Amnioinfusion Initiative

NCT00787163 | Unknown Phase 3 DMC

• 1 other identifier: Amnioinfusion-001
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

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.

Conditions

Oligohydramnios

Keywords

pPROM; oligohydramnios; amnioinfusion; prematurity; Early premature rupture of membranes in pregnancy

Outcome Measures

Primary Outcomes (1)

• Survival of neonates/infants at discharge after serial amnioinfusions compared to survival after expectant management

  discharge of every neonate from NICU

Secondary Outcomes (1)

• Gestational age of delivery (main secondary outcome)

  time of delivery for every case

Study Arms (2)

1

EXPERIMENTAL

amnioinfusion

Procedure: amnioinfusion

2

NO INTERVENTION

expectant management

Interventions

amnioinfusion PROCEDURE

serial amnioinfusions aimed at restoring amniotic fluid volume

1

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Università degli Studi di Brescia: lead
• KU Leuven: collaborator
• University of Milan: collaborator
• Catholic University, Italy: collaborator

Study Sites (1)

University of Milano Bicocca, Ospedale san Gerardo Monza

Monza, Milano, 20052, Italy

RECRUITING

MeSH Terms

Conditions

Oligohydramnios; Preterm Premature Rupture of the Membranes; Premature Birth

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Obstetric Labor, Premature; Obstetric Labor Complications

Study Officials

• Anna Locatelli, MD

  University of Milano Bicocca

  PRINCIPAL INVESTIGATOR

• Patrizia Vergani, MD

  University of Milano Bicocca

  STUDY CHAIR

Central Study Contacts

Anna Locatelli, MD

CONTACT

+39 039 233 4720; anna.locatelli@unimib.it

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 6, 2008
• First Posted: November 7, 2008
• Study Start: September 1, 2008
• Primary Completion: September 1, 2011
• Study Completion: December 1, 2013
• Last Updated: January 22, 2009

Record last verified: 2008-11

Locations

IT (1)