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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000027270
Receipt No. R000031037
Scientific Title A study on Prevention of Hypertensive Disorders of Pregnancy who have a history of severe hypertensive disorders of pregnancy -Pre-test for multi center trial-
Date of disclosure of the study information 2017/05/15
Last modified on 2018/07/30

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Basic information
Public title A study on Prevention of Hypertensive Disorders of Pregnancy who have a history of severe hypertensive disorders of pregnancy
-Pre-test for multi center trial-
Acronym Prevention for Recurrence Of The preEClampsia with TAdalafil (PROTECTA)
Scientific Title A study on Prevention of Hypertensive Disorders of Pregnancy who have a history of severe hypertensive disorders of pregnancy
-Pre-test for multi center trial-
Scientific Title:Acronym Prevention for Recurrence Of The preEClampsia with TAdalafil (PROTECTA)
Region
Japan

Condition
Condition Hypertensive Disorders of Pregnancy
Classification by specialty
Obsterics and gynecology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To collect basic information on prevention of Hypertensive Disorders of Pregnancy who have a history of Hypertensive Disorders of Pregnancy by tadalafil.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Recurrence rate of Hypertensive Disorders of Pregnancy
Key secondary outcomes 1. Completion rate of the treatment regimen.
2. Efficacy monitoring.
2.1 Estimated fetal weight (g).
2.2 Fetal head circumference (cm).
2.3 Doppler imaging of umbilical arterial, middle cerebral arterial, uterine arterial blood flow.
2.4 Deepest amniotic fluid pocket (cm).
2.5 Prolongation of gestational age at birth (days).
2.6 Birth weight (g).
2.7 Gestational age at birth.
2.8 Apgar score.
2.9 Umbilical artery pH and base excess values.
2.10 Incidence rate of preeclampsia.
2.11 Neonatal morbidity.
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 Prevention
Type of intervention
Medicine
Interventions/Control_1 Arm A: The conventional management of prenatal checkup following [The guideline of Maternity care](Edited by Japan Society of Obstetrics and Gynecology, Japan Association of Obstetrics and Gynecology)
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) 20 years of age or older
2) History of severe Hypertensive disorders of Pregnancy that required delivery prior to 34 weeks' gestation.
3) Gestational age between 12 + 0 and 16 + 6 weeks (The expected date of confinement is determined using the criteria of the guidelines for obstetrical practice in Japan 2014.)
4) Singleton pregnancy
5) For the test participation, it has consent is obtained in writing from the patient.
Key exclusion criteria 1) A history of allergy to tadalafil
2) Concurrent medications that interact adversely with tadalafil
3) Relative contraindication of tadalafil treatment due to renal disease.
4) Relative contraindication of tadalafil treatment due to liver disease.
5) Relative contraindication of tadalafil treatment due to uncontrolled arrhythmia, hypertension (BP >170/110 mmHg), and hypotension (BP <80/40 mmHg).
6) Fetus with suspected chromosomal disorder and/or multiple congenital anomalies.
7) Relative contraindication of tadalafil treatment due to retinitis pigmentosa, coagulation defect, active gastric and/or intestinal ulcer, and venous obstructive disease.
8) Attending physician decides to entry inappropriate.
Target sample size 20

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 Makoto Tsuji,Fumi Hatano,Syoichi Magawa,Shintaro Maki,Michiko Kubo,Hiroaki Tana,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 http://www.medic.mie-u.ac.jp/sanfujinka/tadafer.html
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
2017 Year 05 Month 15 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 Open public recruiting
Date of protocol fixation
2017 Year 05 Month 15 Day
Date of IRB
Anticipated trial start date
2017 Year 05 Month 15 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
2017 Year 05 Month 08 Day
Last modified on
2018 Year 07 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031037

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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