Efficacy of Pleurodesis When Accumulation of Fluids occurs in Fetal Lungs

Phase 1

Completed

• Conditions: Fetal Bilateral Pleural Effusion; Reproductive Health and Childbirth - Fetal medicine and complications of pregnancy

• Registration Number: ACTRN12610000180011
• Lead Sponsor: ational Science Council

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-03-01
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Fetal Bilateral Pleural Effusions
(onset at any gestational period)

Exclusion Criteria

Those with abnormal karyotype ascertained by amniocentesis or other invasive methods

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Intrauterine death or livebirth but neonatal death or survival beyond the newborn stage<br>--by data linkage to medical records[when pregnancy is terminated, either due to fetal death, or for livebirth delivery; and at age 1 month]

Secondary Outcome Measures

Name	Time	Method
responses include poor response, partial response, or total remission<br><br>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.<br><br>The main tool used for evalutaion is ultrasound.[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.]