臨床研究等提出・公開システム

Date of registration	Feb. 08, 2024
Last modified on	Jan. 10, 2025
Trial ID	jRCT1062230101

Scientific Title	The usefulness of color Doppler in fetal echocardiography screening
Public Title	The usefulness of color Doppler in fetal echocardiography screening

Completion date	Mar. 31, 2023
Result actual enrolment	94
Baseline Characteristics	Congenital heart disease that was screened by fetal echocardiography during pregnancy at our hospital from January 2013 to March 2023.
Participant flow	We examined 94 cases in which fetal ultrasound was performed at our hospital between January 1, 2013 and March 31, 2023 and congenital heart disease was diagnosed prenatally or postnatally, and presented the results at the 97th Academic Meeting of the Japan Society of Ultrasound in Medicine on June 1, 2024.
Adverse events	Between January 1, 2013 and March 31, 2023, 94 cases were identified in which fetal ultrasound was performed at our hospital and congenital heart disease was diagnosed prenatally or postnatally.
Outcome measures	There were 36 cases of congenital heart disease diagnosed prenatally and postnatally before the introduction of color Doppler, and 58 cases after that. Before the introduction of color Doppler, there were 20 cases (55.6%) in which congenital heart disease could be detected prenatally, but after the introduction of color Doppler, the number of cases in which congenital heart disease could be detected prenatally increased significantly to 49 cases (84.5%) (P < 0.01). In particular, for isolated ventricular septal defect (VSD) without other cardiac or systemic disease, 7 out of 22 cases (31.8%) were diagnosed in the fetal stage before the introduction of color Doppler, but after the introduction of color Doppler, the number significantly increased to 32 out of 40 cases (80.0%) (P < 0.01). After the introduction of color Doppler, there was a case of aortic coarctation with VSD that was diagnosed in the fetal stage, and it was thought that color Doppler enabled the patient to be referred to a higher-level medical institution before birth. There were six cases of tricuspid regurgitation (TR) that were examined prenatally, two of which had mild Ebstein's disease and were followed up after birth, in which color Doppler imaging was deemed useful.
Brief summary	The use of color Doppler in combination with 4CV in fetal echocardiographic screening increased the detection rate of congenital heart disease. Color Doppler is considered useful for detecting congenital heart disease.
Date of posting of results summaries	June. 01, 2024

Plan to share IPD	No
URL link to protocol file(s) with version and date	https://jrct.mhlw.go.jp/latest-detail/jRCT1062230101

Contact for Scientific Queries	Name	Masumoto Akio
	Affiliation	Masumoto ladies clinic
	Address	2-7-22 Aita, Asa Minami-ku, Hiroshima City, Hiroshima Prefecture
	Telephone	+81-82-878-1111
	E-mail	massun14@yahoo.co.jp
Contact for Public Queries	Name	Masumoto Akio
	Affiliation	Masumoto ladies clinic
	Address	2-7-22 Aita, Asa Minami-ku, Hiroshima City, Hiroshima Prefecture
	Telephone	+81-82-878-1111
	E-mail	massun14@yahoo.co.jp

Recruitment status	Complete


Anticipated date of first enrollment		Jan. 01, 2013
Actual date of first enrollment		May. 02, 2013
Target sample size		100
Study Type		Observational
Key inclusion & exclusion criteria	Inclusion Criteria	Children diagnosed with congenital heart disease during the fetal or neonatal period after undergoing a prenatal checkup at our hospital and undergoing fetal echocardiography during regular medical treatment.
	Exclusion Criteria	Children with no congenital heart disease after birth
	Age Minimum	No limit
	Age Maximum	No limit
Health Condition(s) or Problem(s) Studied		Heart Defects, Congenital
Health Condition(s) Code		D006330
Primary Outcome(s)		Detection rate of congenital heart defects

Primary Sponsor	Masumoto ladies clinic

Name of Certified Review Board	Hiroshima Medical Association Clinical Research Ethics Review Board
Address	3-2-3 Futabanosato, Higashi-ku, Hiroshima City, Hiroshima
Telephone	+81-82-568-1511
E-Mail	gaku@hiroshima.med.or.jp
Approval Status	Approval
Date of approval	Jan. 26, 2024

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
2	Jan. 10, 2025	(this page)	Changes
1	Feb. 08, 2024	Detail

List of change history