Amnioinfusion Initiative

Sponsor

Università degli Studi di Brescia (Other)

Overall Status

Unknown status

CT.gov ID

NCT00787163

Collaborator

KU Leuven (Other), University of Milan (Other), Catholic University, Italy (Other)

Enrollment

Location

Arms

Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Oligohydramnios	Procedure: amnioinfusion	Phase 3

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

82 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Open Randomized Trial Comparing Perinatal Outcome Following Expectant Management Versus Amnioinfusion in PPROM <25 Wks With Persistent Oligohydramnios

Study Start Date :

Sep 1, 2008

Anticipated Primary Completion Date :

Sep 1, 2011

Anticipated Study Completion Date :

Dec 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 amnioinfusion	Procedure: amnioinfusion serial amnioinfusions aimed at restoring amniotic fluid volume
No Intervention: 2 expectant management

Arm

Intervention/Treatment

Experimental: 1

amnioinfusion

Procedure: amnioinfusion

serial amnioinfusions aimed at restoring amniotic fluid volume

No Intervention: 2

expectant management

Outcome Measures

Primary Outcome Measures

Survival of neonates/infants at discharge after serial amnioinfusions compared to survival after expectant management [discharge of every neonate from NICU]

Secondary Outcome Measures

Gestational age of delivery (main secondary outcome) [time of delivery for every case]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

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 Criteria:

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