Clinical Trial: Alterations of the Uteroplacental and Fetal Pulmonary Circulation Following Amnioinfusion

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Alterations of the Uteroplacental and Fetal Pulmonary Circulation in Patients With Severe Idiopathic Oligohydramnios Following Amnioinfusion Therapy in a Longitudinal Stud

Brief Summary: 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.

Detailed Summary:

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 1
Sponsor: Szeged University

Current Primary Outcome: Doppler waveforms of the uteroplacental and fetal pulmonary circulation following amnioinfusion [ Time Frame: reaching 34 weeks of gestation ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Alterations of the Doppler waveforms during the progress of the pregnancy following amnioinfusion [ Time Frame: reaching 34 weeks of gestation ]

Original Secondary Outcome: Same as current

Information By: Szeged University

Dates:
Date Received: December 7, 2010
Date Started: January 2011
Date Completion: December 2012
Last Updated: December 10, 2010
Last Verified: December 2010