Performance of the Echopen Probe in Its Clinical Use for Pregnancy Follow-up in Senegal

Pregnancy Related Clinical Trial

— PRESTO  

Official title:

Performance of the Echopen Probe in Its Clinical Use for Pregnancy Follow-up in Senegal

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05765539
• Other study ID #: 2023-P01
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 1, 2023
• Est. completion date: January 1, 2024

Study information

• Verified date: March 2023
• Source: echOpen Factory
• Contact: Jose F. Fernandes, M.D., Ph.D.
• Phone: +33671135665
• Email: josefernandes[@]echopenfactory.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Pregnancy follow-up in a country with limited resources in decentralized areas usually consists of a clinical examination exclusively because of a lack of access to additional examination equipment and qualified personnel to use them. However, the pregnancy follow-up relies in part on the visual investigation by ultrasound scanners that estimate the risks of morbi-mortality for the mother and child during and after pregnancy. The WHO recommendations support at least one ultrasound before 24 weeks of amenorrhea. Thus, at the same time as a usual clinical examination, the possibility of visually assessing certain relevant criteria would help to increase the effectiveness of follow-up visits without complicating the care journey. A simple ultra-portable device would be an opportunity for caregivers to facilitate the detection of complications and thus offer a more adapted follow-up and orientation. This would allow, in contexts where resources are limited, to improve monitoring and limit the risks of complications due to inappropriate management.

Description:

The echOpen O1 Ultrasound Probe is a medical device designed to guide the diagnosis during clinical examination by providing a non-invasive, non-irradiant inside body image. Our hypothesis is that, with the support of a midwife trained in the use of this ultrasound stethoscopy probe, its use during pregnancy would improve the development and outcome of pregnancy for women by identifying situations requiring specificity. Through this protocol, we propose a pilot study to evaluate, under field conditions, the performance of the echOpen O1 probe as part of the 3rd-trimester pregnancy monitoring, compared to a standard ultrasound examination, routinely performed with an ultrasound machine. The main objective of this prospective pilot study is to evaluate the performance and operationality of the echOpen O1 probe from the 37th week of amenorrhea. The secondary objectives are : - To evaluate the feasibility and usability of the echOpen O1 probe in the context of pregnancy monitoring by midwives and in zone field conditions: - One urban health center (Centralized) - One rural health center (Decentralized) - Assess women's quality of life during pregnancy and obtain satisfaction with echOpen O1 probe.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 220
• Est. completion date: January 1, 2024
• Est. primary completion date: September 1, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Pregnancy = 37 weeks of amenorrhea
• Women aged = 18 years old
• Delivery scheduled to take place in the recruitment center
• Have given her written informed consent to participate

Exclusion Criteria:

• Known fetal morphological abnormality
• Emergency context during the participant's management
• Obstetrical work in progress
• Women anticipating displacement or no delivery at the clinical site

Related Conditions & MeSH terms

• Pregnancy Related

Intervention

Device:
• echOpen O1 Handheld Ultrasound device
The performance of the Handheld ultrasound device (echOpen O1 device) will be assessed during these visits for all evaluation criteria. One examination with the US machine by the midwife focused on 4 targets ; One examination with a classic US machine by the same midwife (comparator) including the search for the four targets ; One examination with the US machine by a second operator ; Review of the images obtained by the US machine by the referring radiologist at a separate point of time. The mode of delivery and the vital status of the mother and newborn will also be collected. Operator A will start by using either the echOpen O1 device or the US machine (random order, via sealed envelopes) and will then perform the other type of examination. Another operator (Operator B) will come to perform an examination with the Handheld ultrasound device (blind to the result of the first operator). The switch between operators A and B will also be random.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
echOpen Factory	Fondation Sanofi Espoir, Institut Pasteur de Dakar

References & Publications (16)

Ahman A, Edvardsson K, Lesio Kidanto H, Ngarina M, Small R, Mogren I. 'Without ultrasound you can't reach the best decision' - Midwives' experiences and views of the role of ultrasound in maternity care in Dar Es Salaam, Tanzania. Sex Reprod Healthc. 2018 Mar;15:28-34. doi: 10.1016/j.srhc.2017.11.007. Epub 2017 Nov 22. — View Citation

Amoah B, Anto EA, Osei PK, Pieterson K, Crimi A. Boosting antenatal care attendance and number of hospital deliveries among pregnant women in rural communities: a community initiative in Ghana based on mobile phones applications and portable ultrasound scans. BMC Pregnancy Childbirth. 2016 Jun 14;16(1):141. doi: 10.1186/s12884-016-0888-x. — View Citation

Ballard JL, Khoury JC, Wedig K, Wang L, Eilers-Walsman BL, Lipp R. New Ballard Score, expanded to include extremely premature infants. J Pediatr. 1991 Sep;119(3):417-23. doi: 10.1016/s0022-3476(05)82056-6. — View Citation

Edvardsson K, Mogren I, Lalos A, Persson M, Small R. A routine tool with far-reaching influence: Australian midwives' views on the use of ultrasound during pregnancy. BMC Pregnancy Childbirth. 2015 Aug 27;15:195. doi: 10.1186/s12884-015-0632-y. — View Citation

