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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001095
Receipt No. R000001325
Scientific Title Clinical trial of thoracoamniotic shunting for fetal pleural effusion
Date of disclosure of the study information 2008/03/28
Last modified on 2012/08/21

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Basic information
Public title Clinical trial of thoracoamniotic shunting for fetal pleural effusion
Acronym Fetal PE shunt trial
Scientific Title Clinical trial of thoracoamniotic shunting for fetal pleural effusion
Scientific Title:Acronym Fetal PE shunt trial
Region
Japan

Condition
Condition Fetal pleural effusion
Classification by specialty
Obsterics and gynecology Pediatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy and safety of thoracoamniotic shunting for fetal pleural effusion.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Infant survival over 28 days of age
Key secondary outcomes Reversal of hydrops, adverse events, complications of shunting

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment Maneuver
Interventions/Control_1 A shunt catheter (double bascket) is placed percutaneously between the fetal thorax and the amniotic fluid space under ultrasound guidance. For bilateral pleural effusions, shunt catheters are placed in both sides. In case of failure or reaccumulation of effusion, two more attempts are allowed to place the catheter in each side.
Interventions/Control_2
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
16 years-old <=
Age-upper limit
45 years-old >
Gender Female
Key inclusion criteria 1) Between 18 weeks and 33 weeks 6 days gestation
2) Singletone pregnancy
3) Massive unilateral/bilateral pleural effusion of the fetus detected ultrasound within four days
4) Reaccumulation of fetal pleural effusion after thoracocentesis in seven days
5) Written consents to the trial from the mother and her husband
Key exclusion criteria 1) Following ultrasound findings of the fetus detected within four days
a. Anomaly except bronchopulmonary sequestration, cleft lip and palate, minor anomaly of fingers
b. Tachycardia more than 200 bpm
c. Bradycardia below 60 bpm
d. Brain calcification
e. Fetal anemia suspected by increased peak flow velocity of middle cerebral artery
2) Prior treatment for fetal pleural effusion except thoracocentesis
3) Positive indirect Coombs test
4) Chromosomal abnormality except Down syndrome
5) Mirror syndrome
6) Pregnancy induced hypertension
7) Genital bleeding
8) Short cervical length (<10mm)
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Haruhiko Sago MD PhD
Organization National Center for Child Health and Development
Division name Department of Perinatal Medicine and Maternal Care
Zip code
Address 2-10-1 Okura, Setagaya-ku, Tokyo 157-8535, Japan
TEL 03-3416-0181
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Japan Clinical Research Support Unit
Division name Department of Pediatric Research
Zip code
Address
TEL 03-5297-6258
Homepage URL http://www.crsu.org
Email kuri@crsu.org

Sponsor
Institute Japan Fetal Therapy Group (Fetusjapan)
Institute
Department

Funding Source
Organization Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

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

Other administrative information
Date of disclosure of the study information
2008 Year 03 Month 28 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
A total of 24 cases were treated; hydrops was present in 17/24 (70.8%). Median gestational age at shunting and delivery was 27.4 and 34.8 weeks, respectively. 
The overall survival rate was 79.2% (19/24), and was 70.6% (12/17) in hydropic fetuses.
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
2008 Year 02 Month 25 Day
Date of IRB
Anticipated trial start date
2008 Year 04 Month 01 Day
Last follow-up date
2010 Year 09 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2008 Year 03 Month 25 Day
Last modified on
2012 Year 08 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001325

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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