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.

  PMID: 17826432 RESULT

• 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.

  PMID: 23288706 RESULT

• 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.

  PMID: 29974596 RESULT

• 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.

  PMID: 35618672 RESULT

• 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.

  PMID: 34384775 RESULT

• 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.

  PMID: 38786561 RESULT

• 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.

  PMID: 39194983 RESULT

Related Links

• 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.

MeSH Terms

Conditions

Dystocia; Wounds and Injuries

Condition Hierarchy (Ancestors)

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

Study Officials

• Andrea Tinelli, MD

  Veris delli Ponti Hospital Scorrano, 73020 Lecce, Italy

  STUDY DIRECTOR

Central Study Contacts

Andrea Tinelli, MD

CONTACT

+393392074078; andreatinelli@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2024
• First Posted: October 29, 2024
• Study Start: September 30, 2024
• Primary Completion: December 30, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: December 3, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

IT (2)