News Letter of Kagawa Association of Obstetricians and Gynecologists No.38 2023-4

The use in developing countries is reimported to Japan
Mobile Fetal Monitor (iCTG) from Kagawa Prefecture recognized by WHO～From use at individual medical institutions to networking of medical institutions in the entire region～
Prof. HARA Kazuhiro, MD, Ph.D.
Emeritus Professor, Kagawa University
Visiting
scholar, Department of Medical
Informatics, Faculty of Medicine,
Kagawa University
Honorary President,
Japanese Telemedicine and Telecare Association

Introduction

throughout Japan. It is very important to promote

The United Nations has adopted thethe use of fetal monitoring in developing countries.

Sustainable Development Goals (SDGs), and 17

This paper describes the development ofgoals are to be achieved by 2030. SDG 3.1 is toan ultra-compact mobile fetal monitor (iCTG),

reduce the global maternal mortality rate to lesswhich is currently being introduced in Thailand,

than 70 per 100,000. SDG 3.2 is to reduce the

Myanmar, Bhutan, and other developing countries

neonatal mortality rate in all countries to 12 andwith the support of the Ministry of Internal Affairs

less per 1,000. In addition, United Nations

and Communications, JICA, and United Nations

Children's Fund, UNICEF, reports that 2 million

Development Program, UNDP.

unborn babies, one every 16 seconds, die before
delivery each year in developing countries aroundthe world. It is urgent assignment to reducematernal, perinatal, and fetal deaths by improving
pregnancy management.

1. Basic Structure of Fetal Monitors and the Early
Development of Mobile Fetal Monitors
Development of Fetal Monitors
Almost 50 years have already passed since

As for other SDGs (e.g., carbon dioxide

the development and widespread use of fetal

emissions), developed countries themselves havemonitors. The central monitor is a device thatnot yet achieved these goals, and both developed

continuously

and developing countries need to make efforts toheartbeats and uterine contractions of multiple

achieve them. On the other hand, Japan has alreadypregnant women (hereinafter referred to as "fetal

achieved the target value of SDGs 3 to a large

heartbeat information") to nurse stations in theextent. The world expects Japan to promote its

hospital. However, the basic performance of theexcellent perinatal health care approach globally.

system is limited to the extent that it can be

The significant decrease in the perinatal mortality

continuously monitored at a station. The fetal

rate in Japan is due to progress in perinatal

monitor using ultrasound consists of followings; amanagement of preterm and low birth weighthigh-frequency

infants, but also because of fetal monitoring fromelement that converts high-frequency wave into

pregnancy to delivery at obstetric institutions

ultrasonic wave, a ceramic element that converts

providesinformation

oscillation

circuit,

on

a

fetal

ceramic

News Letter of Kagawa Association of Obstetricians and Gynecologists No.38 2023-4
reflected ultrasonic wave into high-frequency

mobile devices such as tablets and smartphones has

signal, a detection circuit that extracts thesince then led to the development of mobile fetal

necessary information from the weak electricalmonitors. The mobile fetal monitor is also expectedsignal, and the circuit that detects the heart rate

to be smaller than ever. We developed an ultra-

from the resulting ultrasonic Doppler signal that iscompact fetal monitor (hereafter, iCTG) based on

the most difficult part and that is to calculate theheart rate using the autocorrelation method, and arecording equipment that records the obtained
heart rate on recording sheets of paper. With the

a completely new concept, without being bound by
conventional technologies.
The concepts are listed below, and themost technically challenging part was to integrate

advancement of semiconductors, it is relatively easyanalog and digital electronic circuits into the iCTG,

to miniaturize electronic circuits. However, evenand fit them into a transducer case.

with the widespread use of electronic medical(1) Mobile and cloud-based so that fetal heart rate

records, for some reason, long sheets of paper are

can be sent from anywhere in the world.

still often used, preventing the miniaturization ofdevices.
More than 20 years ago, we developed aportable fetal monitor, approximately 2 kg, that

