Clinical trial NCT00787163: Amnioinfusion Initiative
Official title: Open Randomized Trial Comparing Perinatal Outcome Following Expectant Management Versus Amnioinfusion in PPROM <25 Wks With Persistent Oligohydramnios
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Oligohydramnios
Keywords: pPROM
oligohydramnios
amnioinfusion
prematurity
Early premature rupture of membranes in pregnancy
Lead sponsor: Università degli Studi di Brescia
Sponsor class: OTHER
Collaborators: name: KU Leuven
name: University of Milan
name: Catholic University, Italy
First posted: 2008-11-07
Enrollment: 82
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 prior to 24 weeks. When oligohydramnios persists, it may raise to 90%. Morbidity in survivors is also significant. In uncontrolled series, serial amnioinfusions, which have acceptable invasiveness and are of limited complexity, mortality was reduced to 60%.

We propose an open, multicenter randomized trial comparing perinatal survival in patients presenting with early spontaneous PPROM and persistent oligohydramnios, managed either conservatively or with serial amnioinfusions. Inclusion criteria: Single pregnancy, early spontaneous PPROM \< 24.3 weeks, oligohydramnios (deepest vertical pocket \< 2 cm) for at least 4 days and no longer than 15 days at enrolment. The study is open and will be run through a dedicated password protected web site, and with a minimal number of outcome measures. Primary outcome: Survival till discharge from the NICU. Secondary outcomes: Latency time from PPROM to delivery, gestational age at birth, indication for delivery, number of days of ventilatory support, serious neurologic morbidity, neonatal sepsis prevalence, need for oxygen at 36 weeks post-conception.

Eligibility criteria: Inclusion Criteria:

1. Patients above 18 years, who are able to consent, with
2. Singleton pregnancy
3. with a normal structural examination as much as possible;
4. At least 2 US examination after pPROM for gestational age confirmation and diagnosis of persistent oligohydramnios
5. Follow up ultrasound examinations weekly in the treatment group
6. Acceptance of randomisation and to comply with the protocol

Exclusion Criteria:

1. Maternal contra-indications to intervention or prolongation of pregnancy, including severe medical conditions in pregnancy that make fetal intervention riskful;
2. Preterm labour defined as contractions \>6/hour associated with cervical changes, cervix shortened (\<15 mm at randomization),
3. Cervical cerclage in place
4. 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
5. Fetal structural anomaly detected at prenatal ultrasonography, or fetal chromosomal abnormalities involving autosomes
6. Previous invasive procedure in this index pregnancy
7. Fetal condition mandating immediate delivery
8. Severe bleeding
9. Maternal HIV and HCV infection
10. Multiple gestation

Primary outcomes:
measure: Survival of neonates/infants at discharge after serial amnioinfusions compared to survival after expectant management
timeFrame: discharge of every neonate from NICU
Secondary outcomes:
measure: Gestational age of delivery (main secondary outcome)
timeFrame: time of delivery for every case
Other outcomes:
Locations:
city: Monza
country: Italy
facility: University of Milano Bicocca, Ospedale san Gerardo Monza
state: Milano
Study officials:
affiliation: University of Milano Bicocca
name: Anna Locatelli, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Milano Bicocca
name: Patrizia Vergani, MD
role: STUDY_CHAIR
References: