UMIN-CTR Clinical Trial

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 Obsterics 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
Email	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
Email	fukushima-m@med.showa-u.ac.jp

Sponsor
Institute	Thyroid Center, Showa University Northern Yokohama Hospital
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000043301