UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055345 |
|---|---|
| Receipt number | R000054503 |
| Scientific Title | A study of morphofunctional cardiac changes in pregnant women and perinatal outcomes. |
| Date of disclosure of the study information | 2024/08/27 |
| Last modified on | 2025/08/27 13:49:55 |
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Basic information
Public title
A study of morphofunctional cardiac changes in pregnant women and perinatal outcomes.
Acronym
A study of morphofunctional cardiac changes in pregnant women.
Scientific Title
A study of morphofunctional cardiac changes in pregnant women and
perinatal outcomes.
Scientific Title:Acronym
A study of morphofunctional cardiac changes in pregnant women.
Region
| Japan |
Condition
Condition
pregnant women
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Establishment of reference values for cardiac function in pregnant women.
To compare maternal cardiac function with and without pregnancy complications.
Basic objectives2
Others
Basic objectives -Others
not specified
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
normal value
Key secondary outcomes
compare maternal cardiac function with and without pregnancy complications.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
pregnant women
Key exclusion criteria
less than 18years old
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Sumito |
| Middle name | |
| Last name | Nagasaki |
Organization
Toho University
Division name
Department of Obstetrics and Gynecology, school of Medicine
Zip code
1430015
Address
6-11-1. Omori-nishi,Ota-ku,Tokyo
TEL
03-3762-4151
sumito.nagasaki@med.toho-u.ac.jp
Public contact
Name of contact person
| 1st name | Sumito |
| Middle name | |
| Last name | Nagasaki |
Organization
Toho University
Division name
Department of Obstetrics and Gynecology, school of Medicine
Zip code
1430015
Address
6-11-1. Omori-nishi,Ota-ku,Tokyo
TEL
03-3762-4151
Homepage URL
sumito.nagasaki@med.toho-u.ac.jp
Sponsor or person
Institute
Department of Obstetrics and Gynecology, school of Medicine Toho University
Institute
Department
Personal name
Funding Source
Organization
Department of Obstetrics and Gynecology, school of Medicine Toho University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
IRB
Address
6-11-1. Omori-nishi,Ota-ku,Tokyo
Tel
03-3762-4151
omori.rinri@ext.toho-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 08 | Month | 27 | Day |
Related information
URL releasing protocol
https://obgyn.onlinelibrary.wiley.com/doi/10.1111/jog.16224
Publication of results
Published
Result
URL related to results and publications
https://obgyn.onlinelibrary.wiley.com/doi/10.1111/jog.16224
Number of participants that the trial has enrolled
66
Results
In the TTTS group, ESV was significantly lower than in the nMD group (13.3 +/- 8.4 vs 23.9 +/- 9.2 mL, p=0.001). EF and FS were higher (80.1 +/- 5.9% vs 72.2 +/- 6.4%; 42.2 +/- 6.1% vs 35.0 +/- 4.9%). HR was higher (86.3 +/- 14.9 vs 71.4 +/- 8.0 bpm, p=0.003). CO showed no significant difference among groups.
Results date posted
| 2025 | Year | 08 | Month | 27 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
A total of 66 pregnant women were included: 31 in the singleton group, 17 in the nMD group, and 18 in the TTTS group. The mean maternal age was early 30s across all groups. Maternal weight and BMI at the time of echocardiography were significantly higher in the nMD group compared with the singleton and TTTS groups. Blood pressure did not differ significantly among the groups.
Participant flow
Seventy-one women provided informed consent. Five participants were excluded due to hypertension, gestational diabetes, cardiac disease, systemic disease, or fetal anomalies. Ultimately, 66 women met the inclusion criteria and were analyzed: 31 singleton, 17 nMD, and 18 TTTS pregnancies.
Adverse events
none
Outcome measures
Primary outcomes were echocardiographic parameters: left ventricular morphology, contractility (EF, FS, ESV, EDV, SV), diastolic function (E/A ratio, tissue Doppler indices), and cardiac output. Secondary outcomes included maternal blood pressure, weight, BMI, and inferior vena cava diameter.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2022 | Year | 06 | Month | 30 | Day |
Date of IRB
| 2022 | Year | 06 | Month | 30 | Day |
Anticipated trial start date
| 2022 | Year | 06 | Month | 30 | Day |
Last follow-up date
| 2023 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2025 | Year | 01 | Month | 31 | Day |
Other
Other related information
N/A
Management information
Registered date
| 2024 | Year | 08 | Month | 27 | Day |
Last modified on
| 2025 | Year | 08 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054503
