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| Name | Class |
|---|---|
| Institut Pasteur de Dakar | OTHER |
| Fondation Sanofi Espoir | UNKNOWN |
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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.
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:
Assess women's quality of life during pregnancy and obtain satisfaction with echOpen O1 probe.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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.
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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Fatoumata D. Sarr, M.D., MPH | Institut Pasteur de Dakar | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Poste de Santé de Karang | Karang Poste | Fatick | Senegal | |||
| Centre de Santé de Sokone |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26311437 | Background | 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. | |
| 27301244 | Background | 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. |
| Label | URL |
|---|---|
| WHO recommendations on antenatal care for a positive pregnancy experience | View source |
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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.
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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.
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| Day 0 |
| Sokone |
| Fatick |
| Senegal |
| 27125579 | 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. |
| 28764602 | Background | 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. |
| 29389498 | 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. |
| 32676301 | 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. |
| 15023225 | 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. |
| 24699218 | 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. |
| 29746179 | 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. |
| 32603339 | Background | 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. |
| 29490335 | 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. |
| 29731209 | 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. |
| 31640626 | 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. |
| 28716434 | 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. |
| 1880657 | 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. |
| 23533082 | 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. |