Amnioinfusion Initiative

NCT ID: NCT00787163

Last Updated: 2009-01-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 82 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-09-30
• Study Completion Date: 2013-12-31

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.

Conditions

Oligohydramnios

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

amnioinfusion

Group Type: EXPERIMENTAL

amnioinfusion

Intervention Type: PROCEDURE

serial amnioinfusions aimed at restoring amniotic fluid volume

2

expectant management

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

amnioinfusion

serial amnioinfusions aimed at restoring amniotic fluid volume

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

KU Leuven

OTHER

Sponsor Role: collaborator

University of Milan

OTHER

Sponsor Role: collaborator

Catholic University, Italy

OTHER

Sponsor Role: collaborator

Università degli Studi di Brescia

OTHER

Sponsor Role: lead

Responsible Party

University of Milano Bicocca

Principal Investigators

Anna Locatelli, MD

Role: PRINCIPAL_INVESTIGATOR

University of Milano Bicocca

Patrizia Vergani, MD

Role: STUDY_CHAIR

University of Milano Bicocca

Locations

University of Milano Bicocca, Ospedale san Gerardo Monza

Monza, Milano, Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Anna Locatelli, MD

Role: CONTACT

anna.locatelli@unimib.it

+39 039 233 4720

Facility Contacts

Anna Locatelli, MD

Role: primary

anna.locatelli@unimib.it

+390392334720

Other Identifiers

Amnioinfusion-001

Identifier Type: -

Identifier Source: org_study_id