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Doppler or Amniocentesis to Predict Fetal Anemia

NCT00295516 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 157

Last updated 2006-05-24

No results posted yet for this study

Summary

In pregnancies complicated by Rhesus disease, the mother has developed antibodies which cross the placenta and can cause anemia and death of the fetus. When the anemia is detected on time, the fetus can be saved by giving it blood transfusions during the pregnancy.

The standard test to predict whether the fetus needs a blood transfusion is examination of the amniotic fluid. To obtain this fluid a needle has to be inserted in the womb, which has a risk of preterm delivery, infection, and making the disease worse. This is called amniocentesis.

A new safe test, using Doppler ultrasound, has been developed to possibly replace the amniocentesis.

The aim of this study is to compare the new Doppler test with the standard amniocentesis. If the Doppler test is at least as good, this safe test may replace the amniocentesis in the management of pregnancies with Rhesus disease.

Conditions

  • Rh Isoimmunization

Interventions

PROCEDURE

Fetal Middle Cerebral Artery Doppler measurement

Sponsors & Collaborators

  • The Physicians' Services Incorporated Foundation

    collaborator OTHER

  • Stichting Oranjekliniek, The Netherlands

    collaborator UNKNOWN

  • University of Toronto

    lead OTHER

Principal Investigators

  • Dick Oepkes, MD, PhD · Leiden University Medical Centre, The Netherlands

  • Gareth P Seaward, MB, BCh, MSc · Mt.Sinai Hospital, University of Toronto, Canada

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
0 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2000-10-31
Completion
2004-08-31

Countries

  • Canada

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 NCT00295516 on ClinicalTrials.gov