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Amnioinfusion Initiative

NCT00787163 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 82

Last updated 2009-01-22

No results posted yet for this study

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

Interventions

PROCEDURE

amnioinfusion

serial amnioinfusions aimed at restoring amniotic fluid volume

Sponsors & Collaborators

  • KU Leuven

    collaborator OTHER

  • University of Milan

    collaborator OTHER

  • Catholic University, Italy

    collaborator OTHER

  • Università degli Studi di Brescia

    lead OTHER

Principal Investigators

  • Anna Locatelli, MD · University of Milano Bicocca

  • Patrizia Vergani, MD · University of Milano Bicocca

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-09-30
Primary Completion
2011-09-30
Completion
2013-12-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00787163 on ClinicalTrials.gov