Performance of the Echopen Probe in Its Clinical Use for Pregnancy Follow-up in Senegal
NCT ID: NCT05765539
Last Updated: 2025-09-19
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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COMPLETED
NA
224 participants
INTERVENTIONAL
2023-11-29
2025-06-19
Brief Summary
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This would allow, in contexts where resources are limited, to improve monitoring and limit the risks of complications due to inappropriate management.
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Detailed Description
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The investigator's hypothesis is that the use of this ultrasound stethoscopy probe during pregnancy, by a trained midwife, would improve the development and outcome of pregnancy for women by identifying situations requiring specificity. Through this protocol, the investigators 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.
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Pregnant women benefitting ultrasound examination
This is the unique arm of the study. This arm is made of eligible pregnant women, with a pregnancy of at least 37 weeks.
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Women aged ≥ 18 years old
* Delivery scheduled to take place in the recruitment center
* Have given her written informed consent to participate
Exclusion Criteria
* Emergency context during the participant's management
* Obstetrical work in progress
* Women anticipating displacement or no delivery at the clinical site
18 Years
FEMALE
No
Sponsors
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Institut Pasteur de Dakar
OTHER
Fondation Sanofi Espoir
UNKNOWN
echOpen Factory
INDUSTRY
Responsible Party
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Principal Investigators
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Fatoumata D. Sarr, M.D., MPH
Role: PRINCIPAL_INVESTIGATOR
Institut Pasteur de Dakar
Locations
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Poste de Santé de Karang
Karang, Fatick, Senegal
Centre de Santé de Sokone
Sokone, Fatick, Senegal
Countries
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References
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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.
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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.
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.
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.
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.
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.
Pound AW, Walker NI. Involution of the pancreas after ligation of the pancreatic ducts. I: a histological study. Br J Exp Pathol. 1981 Dec;62(6):547-58.
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.
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.
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.
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.
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.
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.
Related Links
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WHO recommendations on antenatal care for a positive pregnancy experience
Other Identifiers
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2023-P01
Identifier Type: -
Identifier Source: org_study_id
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