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Efficacy of Pleurodesis When Accumulation of Fluids occurs in Fetal Lungs

Efficacy of antenatal OK-432 Pleurodesis in Bilateral Pleural Effusion as assessed by neonatal survival rates

Status
Completed
Phases
Early Phase 1
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12610000180011
Acronym
OK432
Enrollment
40
Registered
2010-03-01
Start date
2005-05-01
Completion date
Unknown
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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

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.

Sponsors

National Science Council
Lead SponsorGovernment body

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
0 to No maximum
Healthy volunteers
No

Inclusion criteria

Fetal Bilateral Pleural Effusions (onset at any gestational period)

Exclusion criteria

Those with abnormal karyotype ascertained by amniocentesis or other invasive methods

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026