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Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000011792
Receipt No. R000008488
Scientific Title The study for transfer of Nicardipine to the fetus and neonate from mothers treated with Nicardipine. -Concentrations of Nicardipine in maternal and umbilical cord blood, and breast milk-
Date of disclosure of the study information 2013/09/18
Last modified on 2013/09/18

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Basic information
Public title The study for transfer of Nicardipine to the fetus and neonate from mothers treated with Nicardipine.
-Concentrations of Nicardipine in maternal and umbilical cord blood, and breast milk-
Acronym Placental transfer and disposition in breast milk of Nicardipine.
Scientific Title The study for transfer of Nicardipine to the fetus and neonate from mothers treated with Nicardipine.
-Concentrations of Nicardipine in maternal and umbilical cord blood, and breast milk-
Scientific Title:Acronym Placental transfer and disposition in breast milk of Nicardipine.
Region
Japan

Condition
Condition Pregnancy-induced hypertension
Classification by specialty
Obsterics and gynecology Pediatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Transfer via Placenta to the fetus and breast milk of Nicaldipine from the Mother.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Concentration measured in maternal blood,Cord blood and breast milk,
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit

Not applicable
Age-upper limit

Not applicable
Gender Female
Key inclusion criteria Patients who is admitted to our institution for management of pregnancy induced hypertension and is administered Nicardipine either orally and/or intravenously to control the hypertension are included, and written informed consent is obtained.
Normal pregnant women who is admitted to our institution for delivery and written informed consent is obtained.
Key exclusion criteria Delivery before 22nd weeks of gestation (abortion).
Multiple pregnancy
Life threatening sever fetal anomaly and condition.
Life threatening complication of the mother
Patient delivered in other institution
Positive screening for HBV, HCV and HIV
Target sample size 15

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroyuki Seki
Organization Saitama Medical Center
Division name Department of Obstetrics and Gynecology(Center for Maternal , Fetal and Neonatal Medicine)
Zip code
Address 1981 Kamoda, Kawagoe, SAITAMA 350-8550, JAPAN
TEL 049-228-3681
Email h_seki@saitama-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hideyoshi Matsumura
Organization Saitama Medical Center
Division name Department of Obstetrics and Gynecology(Center for Maternal , Fetal and Neonatal Medicine)
Zip code
Address 1981 Kamoda, Kawagoe, SAITAMA 350-8550, JAPAN
TEL 049-228-3681
Homepage URL
Email eisho@saitama-med.ac.jp

Sponsor
Institute Saitama Medical Center
Department of Obstetrics and Gynecology(Center for Maternal , Fetal and Neonatal Medicine)
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization Saitama Medical Center
Department of Obstetrics and Gynecology(Center for Maternal , Fetal and Neonatal Medicine)
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2013 Year 09 Month 18 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 Enrolling by invitation
Date of protocol fixation
2011 Year 03 Month 01 Day
Date of IRB
Anticipated trial start date
2011 Year 03 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 09 Month 18 Day
Last modified on
2013 Year 09 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008488


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