UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023778 |
|---|---|
| Receipt number | R000027132 |
| Scientific Title | A multicenter phase II trial of the efficacy and safety of tadalafil in fetus with early-onset growth restriction. |
| Date of disclosure of the study information | 2016/08/26 |
| Last modified on | 2019/03/27 11:13:17 |
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Basic information
Public title
A multicenter phase II trial of the efficacy and safety of tadalafil in fetus with early-onset growth restriction.
Acronym
Tadalafil for fetus with early-onset growth restriction (TADAFER 2)
Scientific Title
A multicenter phase II trial of the efficacy and safety of tadalafil in fetus with early-onset growth restriction.
Scientific Title:Acronym
Tadalafil for fetus with early-onset growth restriction (TADAFER 2)
Region
| Japan |
Condition
Condition
Fetal growth restriction
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this randomized phase II trial is to assess the efficacy and safety of tadalafil in fetus with growth restriction.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase II
Assessment
Primary outcomes
Fetal growth velocity (g/day) from enrollment to birth.
Key secondary outcomes
1. Completion rate of the treatment regimen.
2. Efficacy monitoring.
2.1 Estimated fetal weight (g).
2.2 Fetal growth velocity (g/day) during two weeks from enrollment and one week after enrollment (g/day).
2.3 Fetal growth rate.
2.4 Fetal head circumference (cm).
2.5 Doppler imaging of umbilical arterial blood flow.
2.6 Deepest amniotic fluid pocket (cm).
2.7 Prolongation of gestational age at birth (days).
2.8 Birth weight (g).
2.9 Gestational age at birth.
2.10 Apgar score.
2.11 Umbilical artery pH and base excess values.
2.12 Incidence rate of preeclampsia.
2.13 Neonatal morbidity.
2.14 Offspring outcome until 1.5 years of age.
3. Safety monitoring.
3.1 Incidence rate of obstetric complications.
3.2 Perinatal mortality.
3.3 Neonatal mortality.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Arm A: The conventional management of FGR consisted of evaluation of fetal well-being by ultrasonography including Doppler imaging and fetal heart rate monitoring to evaluate possible pregnancy termination.
Interventions/Control_2
Arm B: Oral administration of Tadalafil (20mg/day) added to the conventional management. Tadalafil treatment is continued until delivery.
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) Age>=20
2) Estimated fetal weight (EFW) less than 1.5 standard deviations of the mean EFW for gestational age.
3) Gestational age between 20 + 0 and 33 + 6 weeks.
4) The expected date of confinement is determined using the criteria of the guidelines for obstetrical practice in Japan (2014).
5) Singleton pregnancy
6) Written informed consent.
Key exclusion criteria
1) A result from antepartum fetal tests consisted of ultrasonography including Doppler imaging and fetal heart rate monitoring at eligibility indicates that delivery should be attempted.
2) A history of allergy to tadalafil
3) Concurrent medications that interact adversely with tadalafil
4) Relative contraindication of tadalafil treatment due to renal disease.
5) Relative contraindication of tadalafil treatment due to liver disease.
6) Relative contraindication of tadalafil treatment due to uncontrolled arrhythmia, hypertension (BP >170/110 mmHg), and hypotension (BP <80/40 mmHg).
7) Fetus with suspected chromosomal disorder and/or multiple congenital anomalies.
8) Relative contraindication of tadalafil treatment due to retinitis pigmentosa, coagulation defect, active gastric and/or intestinal ulcer, and venous obstructive disease.
9) Attending physician decides to entry inappropriate.
Target sample size
140
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tomoaki Ikeda |
Organization
Mie university hospital
Division name
Department of Obstetrics and Gynecology
Zip code
Address
2-174 Edobashi, Tsu-city
TEL
059-232-1111
tadafer.study@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shintaro Maki, Michiko Kubo, Takashi Umekawa |
Organization
Mie university hospital
Division name
Department of Obstetrics and Gynecology
Zip code
Address
2-174 Edobashi, Tsu-city
TEL
059-232-1111
Homepage URL
tadafer.study@gmail.com
Sponsor or person
Institute
Mie university hospital, Department of Obstetrics and Gynecology
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development (AMED)
Organization
Division
Category of Funding Organization
Government offices of other countries
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
三重大学病院(三重県)
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 08 | Month | 26 | 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
Completed
Date of protocol fixation
| 2016 | Year | 08 | Month | 25 | Day |
Date of IRB
| 2016 | Year | 08 | Month | 25 | Day |
Anticipated trial start date
| 2016 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 08 | Month | 26 | Day |
Last modified on
| 2019 | Year | 03 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027132
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