UMIN-CTR Clinical Trial

Basic information
Public title	A multicenter phase II trial of the efficacy and safety of tadalafil with pre-eclampsia.
Acronym	Medication in Pre-Eclampsia Trial (MIE)II
Scientific Title	A multicenter phase II trial of the efficacy and safety of tadalafil with pre-eclampsia.
Scientific Title:Acronym	Medication in Pre-Eclampsia Trial (MIE)II
Region	Japan

Condition
Condition	pregnancy induced hypertension
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 treatment on pregnancy induced hypertension.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Phase II

Assessment
Primary outcomes	Enrollment-to-delivery interval (days)
Key secondary outcomes	1. Completion rate of the treatment regimen. 2. Efficacy monitoring. 2.1 Incidence rate of severe preeclampsia 2.2 Incidence rate of liver dysfunction 2.3 Incidence rate of Eclampsia 2.4 Incidence rate of pulmonary edema 2.5 Incidence rate of FGR 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 Neonatal morbidity. 2.11 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) sBP>=140 or dBP>=90 or proteinuria>=300mg/day 3) Gestational age between 20 + 0 and 33 + 6 weeks. 4) Singleton pregnancy 5) Written informed consent.
Key exclusion criteria	1)uncontrolled hypertension 2)Delivery should be attempted because of severe preeclampsia 3) 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. 4) A history of allergy to tadalafil 5) Concurrent medications that interact adversely with tadalafil 6) Relative contraindication of tadalafil treatment due to renal disease. 7) Relative contraindication of tadalafil treatment due to liver disease. 8) Relative contraindication of tadalafil treatment due to uncontrolled arrhythmia, hypertension (BP >170/110 mmHg), and hypotension (BP <80/40 mmHg). 9) Fetus with suspected chromosomal disorder and/or multiple congenital anomalies. 10) Relative contraindication of tadalafil treatment due to retinitis pigmentosa, coagulation defect, active gastric and/or intestinal ulcer, and venous obstructive disease. 11) Attending physician decides to entry inappropriate.
Target sample size	160

Research contact person
Last name of lead principal investigator	1st name Middle name Last name Tomoaki Ikeda
Organization	Mie university hospital
Division name	Department of Obstetrics & Gynecology
Zip code
Address	2-174 Edobashi Tsu-city Mie
TEL	059-232-1111
Email	tadafer.study@gmail.com

Public contact
1st name of contact person	1st name Middle name Last name Michiko Kubo, Hiroaki Tanaka, Takashi Umekawa
Organization	Mie University Faculty of Medicine
Division name	Department of Obstetrics & Gynecology
Zip code
Address	2-174 Edobashi Tsu-city Mie
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	Other
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 09 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	Completed
Date of protocol fixation	2016 Year 09 Month 08 Day
Date of IRB	2016 Year 08 Month 25 Day
Anticipated trial start date	2016 Year 10 Month 17 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 09 Month 13 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/icdr_e/ctr_view.cgi?recptno=R000027686