(2) Fetal heart rate and uterine contractions will berecorded on a cloud server at the data center.
(3) Eliminate recording paper and realize acompletely paperless system.

eliminates the need for a recording device by(4) The electronic circuitry of the basic part of thedisplaying the fetal heart rate on an LCD screen.

fetal monitor will be miniaturized, and fitted into

Initially, the information was sent over a telephonetheline (using an acoustic coupler). As digitaltransducers.

communication emerges, and after the age of
personalcomputercommunication

and

the

Internet, mobile networks were also used to send
information. This is known as mobile CTG. Thisultrasoundtransducers

and

labor

pain

(5) The fetal heart rate and uterine contractions are
displayed and connected to the Internet using acommercially available tablet.
(6) The ultrasound transducer and the tablet are

early stage mobile CTG was used by the loyal family,

connected by a Bluetooth connection.

and in Tono City, Iwate Prefecture, Amami(7) A lithium-ion battery is used as the power

Oshima Island in Japan, and Chiang Mai, Thailand,source and the device will be cordless. (This will

and it received a very high evaluation.

make it easier to use in developing countries whereIn

introducing

fetal

monitorstodeveloping countries, we need to develop an ultracompact mobile fetal monitor using the latest
technology, and a network system to be usedthroughout the region.
2. Concept of developing an ultra-compact
mobile fetal monitor (iCTG) using the latest
technology
The rapid miniaturization and diffusion of

the power supply is unstable.)
3. TheiCTG

weighsabout

1/50thofaconventional fetal monitor, but the heart rate
detection accuracy is equal to or better than theconventional fetal monitor.
The iCTG consists of an ultrasoundtransducer to detect fetal heart rate, a labor paintransducer, and a tablet. The information transfer
between the transducers and the tablet isNews Letter of Kagawa Association of Obstetricians and Gynecologists No.38 2023-4
connected via Bluetooth. The information sent toautocorrelation has been further improved in terms

the tablet is transmitted over Wi-Fi, 3G or 4Gof the accuracy of fetal heart rate detection.

(LTE) mobile networks to a cloud server on the

The performance is equal to or better than that ofInternet and can be monitored in real time from theconventional fetal monitors. The fetal monitors of

medical institutions. The fetal heart rate is

the 1970s weighed more than 15 kg (including thetransmitted and stored in a format based on thecart), whereas the iCTG weighs about 300 g

Japan Society of Obstetricians and Gynecologists(including both transducers), which is almost(JSMG) fetal heart rate information file data format

1/50th of the original weight (Fig. 1).

described

below.

The

logic

circuitofthe(Fig1) Fetal monitor weighed over 15 kg in 1970, whereas iCTG weighs about 300g, downsized to 1/50.
4. The need for a standardized method of

as a voltage signal (e.g., 1 V for 100 heartbeats, 2 Vtransmitting and storing fetal heart rate and thefor 200 heartbeats, etc.). However, with voltage

Establishmentofsignals, the voltage drops over long distances, andObstetricians and Gynecologists (JSMG) Fetal

AC noise from the outside tends to enter the signal.

Heart.

Therefore, nowadays, digital signals are used.

ofJapanese

Society

Fetal Heart Rate Information File Data Format

However, even for digital signals, there are many

The following is an explanation of thesystems in which digital signals are simply sent

method of transmitting and storing fetal heart ratecontinuously. The signal itself does not containusing a central monitor as an example. The signal

information such as whose signals they are, what

is sent from the output terminal of the fetal monitor

day, what time, what minute, what second, etc.

