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Trial registered on ANZCTR


Registration number
ACTRN12610000180011
Ethics application status
Approved
Date submitted
22/02/2010
Date registered
1/03/2010
Date last updated
1/03/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
Efficacy of Pleurodesis When Accumulation of Fluids occurs in Fetal Lungs
Scientific title
Efficacy of antenatal OK-432 Pleurodesis in Bilateral Pleural Effusion as assessed by neonatal survival rates
Universal Trial Number (UTN)
Trial acronym
OK432
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Fetal Bilateral Pleural Effusion 256864 0
Condition category
Condition code
Reproductive Health and Childbirth 257014 257014 0 0
Fetal medicine and complications of pregnancy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
diet modification (by using medium-chain triglyceride oil exclusively when cooking), followed by amniocentesis (performed at GA 16 weeks or later with ultrasound guidance under aseptic precautions) to exclude aneuploidy, followed by thoracocentesis (using a 21 gauge needle to pierce into fetal chest under ultrasound guidance under aspetic precautions), and finally OK-432 pleurodesis (a dosage of 0.1~0.5KE OK-432 per side was used after thoracocentesis to drain dry the pleural fluids and will be repeated two weeks later if pleural effusions recur, a maximun of three treatments will be adopted).
The duration of amniocentesis itself (we only calculate the duration when the needle is in the amniotic cavity) is less than 30 seconds. The duration of thoracocentesis will be longer since we need to aspirate all the pleural fluids and it usually took less than 3 minutes. The duration of OK-432 pleurodesis is the sum of the duration of thoracocentesis plus the duration of instillating the medication. The time cost in unilateral pleurodesis is usually less than 5 minutes, and thus the duration of bilateral pleurodesis is less than 10 minutes. Gestation ages of the fetuses ranged from GA(gestational age) 16 weeks to 29 weeks.
Intervention code [1] 256060 0
Treatment: Other
Intervention code [2] 256073 0
Treatment: Drugs
Intervention code [3] 256074 0
Treatment: Surgery
Comparator / control treatment
Nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 257909 0
Intrauterine death or livebirth but neonatal death or survival beyond the newborn stage
--by data linkage to medical records
Timepoint [1] 257909 0
when pregnancy is terminated, either due to fetal death, or for livebirth delivery; and at age 1 month
Secondary outcome [1] 263379 0
responses include poor response, partial response, or total remission

Poor response is defined as progression or no improvement of disease. Partial response is defined as lessening of severity of disease but not complete remission. Total remission means disappearance of pleural effusion.

The main tool used for evalutaion is ultrasound.
Timepoint [1] 263379 0
two weeks after OK-432 pleurodesis and will be followed fortnightly until end outcome occurs, including livebirths, delivery of dead fetus, or termination of the pregnancy with alive fetus before GA 24 weeks.

Eligibility
Key inclusion criteria
Fetal Bilateral Pleural Effusions
(onset at any gestational period)
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Those with abnormal karyotype ascertained by amniocentesis or other invasive methods

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
fetuses with bilateral pleural effusions are enrolled initially. They were given diet modification first for one week, then those without response would receive amniocentesis; after the karyotype was availabe after one week, those with normal karyotype would receive thoracocentesis; and only those with lymphocyte-rich pleural fluids would enter the treatment group if no spontaneous remission occurred. OK-432 pleurodesis would be performed in the treatment group and the fetuses would be followed up fortnightly.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
NA
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 0
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/05/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment outside Australia
Country [1] 2520 0
Taiwan, Province Of China
State/province [1] 2520 0

Funding & Sponsors
Funding source category [1] 256563 0
Hospital
Name [1] 256563 0
Changhua Christian Hospital
Country [1] 256563 0
Taiwan, Province Of China
Primary sponsor type
Government body
Name
National Science Council
Address
106, Sec. 2, Heping E. Rd., Taipei City 10622, Taiwan (R.O.C.)
Country
Taiwan, Province Of China
Secondary sponsor category [1] 255857 0
Hospital
Name [1] 255857 0
National Taiwan University Hospital
Address [1] 255857 0
No.1, Chang-Te Street, Taipei City 10048
Country [1] 255857 0
Taiwan, Province Of China
Other collaborator category [1] 1136 0
Hospital
Name [1] 1136 0
Mackay Memorial Hospital
Address [1] 1136 0
No. 92, Sec.2, Zhongshan N. Rd., Taipei City 10449
Country [1] 1136 0
Taiwan, Province Of China

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258599 0
The Institution Review Board, Changhua Christian Hospital (CCH-IRB)
Ethics committee address [1] 258599 0
No. 135, Nanhsiao Street, Changhua City, 500
Ethics committee country [1] 258599 0
Taiwan, Province Of China
Date submitted for ethics approval [1] 258599 0
09/12/2004
Approval date [1] 258599 0
01/04/2005
Ethics approval number [1] 258599 0

Summary
Brief summary
We wished to set up the efficacy and safety data of applying OK-432 pleurodesis in human fetuses afflicted with bilateral chylothorax and followed up their outcomes as well as if there are any maternal complications.
Trial website
N/A
Trial related presentations / publications
Chen M, Shih JC, Wang BT, Chen CP, Yu CL. 2005. Fetal OK-432 pleurodesis: complete or incomplete? Ultrasound Obstet Gynecol 26: 791-793.

Chen M, Hsieh CY, Shih JC, Chou CH, Ma GC, Chen TH, Lee TH, Tsai HD, Cameron AD, Chen CP. 2007. Proinflammatory macrophage migratory inhibition factor and interleukin-6 are concentrated in pleural effusion of human fetuses with prenatal chylothorax. Prenat Diagn 27: 435-41.

Chen CH, Chen TH, Kuo SJ, Chen CP, Lee DJ, Ke YY, Yeh KT, Ma GC, Liu CS, Shih JC, Chen M. 2009. Genetic evaluation and management of fetal chylothorax: review and insights from a case of Noonan syndrome. Lymphology 42: 134-138.

Ma GC, Liu CS, Chang SP, Yeh KT, Ke YY, Chen TH, Wang BB, Kuo SJ, Shih JC, Chen M. 2008. A recurrent ITGA9 missense mutation in human fetuses with severe chylothorax: possible correlation with poor response to fetal therapy. Prenat Diagn 28: 1057-1063.
Public notes

Contacts
Principal investigator
Name 30868 0
Address 30868 0
Country 30868 0
Phone 30868 0
Fax 30868 0
Email 30868 0
Contact person for public queries
Name 14115 0
Ming Chen, MD, PhD
Address 14115 0
Department of Genomic Medicine,
Changhua Christian Hospital Medical Center,
No.176, Chunghua Rd., 3F, Changhua City 500
Country 14115 0
Taiwan, Province Of China
Phone 14115 0
+886-4-7225121 ext 2323
Fax 14115 0
+886-4-7249847
Email 14115 0
[email protected]
Contact person for scientific queries
Name 5043 0
Ming Chen, MD, PhD
Address 5043 0
Department of Genomic Medicine,
Changhua Christian Hospital Medical Center,
No.176, Chunghua Rd., 3F, Changhua City 500
Country 5043 0
Taiwan, Province Of China
Phone 5043 0
+886-4-7225121 ext 2323
Fax 5043 0
+886-4-7249847
Email 5043 0
[email protected]

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