UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011792 |
|---|---|
| Receipt number | 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 14:00:59 |
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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
| Obstetrics 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
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
| 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
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
eisho@saitama-med.ac.jp
Sponsor or person
Institute
Saitama Medical Center
Department of Obstetrics and Gynecology(Center for Maternal , Fetal and Neonatal Medicine)
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008488
