Amnioinfusion Initiative

Phase 3

• Conditions: Oligohydramnios
• Interventions: Procedure: amnioinfusion

• Registration Number: NCT00787163
• Lead Sponsor: Università degli Studi di Brescia

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.

Study Timeline

• Study Start: 2008-09
• Status Verified: 2008-11
• Study First Submitted: 2008-11-06
• Study First Submitted QC: 2008-11-06
• Study First Posted: 2008-11-07
• Last Update Submitted: 2009-01-21
• Last Update Posted: 2009-01-22
• Primary Completion: 2011-09
• Study Completion: 2013-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 82

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	amnioinfusion	amnioinfusion

Primary Outcome Measures

Name	Time	Method
Survival of neonates/infants at discharge after serial amnioinfusions compared to survival after expectant management	discharge of every neonate from NICU

Secondary Outcome Measures

Name	Time	Method
Gestational age of delivery (main secondary outcome)	time of delivery for every case

Trial Locations

Locations (1)

University of Milano Bicocca, Ospedale san Gerardo Monza; 🇮🇹 Monza, Milano, Italy