Status:
UNKNOWN
Alterations of the Uteroplacental and Fetal Pulmonary Circulation Following Amnioinfusion
Lead Sponsor:
Szeged University
Conditions:
Severe Oligohydramnios
Eligibility:
FEMALE
18-49 years
Phase:
PHASE1
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. Fur...
Detailed Description
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. H...
Eligibility Criteria
Inclusion
- Patients above 18 years, who are able to consent;
- Singleton pregnancy;
- Normal structural examination between 16 and 20 weeks of gestation;
- Gestation between 18 and 34 weeks (the pregnancy duration determined by ultrasound verification within the 20th week);
- At least two US examinations at the presentation for confirmation and for the diagnosis of persistent oligohydramnios;
- Follow up ultrasound examinations weekly in both groups.
Exclusion
- 1\. pPROM; 2. Fetal structural anomaly detected at prenatal ultrasonography, or fetal chromosomal abnormalities involving autosomes; 3. Symptoms referring incomplete abortion before 24 weeks of gestation; 4. Maternal contraindications to intervention or prolongation of pregnancy, including severe medical conditions in pregnancy that make the intervention riskful; 5. No active premature labor (shortened cervix \<15 mm, \<3 cm of cervical dilatation; \>6/hour uterine contractions) after 24 weeks of gestation; 6. Cervical cerclage in place; 7. Clear signs of maternal or fetal infection (2 or more of the following: maternal tachycardia \>100/min, maternal temperature \>38°C, maternal white blood count cells (WBC) \>15,000/ml, maternal C-reactive protein (CRP) \>20 mg/l, uterine tenderness, foul-smelling vaginal discharge, fetal tachycardia \>160 bpm); 8. Suspicion of placental abruption (uterine tenderness and bleeding episodes); 9. Previous invasive procedure in the pregnancy; 10. Fetal condition mandating immediate delivery; 11. Severe bleeding at present; 12. Maternal HIV and HBV/HCV infection; 13. Multiple gestation.
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Key Trial Info
Start Date :
January 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2012
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT01258725
Start Date
January 1 2011
End Date
December 1 2012
Last Update
December 13 2010
Active Locations (1)
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1
University of Szeged, Department of Obstetrics and Gynecology
Szeged, Hungary, H-6725