A Phase 3 interventional study of amnioinfusion in Oligohydramnios, sponsored by Università degli Studi di Brescia. Status unknown at 1 site in Italy. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2009-01-22.
Sponsored by Università degli Studi di Brescia · Phase 3, Interventional, and Treatment
The aim of this study is to compare perinatal survival in patients presenting with early spontaneous PPROM and persistent oligohydramnios, managed either conservatively or with serial amnioinfusions.
Early spontaneous Preterm Premature Rupture of Membranes (PPROM) is associated with high perinatal mortality. Due to pulmonary hypoplasia and preterm delivery, mortality exceeds 60% when PPROM occurs prior to 24 weeks. When oligohydramnios persists, it may raise to 90%. Morbidity in survivors is also significant. In uncontrolled series, serial amnioinfusions, which have acceptable invasiveness and are of limited complexity, mortality was reduced to 60%.
We propose an open, multicenter randomized trial comparing perinatal survival in patients presenting with early spontaneous PPROM and persistent oligohydramnios, managed either conservatively or with serial amnioinfusions. Inclusion criteria: Single pregnancy, early spontaneous PPROM \< 24.3 weeks, oligohydramnios (deepest vertical pocket \< 2 cm) for at least 4 days and no longer than 15 days at enrolment. The study is open and will be run through a dedicated password protected web site, and with a minimal number of outcome measures. Primary outcome: Survival till discharge from the NICU. Secondary outcomes: Latency time from PPROM to delivery, gestational age at birth, indication for delivery, number of days of ventilatory support, serious neurologic morbidity, neonatal sepsis prevalence, need for oxygen at 36 weeks post-conception.
25 studies on the registry are indexed under Oligohydramnios; 5 are open to participants now.
This study's planned enrollment of 82 is close to the median of 91 across 16 interventional studies indexed under Oligohydramnios.
Browse Oligohydramnios studies →Università degli Studi di Brescia is the lead sponsor of 47 studies on the registry; 3 are open to participants now.
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Exclusion Criteria:
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The human immunodeficiency virus, which weakens the immune system.
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Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
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HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
amnioinfusion
Procedure: amnioinfusion
expectant management
serial amnioinfusions aimed at restoring amniotic fluid volume
Survival of neonates/infants at discharge after serial amnioinfusions compared to survival after expectant management
Time frame: discharge of every neonate from NICU
Gestational age of delivery (main secondary outcome)
Time frame: time of delivery for every case
The record gives a start of Sep 2008, a primary completion of Sep 2011 and a completion of Dec 2013. It does not say whether these dates are actual or estimated.
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This study is status unknown, as verified in Nov 2008. You cannot join it, but the record below documents what was studied.
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Università degli Studi di Brescia