Amnioinfusion Initiative

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

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.

Study Overview

• Status: Unknown
• Conditions: Oligohydramnios
• Intervention / Treatment: Procedure: amnioinfusion

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 Type: Interventional
• Enrollment (Anticipated): 82
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Anna Locatelli, MD; Phone Number: +39 039 233 4720; Email: anna.locatelli@unimib.it

Study Locations

• Italy
  • Milano
    • Monza, Milano, Italy, 20052
      • Recruiting
      • University of Milano Bicocca, Ospedale san Gerardo Monza
      • Contact: Anna Locatelli, MD; Phone Number: +390392334720; Email: anna.locatelli@unimib.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
Gestational age of delivery (main secondary outcome)	time of delivery for every case

Collaborators and Investigators

• Sponsor: Università degli Studi di Brescia
• Collaborators: KU Leuven; University of Milan; Catholic University, Italy
• Investigators: Principal Investigator: Anna Locatelli, MD, University of Milano Bicocca; Study Chair: Patrizia Vergani, MD, University of Milano Bicocca

Study record dates

Study Major Dates

• Study Start: September 1, 2008
• Primary Completion (Anticipated): September 1, 2011
• Study Completion (Anticipated): December 1, 2013

Study Registration Dates

• First Submitted: November 6, 2008
• First Submitted That Met QC Criteria: November 6, 2008
• First Posted (Estimate): November 7, 2008

Study Record Updates

• Last Update Posted (Estimate): January 22, 2009
• Last Update Submitted That Met QC Criteria: January 21, 2009
• Last Verified: November 1, 2008

More Information

Terms related to this study

• Keywords: prematurity; pPROM; oligohydramnios; amnioinfusion; Early premature rupture of membranes in pregnancy
• Additional Relevant MeSH Terms: Pregnancy Complications; Oligohydramnios
• Other Study ID Numbers: Amnioinfusion-001