Edvardsson K, Ntaganira J, Ahman A, Sengoma JP, Small R, Mogren I. Physicians' experiences and views on the role of obstetric ultrasound in rural and urban Rwanda: a qualitative study. Trop Med Int Health. 2016 Jul;21(7):895-906. doi: 10.1111/tmi.12718. Epub 2016 May 18. — View Citation

Glazebrook R, Manahan D, Chater B, Barker P, Row D, Steele B, Morris G, Cornelius S, McLellan T. Educational needs of rural and remote Australian non-specialist medical practitioners for obstetric ultrasound. Aust J Rural Health. 2004 Apr;12(2):73-80. doi: 10.1111/j.1038-5282.2004.00559.x. — View Citation

Gomes DJ, Kaufman B, Aluisio AR, Kendall S, Thomas V, Bloem C. Assessment of Acute Obstetrical Needs and the Potential Utility of Point-Of-Care Ultrasound in the North East Region of Haiti: A Cross-Sectional Study. Ann Glob Health. 2020 Jul 3;86(1):72. doi: 10.5334/aogh.2597. — View Citation

Holmlund S, Ntaganira J, Edvardsson K, Lan PT, Semasaka Sengoma JP, Ahman A, Small R, Mogren I. Improved maternity care if midwives learn to perform ultrasound: a qualitative study of Rwandan midwives' experiences and views of obstetric ultrasound. Glob Health Action. 2017;10(1):1350451. doi: 10.1080/16549716.2017.1350451. — View Citation

Kang C, Qaqish B, Monaco J, Sheridan SL, Cai J. Kappa statistic for clustered dichotomous responses from physicians and patients. Stat Med. 2013 Sep 20;32(21):3700-19. doi: 10.1002/sim.5796. Epub 2013 Mar 27. — View Citation

Narula J, Chandrashekhar Y, Braunwald E. Time to Add a Fifth Pillar to Bedside Physical Examination: Inspection, Palpation, Percussion, Auscultation, and Insonation. JAMA Cardiol. 2018 Apr 1;3(4):346-350. doi: 10.1001/jamacardio.2018.0001. — View Citation

Shah S, Santos N, Kisa R, Mike Maxwell O, Mulowooza J, Walker D, Muruganandan KM. Efficacy of an ultrasound training program for nurse midwives to assess high-risk conditions at labor triage in rural Uganda. PLoS One. 2020 Jun 30;15(6):e0235269. doi: 10.1371/journal.pone.0235269. eCollection 2020. — View Citation

Slavin V, Gamble J, Creedy DK, Fenwick J, Pallant J. Measuring physical and mental health during pregnancy and postpartum in an Australian childbearing population - validation of the PROMIS Global Short Form. BMC Pregnancy Childbirth. 2019 Oct 22;19(1):370. doi: 10.1186/s12884-019-2546-6. — View Citation

Swanson JO, Kawooya MG, Swanson DL, Hippe DS, Dungu-Matovu P, Nathan R. The diagnostic impact of limited, screening obstetric ultrasound when performed by midwives in rural Uganda. J Perinatol. 2014 Jul;34(7):508-12. doi: 10.1038/jp.2014.54. Epub 2014 Apr 3. — View Citation

Van den Hof MC. No 359-Effets biologiques et innocuite de l'echographie obstetricale. J Obstet Gynaecol Can. 2018 May;40(5):633-639. doi: 10.1016/j.jogc.2018.04.008. No abstract available. Erratum In: J Obstet Gynaecol Can. 2018 Dec;40(12):1703. — View Citation

Vinayak S, Brownie S. Collaborative task-sharing to enhance the Point-Of-Care Ultrasound (POCUS) access among expectant women in Kenya: The role of midwife sonographers. J Interprof Care. 2018 Sep;32(5):641-644. doi: 10.1080/13561820.2018.1470499. Epub 2018 May 10. — View Citation

Vinayak S, Sande J, Nisenbaum H, Nolsoe CP. Training Midwives to Perform Basic Obstetric Point-of-Care Ultrasound in Rural Areas Using a Tablet Platform and Mobile Phone Transmission Technology-A WFUMB COE Project. Ultrasound Med Biol. 2017 Oct;43(10):2125-2132. doi: 10.1016/j.ultrasmedbio.2017.05.024. Epub 2017 Jul 14. — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The intra-operator agreement	The intra-operator agreement will be measured on the result of the 4 ultrasound targets chosen. The 4 ultrasound targets for each pregnancy are: The fetal position; Number of fetuses; Fetal vitality (presence of fetal heartbeat) Placental implantation To define an intra-operator concordance, the images for the 4 ultrasound targets (collected by the same operator) must be identical for both devices (echOpen probe and Ultrasound device routinely used in pregnant women)	Day 0
Secondary	The inter-operator agreement	The inter-operator concordance will be measured on the result of the 4 ultrasound targets chosen. The 4 ultrasound targets for each pregnancy are: The fetal position; Number of fetuses; Fetal vitality (presence of fetal heartbeat) Placental implantation To define an inter-operator concordance, the images on the 4 ultrasound targets (collected by two different operators) must be identical for the same device (echOpen probe).; All ultrasound images will go to the radiologist for review and validation. This review will be done blindly of the result provided by the operators.	Day 0

External Links

•   WHO recommendations on antenatal care for a positive pregnancy experience