UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000027270
Receipt number 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 13:49:37

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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

Obstetrics 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 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


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

Value
https://center6.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