News Letter of Kagawa Association of Obstetricians and Gynecologists No.38 2023-4
The data is recorded on the server withup company to obtain certification from theinformation such as whose signals they are, datenational government to manufacture and sell

and time, but the digital method and storage

medical devices. We are truly grateful for all themethod differ from company to company. In

support we have received.

addition, recently, information obtained from fetal

6. The introduction of mobile medical devices indeveloping countries is medically and sociallymonitors at multiple medical institutions is being

significant

collected at one location, and those servers arelocated within the medical institutions. Essentially,
it is desirable to store the patient's name in the fetal

Initially, considerable difficulties were
anticipated in introducing mobile medical devices

monitor, weeks of gestation, date and time, etc., intoa standardized format on cloud servers via Internet.

introduction went very smoothly. In developed

A universal system can be realized by doing so.
The Committee on Information Systemsof the Japanese Society of Obstetricians anddeveloping

countries,

but

in

fact

the

countries, wired telecommunications were first
installed nationwide over a long period of time,
followed by ISDN, ADSL, and then optical fiber

Gynecologists (at that time) already proposed thecable. Then, optical cables were introduced, andstandardization of fetal heart rate digitization in

the speed of communication rapidly increased. The

1998. The proposal was approved by the Japanese

shift to mobile communications has also progressed

Society of Obstetrics and Gynecology and therapidly, from i-mode to 3G, 4G (LTE), andJapanese Society of Medical Informatics. When

recently to 5G (LTE), and use of smart phone iscreating standardization plan, companies like Toitu,

flourishing with use of 5G. In developing countries,

Atom

on the other hand, where households had few wired

MedicalCorporation,

andYokogawa

Hewlett-Packard (YHP), which were selling fetal

telephones, the mobile environment was quickly

monitors at the time, also approved the proposal fordeveloped, and smartphones have exploded into

standardization.

widespread use. Mobile calls and e-mails are of(https://www.jstage.jst.go.jp/article/jami/20/2/2
0_143/_pdf/-char/en)

course useful, but the most valuable use of mobile
phones is in the field of medical care. In addition,social significance is also high, as the effective use

5. Establishment of Melody International, auniversity ventureof mobile infrastructure with a huge budget willlead to a higher level of medical care. In this sense,

The development of a medical device

it is fortunate that governments in developing

based on a completely new concept such as this, iscountries, especially ministries of health andvery risky and it is difficult for existing companies

obstetricians, have shown interest in mobile fetal

to take on the challenge. Therefore, a new venture

monitoring.

company,

MelodyInternational

Inc.

was

established. The development of the ultra-compact

7. The excellent results of the use of iCTG in

mobile fetal monitor was carried out from design todeveloping countries have led to its recognitioncommercialization in Kagawa Prefecture, which

as a WHO recommended medical device.

has the best perinatal mortality rate in Japan and

The purpose of the development of thethe world. The main goal of the project is tomobile fetal monitor in Japan was to target

promote the "Made in Kagawa" brand to the world.

pregnant women living in remote areas and high-It is said that it is extremely difficult for a local start-risk pregnant women. In addition, obstetric care

News Letter of Kagawa Association of Obstetricians and Gynecologists No.38 2023-4
providers throughout Japan were already using the

program will be started with only a few clinics.

mobile fetal monitoring system.

However, if the usefulness of iCTG is recognized,

The conventional hospital-based fetal monitors are

the system will be expanded to cover all clinics inalready well established in obstetric care facilities

the region. In fact, a JICA project in Chiang Mai,

throughout Japan, so it was necessary to separate

Thailand started with a university hospital andtheir use.

three maternity hospitals in remote areas andIn developing countries, except for core

expanded to 25 medical institutions in the whole

hospitals, there are basically no fetal monitors in

Chiang Mai province. The project has produced

obstetric care facilities nationwide. As in the case of

excellent results.

smartphones, which quickly spread without the era

Coincidentally, at the same time, theof fixed-line phones, there is no need to separate

