Status:
UNKNOWN
Amnioinfusion Initiative
Lead Sponsor:
Università degli Studi di Brescia
Collaborating Sponsors:
KU Leuven
University of Milan
Conditions:
Oligohydramnios
Eligibility:
FEMALE
18-45 years
Phase:
PHASE3
Brief Summary
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.
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- Patients above 18 years, who are able to consent, with
- Singleton pregnancy
- with a normal structural examination as much as possible;
- At least 2 US examination after pPROM for gestational age confirmation and diagnosis of persistent oligohydramnios
- Follow up ultrasound examinations weekly in the treatment group
- Acceptance of randomisation and to comply with the protocol
Exclusion
- Maternal contra-indications to intervention or prolongation of pregnancy, including severe medical conditions in pregnancy that make fetal intervention riskful;
- Preterm labour defined as contractions \>6/hour associated with cervical changes, cervix shortened (\<15 mm at randomization),
- Cervical cerclage in place
- Chorioamnionitis, defined as 2 or more of the following: maternal temperature\>38 degrees, foul-smelling vaginal discharge, uterine tenderness, fetal tachycardia\>170 bpm, white blood cell count \>18,000
- Fetal structural anomaly detected at prenatal ultrasonography, or fetal chromosomal abnormalities involving autosomes
- Previous invasive procedure in this index pregnancy
- Fetal condition mandating immediate delivery
- Severe bleeding
- Maternal HIV and HCV infection
- Multiple gestation
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2013
Estimated Enrollment :
82 Patients enrolled
Trial Details
Trial ID
NCT00787163
Start Date
September 1 2008
End Date
December 1 2013
Last Update
January 22 2009
Active Locations (1)
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1
University of Milano Bicocca, Ospedale san Gerardo Monza
Monza, Milano, Italy, 20052