Clinical trial NCT05765539: Performance of the Echopen Probe in Its Clinical Use for Pregnancy Follow-up in Senegal
Official title: Performance of the Echopen Probe in Its Clinical Use for Pregnancy Follow-up in Senegal
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pregnancy Related
Keywords: Medical Device
Handheld Ultrasound
Echostethoscopy
Lead sponsor: echOpen Factory
Sponsor class: INDUSTRY
Collaborators: name: Institut Pasteur de Dakar
name: Fondation Sanofi Espoir
First posted: 2023-03-13
Enrollment: 224
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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.
Primary purpose: DIAGNOSTIC

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.

Detailed 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: The intra-operator agreement
timeFrame: Day 0
Secondary outcomes:
measure: The inter-operator agreement
timeFrame: Day 0
Other outcomes:
Locations:
city: Karang
country: Senegal
facility: Poste de Santé de Karang
state: Fatick Region
city: Sokone
country: Senegal
facility: Centre de Santé de Sokone
state: Fatick Region
Study officials:
affiliation: Institut Pasteur de Dakar
name: Fatoumata D. Sarr, M.D., MPH
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
citation: 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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.