UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037988 |
|---|---|
| Receipt number | R000043301 |
| Scientific Title | Examination of the quantitative relationship between thyroid hormone (freeT4) and thyroid stimulating hormone (TSH) in amniotic fluid and umbilical cord blood |
| Date of disclosure of the study information | 2019/09/11 |
| Last modified on | 2021/03/16 09:43:16 |
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Basic information
Public title
Examination of the quantitative relationship between thyroid hormone (freeT4) and thyroid stimulating hormone (TSH) in amniotic fluid and umbilical cord blood
Acronym
Examination of the quantitative relationship between thyroid hormone (freeT4) and thyroid stimulating hormone (TSH) in amniotic fluid and umbilical cord blood
Scientific Title
Examination of the quantitative relationship between thyroid hormone (freeT4) and thyroid stimulating hormone (TSH) in amniotic fluid and umbilical cord blood
Scientific Title:Acronym
Examination of the quantitative relationship between thyroid hormone (freeT4) and thyroid stimulating hormone (TSH) in amniotic fluid and umbilical cord blood
Region
| Japan |
Condition
Condition
a pregnant woman
Classification by specialty
| Endocrine surgery | Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the quantitative relationship between thyroid hormone (freeT4) and thyroid stimulating hormone (TSH) in amniotic fluid and cord blood.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Correlation between freeT4 and TSH in amniotic fluid and umbilical cord blood
Key secondary outcomes
Normal values of amniotic fluid freeT4 and TSH
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
1) Singleton pregnancy.
2) A pregnant woman undergoing selective cesarean section for obstetrics and gynecology at the Department of Obstetrics and Gynecology, Showa University Northern Yokohama Hospital.
3) Pregnant women who are over 20 years old when obtaining consent.
4) Pregnant women whose consent was obtained in writing
Key exclusion criteria
1) Multiple pregnancy. (In the case of multiple fetuses, there is a possibility that the amniotic fluid between fetuses may be mixed)
2) When there is a lot of bleeding in the hysterotomy wound and there is a high possibility that maternal blood and amniotic fluid are mixed.
3) If a rupture occurs simultaneously with a hysterotomy.
4) When it is difficult to collect amniotic fluid due to lack of amniotic fluid, etc.
5) When it seems difficult to collect umbilical cord blood for reasons such as umbilical cord disconnection.
6) A pregnant woman who has undergone a test using a contrast medium within half a year of pregnancy.
7) Pregnant women who have been diagnosed with fetal heartbeat abnormalities or fetal growth failure on examination before cesarean section.
8) A pregnant woman with a malignant tumor.
9) Pregnant women suffering from serious liver / kidney disorders or heart disease that may affect drug safety assessment.
10) When it is judged that the mother and child are in a dangerous situation.
11) A pregnant woman who is judged to be ineligible at the discretion of the research doctor.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Mitsuhiro |
| Middle name | |
| Last name | Fukushima |
Organization
Showa University Northern Yokohama Hospital
Division name
Surgery in Thyroid Center
Zip code
224-8503
Address
35-1, Chigasaki-chuo, Tsuzuki-ku, Yokohama, Kanagawa, JAPAN
TEL
0459497000
fukushima-m@med.showa-u.ac.jp
Public contact
Name of contact person
| 1st name | Mitsuhiro |
| Middle name | |
| Last name | Fukushima |
Organization
Showa University Northern Yokohama Hospital
Division name
Thyroid Center
Zip code
224-8503
Address
35-1, Chigasaki-chuo, Tsuzuki-ku, Yokohama, Kanagawa, JAPAN
TEL
0459497000
Homepage URL
fukushima-m@med.showa-u.ac.jp
Sponsor or person
Institute
Thyroid Center, Showa University Northern Yokohama Hospital
Institute
Department
Personal name
Funding Source
Organization
Thyroid Center, Showa University Northern Yokohama Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Roche Diagnostics K.K.
Name of secondary funder(s)
Research support program
IRB Contact (For public release)
Organization
Institutional Review Board, Showa University Northern Yokohama Hospital
Address
35-1, Chigasaki-chuo, Tsuzuki-ku, Yokohama, Kanagawa, JAPAN
Tel
0459497000
irb02syh@ofc.showa-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
| 2019 | Year | 09 | Month | 11 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2019 | Year | 08 | Month | 29 | Day |
Date of IRB
| 2019 | Year | 08 | Month | 29 | Day |
Anticipated trial start date
| 2019 | Year | 09 | Month | 11 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2021 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2021 | Year | 09 | Month | 30 | Day |
Other
Other related information
On the day before cesarean section, 2 ml of maternal blood is collected as a research sample in addition to normal blood collection.
Perform cesarean section as usual until lower uterine exposure: laparotomy
At the stage where the lower uterus can be exposed, intraoperative ultrasound is used to confirm the position of the fetus and appendages, then the lower uterine muscle layer is incised to confirm the uveal bulge, and the bulge is punctured with a 20-gauge needle. Collect 2 mL of amniotic fluid.
Child delivery and placenta delivery after artificial rupture. Thereafter, uterine suture and abdomen are performed as usual cesarean section.
After fetal delivery, normal umbilical arterial blood is collected, and 2 ml of umbilical venous blood is collected from the umbilical vein as a research sample.
TSH and freeT4 in amniotic fluid, umbilical vein blood, and maternal blood are measured by ECLIA method.
Management information
Registered date
| 2019 | Year | 09 | Month | 11 | Day |
Last modified on
| 2021 | Year | 03 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043301
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