CompletedEarly Phase 1ACTRN12610000180011

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


Sponsor

National Science Council

Enrollment

40 participants

Start Date

May 1, 2005

Study Type

Interventional

Conditions

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.


Eligibility

Sex: Both males and females

Plain Language Summary

Simplified for easier understanding

This study evaluates the effectiveness of a procedure called pleurodesis (sealing the space around the lungs) to treat fluid buildup in the lungs of unborn babies. It is for pregnancies where the fetus has been diagnosed with fluid in both lung spaces and has a normal chromosomal makeup.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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

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.


Locations(1)

Taiwan, Province Of China

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ACTRN12610000180011