Queen of Bhutan was pregnant with her second

the two, and it is possible that all fetal monitors willchild and used iCTG. She liked it very much andbe mobile. In distributing iCTG, it is often the casestrongly hoped that it would be used by women allthat physicians in urban core hospitals are the firstover the country. The government of Bhutan was

to show interest and use it. However, priority

therefore introduced 55 sets of iCTGs in 46

should be given from the outset to clinics that

hospitals in Bhutan with support of United Nations

handle pregnancies in rural areas. The diagnosis ofDevelopment Program, UNDP and JICA, and thefetal heart rate patterns should be performed byresults were better than expected. Therefore, thephysicians at core hospitals who are experienced in

iCTG system has been installed in JICA-supported

the use of fetal monitors, taking advantage of the

project to additionally install 25 new sets of iCTGs

features of iCTG that can be used remotely. This

(80 sets in total) in Bhutan. The project iswill realize an efficient division of labor between
core hospitals and local medical institutions.
Initially, due to budgetary constraints, the(Fig 2)scheduled to run for three years to cover Bhutan
nationwide (Fig.2)

News Letter of Kagawa Association of Obstetricians and Gynecologists No.38 2023-4
With support of UNDP and JICA, 55 sets of iCTG

In Japan, we stated that a distinction

were introduced to Bhutan. Results were betterneeds to be made between the use of conventional

than expected, and 25 more sets, a total of 80 sets

fetal monitoring and iCTG. However, the situation

were additionally introduced as JICA direct support

has changed drastically with the recent COVID-19

project this year. Based on these achievements,

disaster, with the deregulation of online medical

iCTG has been recognized by the WHO as a new
innovative medical technology and a recommended

New

Usage

Patterns

control increased nationwide.
Initially, iCTG was administered todevice. We consider that was a great honor.
8. Reimporting

care and introduction of iCTG for pregnancy

pregnant women to prevent infection during theirin

Developing Countries Back to Japan

outpatient visits, and to reduce hospital visits bysending the baby's heartrate from home to the

In developing countries, the mobile

medical institution. In the case of pregnant womencharacteristics of iCTG can be used to network

who were already infected (including those closely

between core hospitals and local obstetric care

contacted women), pregnant women in infectious

facilities. In other words, it is a method todisease ward, hotels and other accommodationsorganically manage pregnancies in the entire

were remotely managed by medical institutions.

region as a whole by connecting the core hospitalOnce online medical care becomes widespread, it isand local obstetric institutions through a network.

expected to become increasingly popular even after(i.e., the management of the entire region as a

the end of the corona outbreak. The same isplane, rather than connecting local medical

expected to be true for the remote management ofinstitutions

pregnant women, not only in remote areas but alsoonapoint-to-point

basis).

In

developing countries, transportation of patients isin urban areas.

also frequent, so use of iCTG on the vehicles is also

iCTGs will be widespread throughout the country

very important. The followings were found about

by then, facilitating the realization of a region-wide

the use of iCTG in developing countries. The use

perinatal network.

of iCTG throughout a region can accurately
diagnose the condition of the fetus, andcases transporting pregnant women to higher-level
medical facilities before the condition of the fetus
worsens increased. In addition, when transporting
pregnant women, the condition of the fetus duringtransport is known, allowing the receiving medical
institution to respond with more time to spare. As
a result, the number of newborns in poor condition
has decreased, which in turn has led to a decrease

Conclusion
The history of the development of themobilefetal

monitor(iCTG),

its

overseas

deployment, and the standardization of the numberof fetal heartbeats were reported. Pregnancy
management methods for the entire region, whichshould have been realized in developed countries,
are being realized first in developing countries.
This means that the next step would be to reimportburden on neonatologists.

them. Japan should also introduce it as soon as

9. Easing of Deregulations of online medical

importation. Kagawa Prefecture has the best

possible, although it will be a form of back-services and Rapid Introduction of iCTG underperinatal results in the world, and since iCTG is a

COVID-19

system developed in Kagawa Prefecture, so weNews Letter of Kagawa Association of Obstetricians and Gynecologists No.38 2023-4
hope that a network integrating all obstetricinstitutions in Kagawa Prefecture will be realized.
(We sincerely appreciate the support of UNDP,
JICA, and the Ministry of Internal Affairs andCommunications. )