A Phase 1 interventional study of amnioinfusion procedure in Severe Oligohydramnios, sponsored by Szeged University. Status unknown at 1 site in Hungary. Open to female participants aged 18 Years to 49 Years. Per ClinicalTrials.gov, last updated 2010-12-13.
Sponsored by Szeged University · Phase 1, Interventional, and Diagnostic
The aim of this study is to compare the uteroplacental and pulmonary circulation of the fetuses with severe (AFI\<5cm) idiopathic oligohydramnios (with unknown origin) to those in normal controls. Further purpose of the study is to measure the changes of the uteroplacental and fetal pulmonary circulation in patients presenting with severe idiopathic oligohydramnios, managed either with single amnioinfusion or with serial amnioinfusions.
Severe oligohydramnios (AFI\<5) is an uncommon complication of pregnancy and it is often associated with Preterm Premature Rupture of the Membranes (pPROM) or with the lethal congenital abnormality. However, in very few cases it is idiopathic (with no obvious etiopathology) and in the prevention of fetal complication (e.g. pulmonary hypoplasia) the amnioinfusion is a treatment option for the persisting oligohydramnios.
Severe oligohydramnios for >14 days had a predicted mortality rate >90%. Although severe oligohydramnios and pPROM may lead to pulmonary hypoplasia, all of these three factors are independent predictors of pulmonary hypertension. It is obvious that there are some alterations in the fetal pulmonary circulation in cases of severe oligohydramnios.
The preliminary study shows that single/serial amnioinfusion has some beneficial effects on the outcome of the pregnancies complicated with severe idiopathic oligohydramnios: to prolong the gestation, to reduce the number of premature labor and to prevent the adverse neonatal outcome.
The investigators propose an open trial comparing baseline Doppler waveforms in the uteroplacental and fetal pulmonary circulation in patients presenting with severe, idiopathic olighydramnios (AFI\<5, no apparent ethiopathology), managed either with single or with serial amnioinfusions and in matched controls (matched in gestational age, parity and gravidity, AFI>8). The patients will be followed up weekly in the fetomaternal unit, Dept. of ObGyn for measuring AFI repeatedly to assess the need for further infusions. These will be carried out when the AFI falls below 5cm again.
Inclusion criteria: Single pregnancy, severe (AFI\<4 cm), idiopathic oligohydramnios between the 18 and 34 weeks of gestation. The study is open and will be run by a single ultrasonographer to avoid interobserver bias, and with a set of minimal number of outcome measures recorded. Primary outcome: Doppler waveforms of the uteroplacental and fetal pulmonary circulation.
Alterations in Doppler indices of the Ductus venosus, arteria umbilicalis, arteria uterina, left and right arterial pulmonary branches: (1) systolic/diastolic ratio (S/D), (2) peak systolic velocity; (3) time-averaged velocity; (4) maximum forward velocity during atrial contraction; (5) pulsatility index (PI); (6) Pourcelot's resistance index (RI).
The pulsed Doppler measurements of the arterial pulmonary branches will be carried out from a transverse cross-section of the fetal chest at the level of the cardiac 4-chamber view after visualization with color Doppler. Depending on fetal position, the right or left lung will be examined. Doppler waveforms (sample volume: 0.1-0.3 cm) will be first obtained from the most proximal branch of the pulmonary artery, then in the middle lung region at equal distance from the outer border of the heart and the inner thoracic wall and subsequently in the distal lung region as close as possible to the fetal inner thoracic wall.
Secondary outcomes: Alterations of the Doppler waveforms during the progress of the pregnancy.
25 studies on the registry are indexed under Oligohydramnios; 5 are open to participants now.
This study's planned enrollment of 40 is below the median of 91 across 16 interventional studies indexed under Oligohydramnios.
Browse Oligohydramnios studies →Szeged University is the lead sponsor of 56 studies on the registry; 8 are open to participants now.
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Exclusion Criteria:
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Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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The human immunodeficiency virus, which weakens the immune system.
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Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
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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.
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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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
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.
The investigators propose an open trial comparing baseline Doppler waveforms in the uteroplacental and fetal pulmonary circulation in patients presenting with severe, idiopathic olighydramnios (AFI\<5, no apparent ethiopathology), managed either with single or with serial amnioinfusions. The patients will be followed up weekly in the fetomaternal unit, Dept. of ObGyn for measuring AFI repeatedly to assess the need for further infusions. These will be carried out when the AFI falls below 5cm again
Procedure: amnioinfusion procedure
Single/serial amnioinfusions aimed at restoring amniotic fluid volume until a normal amount (AFI≥8cm).(Every pregnant women presenting with severe (AFI\<5) idiopathic (with unknown origin) oligohydramnios is treated with amnioinfusion at our Dept.)
Also known as: restoring amniotic fluid volume with intraamniotic transfusion of saline infusion
Doppler waveforms of the uteroplacental and fetal pulmonary circulation following amnioinfusion
Time frame: reaching 34 weeks of gestation
Alterations of the Doppler waveforms during the progress of the pregnancy following amnioinfusion
Time frame: reaching 34 weeks of gestation
The record gives a start of Jan 2011, a primary completion of Sep 2011 and a completion of Dec 2012. It does not say whether these dates are actual or estimated.
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This study is status unknown, as verified in Dec 2010. You cannot join it, but the record below documents what was studied.
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Szeged University