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Background: Over 3 million stillbirths occur annually in sub Saharan Africa; most occur intrapartum and are largely preventable. The standard of care for fetal heart rate (FHR) assessment in most sub-Saharan African settings is a Pinard Stethoscope, limiting observation to one person, at one point in time. We aimed to test the functionality and acceptability of a wireless FHR monitor that could allow for expanded monitoring capacity in rural Southwestern Uganda. Methods: In a mixed method prospective study, we enrolled 1) non-laboring healthy term pregnant women to wear the device for 30 min and 2) non-study clinicians to observe its use. The battery-powered prototype uses Doppler technology to measure fetal cardiotocographs (CTG), which are displayed via an android device and wirelessly transmit to cloud storage where they are accessible via a password protected website. Prototype functionality was assessed by the ability to obtain and transmit a 30-min CTG. Three obstetricians independently rated CTGs for readability and agreement between raters was calculated. All participants completed interviews on acceptability. Results: Fifty pregnant women and 7 clinicians were enrolled. 46 (92.0%) CTGs were successfully recorded and stored. Mean scores for readability were 4.71, 4.71 and 4.83 (out of 5) with high agreement (intra class correlation 0.84; 95% CI 0.74 to 0.91). All pregnant women reported liking or really liking the device, as well as high levels of comfort, flexibility and usefulness of the prototype; all would recommend it to others. Clinicians described the prototype as portable, flexible, easy-to-use and a time saver. Adequate education for clinicians and women also seemed to improve correct usage and minimise concerns on safety of the device. Conclusions: This prototype wireless FHR monitor functioned well in a low-resource setting and was found to be acceptable and useful to both pregnant women and clinicians. The device also seemed to have potential to improve the experience of the users compared with standard of care and expand monitoring capacity in settings where bulky, wired or traditional equipment are unreliable. Further research needs to investigate the potential impact and cost of such innovations to improve perinatal outcomes.
We conducted a cross-sectional observational study involving quantitative and qualitative methods of data collection at Mbarara Regional Referral Hospital, a publically-funded teaching hospital in rural south-western Uganda. We used a mixed methods study involving documentation of device functionality, as well as surveys to quantify acceptability and qualitative interviews to provide a more in depth understanding of factors related to acceptability [17]. The hospital employs 11 obstetricians and 22 midwives and performs over 10,000 deliveries annually [18] with approximately twenty beds located in each of two wings on the ward. Maternity departmental records of 2015 also indicate a maternal mortality rate of 270/100,000 live birth, caesarean section rate of 30% and a perinatal mortality rate of 56/1000. Although often incompletely implemented, all mothers in labour are ideally monitored using a partogram- a graph of labour parameters and cervical dilation over time with pre-printed alert and action lines designed to prompt intervention if a woman’s curve deviates from the expected course. The fetal heart rate is monitored manually per clinician judgment using the Pinard (Fig. (Fig.1).1). No electronic monitors are used on this ward, except for an ultrasound scan that is occasionally used to confirm presence or absence of regular cardiac pulsations, but not for monitoring labour. No wireless internet connection is available in the ward although cellular phone network coverage is available from multiple cellular phone companies. The ward walls are made of concrete (potential for interfering with wireless data transmission) This study involved two types of participants: pregnant women and clinical staff observing the wireless fetal monitoring prototype. Using a convenience sample, we screened and recruited healthy non-laboring pregnant women, aged 18 and older, carrying a singleton gestation estimated to be at term and admitted to MRRH. The women were asked to wear the prototype for thirty minutes. Women who were unwilling to wear the monitoring device or those with a known infectious disease or hypersensitivity to materials found in the device were excluded. We also recruited a convenience sample of clinical staff to interact with the device and observe its use on recruited pregnant women. Informed written consent was obtained for all participants prior to enrolment. The study was conducted between May 2014 and August 2014. The use of this wireless fetal monitor prototype has been previously described [15, 19] This device was developed by Gary and Mary West Health Institute, San Diego, California (Fig. (Fig.2).2). The device has received FDA approval for healthcare providers to use it to monitor expectant mothers and their fetuses during the antepartum period. FDA approval for use during active labor has not been approved. In our study we limited eligibility to non-laboring pregnant women. This non-invasive prototype technology uses Doppler-based technology to assess and record fetal heart rate combined with pressure sensors to track uterine contractions. Data is then transmitted via Bluetooth technology to a gateway device (either smartphone or tablet) where the cardiotocogragh is displayed and visualized in real time. In our study, we used the Samsung Galaxy Note (GT-N7000) as the gateway device. Once monitoring is complete, data is then transmitted from the gateway device to a secure web-based server for storage or further viewing through a web portal. Four steps are required to completely upload monitoring data on to the server; 1) save button, 2) a prompt to confirm completion of fetal heart rate recording session, 3) submit button to enable submission of data, 4) confirmation of data uploading on to the server for review via password access of any device that can access the web. Noteworthy, this study partly involves three of the authors in the Boatin study [15]. The wireless fetal heart monitoring prototype in use at Mbarara Regional Referral Hospital All study procedures were performed by trained research midwives and resident obstetricians. At enrollment, study staff collected basic socio-demographic data and a brief obstetrical history from enrolled pregnant women using questionnaires and the medical record. The profession of the clinical staff (e.g. physician, resident, nurse, and midwife) was also noted. Pregnant women were then asked to wear the prototype for 30 min. Study staff noted any technical challenges in obtaining and transmitting the fetal cardiotocographs. Following the monitoring session, a study obstetrician reviewed the cardiotocograph, prior to participant’s discharge from the study for safety, as well as quality. Clinical management decisions were made as per standard of care and no intervention was made on the basis of this technology prototype output. If there were concerns noted, they were confirmed by traditional methods (Pinard) used on the ward. The pregnant woman and clinical staff interacting with the device in use were asked to complete a brief questionnaire. Data from all questionnaires was transferred to a secure electronic database. The prototype tracings were not saved as part of the pregnant woman’s medical record. For this study, all women wore a pulse oximeter to allow differentiation from the fetal heart rate. Stratifying by age of the pregnant women (greater than or less than 30 years of age) to obtain a balance in participants, we identified five of the pregnant women participants for a qualitative interview. We used a convenience sample to identify seven of the clinical staff for qualitative interviews. These interviews further explored the perceptions, use, likes, dislikes, design and possible recommendations of this device, as guided by the technology acceptance model Fig. Fig.33 [20]. This interview took place immediately after monitoring, lasted approximately 30 min in a private space, and was digitally recorded for transcription. Technology acceptance model as applied to a wireless prototype cardiotocography technology in rural Uganda. The qualitative interviews of both pregnant women and clinician participants informed the model; actual use will be explored in future studies Our study was designed as a pilot to test functionality and feasibility. The number of participants was based on a convenience sample in which pregnant woman and clinicians were enrolled until sufficient data were obtained to assess the study goals and additional enrolment and data did not change study findings and interpretation. Quantitative data on participant characteristics, prototype acceptability and use were summarized and explored descriptively. Functionality was defined as the ability of the device to record a 30-min foetal cardiotocograph, upload this data to the cloud-based server, and retrieve and review the cardiotocograph. Three obstetricians rated the cardiotocographs for tracing quality and interpretability. Tracings were given a score from 1 to 5 (1 = difficult to read, 5 = easy to read) and the interclass correlation was calculated to assess agreement between raters. Transcripts were derived from the qualitative interviews. Common cross-cutting categories were then generated from these transcripts and presented in line with the technology acceptance model.
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