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

NCT05765539 | Completed

• 1 other identifier: 2023-P01
• Study Type: interventional
• Target: 224
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Pregnancy Related

Keywords

Medical Device; Handheld Ultrasound; Echostethoscopy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• The inter-operator agreement

  Day 0

Study Arms (1)

Pregnant women benefitting ultrasound examination

EXPERIMENTAL

This is the unique arm of the study. This arm is made of eligible pregnant women, with a pregnancy of at least 37 weeks.

Device: echOpen O1 Handheld Ultrasound device

Interventions

echOpen O1 Handheld Ultrasound device 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.

Also known as: Multicentric prospective comparative study

Pregnant women benefitting ultrasound examination

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• echOpen Factory: lead
• Institut Pasteur de Dakar: collaborator
• Fondation Sanofi Espoir: collaborator

Study Sites (2)

Poste de Santé de Karang

Karang, Fatick, Senegal

Location

Centre de Santé de Sokone

Sokone, Fatick, Senegal

Location

Related Publications (16)

• Hill CJ, Rowe SI, Lovrien EW. Probable genetic linkage between human serum amylase (Amy 2 ) and Duffy blood group. Nature. 1972 Jan 21;235(5334):162-3. doi: 10.1038/235162a0. No abstract available.

  PMID: 4551225 BACKGROUND

• Rundcrantz H. Posture and Eustachian tube function. Acta Otolaryngol. 1969 Oct;68(4):279-92. doi: 10.3109/00016486909121567. No abstract available.

  PMID: 4906986 BACKGROUND

• 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.

  PMID: 27125579 BACKGROUND

• Tolins SH, Cooper P. Presacral teratoma. Am J Surg. 1968 May;115(5):734-7. doi: 10.1016/0002-9610(68)90114-1. No abstract available.

  PMID: 5645676 BACKGROUND

• 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.

  PMID: 29389498 BACKGROUND

• 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.

  PMID: 32676301 BACKGROUND

• 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.

  PMID: 15023225 BACKGROUND

• 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.

  PMID: 24699218 BACKGROUND

• 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.

  PMID: 29746179 BACKGROUND

• 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.

  PMID: 7326214 BACKGROUND

• 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.

  PMID: 29490335 BACKGROUND

• 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.

  PMID: 29731209 BACKGROUND

• 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.

  PMID: 31640626 BACKGROUND

• 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.

  PMID: 28716434 BACKGROUND

• 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.

  PMID: 1880657 BACKGROUND

• 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.

  PMID: 23533082 BACKGROUND

Related Links

• WHO recommendations on antenatal care for a positive pregnancy experience

Study Officials

• Fatoumata D. Sarr, M.D., MPH

  Institut Pasteur de Dakar

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Midwife 'A' will begin by using either the echOpen probe or the classic US machine (in a random order, via sealed envelopes), and will then carry out the other type of examination. The results book will be filled in and validated after each examination, and it will not be possible to modify the results after the 2nd examination has been carried out. Another midwife (midwife 'B') will examine with the echOpen probe (blind to the first midwife's result). The alternation between midwife 'A' and midwife 'B' will also be random.
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A single group, comparative, non-randomized, controlled study. Each patient represents her/his own control: the patient is examined consecutively with the echOpen probe, then with the probe used in the department.

Study Record Dates

• First Submitted: March 1, 2023
• First Posted: March 13, 2023
• Study Start: November 29, 2023
• Primary Completion: August 30, 2024
• Study Completion: June 19, 2025
• Last Updated: September 19, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

SE (2)