Alterations of the Uteroplacental and Fetal Pulmonary Circulation Following Amnioinfusion
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|ClinicalTrials.gov Identifier: NCT01258725|
Recruitment Status : Unknown
Verified December 2010 by Szeged University.
Recruitment status was: Not yet recruiting
First Posted : December 13, 2010
Last Update Posted : December 13, 2010
|Condition or disease||Intervention/treatment||Phase|
|Severe Oligohydramnios||Procedure: amnioinfusion procedure||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Alterations of the Uteroplacental and Fetal Pulmonary Circulation in Patients With Severe Idiopathic Oligohydramnios Following Amnioinfusion Therapy in a Longitudinal Study|
|Study Start Date :||January 2011|
|Estimated Primary Completion Date :||September 2011|
|Estimated Study Completion Date :||December 2012|
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.)
Other Name: 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01258725
|University of Szeged, Department of Obstetrics and Gynecology||Not yet recruiting|
|Szeged, Hungary, H-6725|
|Contact: János Sikovanyecz, M.D., Ph.D. +3662545757 email@example.com|
|Principal Investigator:||János Sikovanyecz, M.D., Ph.D.||University of Szeged, Department of Obstetrics and Gynecology|
|Study Director:||Zoltan Kozinszky, M.D., Ph.D.||Department of Obstetrics and Gynecology, University of Szeged|