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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000023778
Receipt No. 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

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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
Obsterics 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
Email 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
Email tadafer.study@gmail.com

Sponsor
Institute Mie university hospital, Department of Obstetrics and Gynecology
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027132

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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