Fetal Middle Cerebral Artery (MCA) Doppler to time second and subsequent transfusions for women with red cell alloimmunisation: A randomised trial

Status

Terminated

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12608000643370

Enrollment

Registered

2008-12-17

Start date

2009-10-19

Completion date

2013-10-01

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The aim of this study is to assess in the fetus where one intrauterine fetal transfusion has been performed for anaemia due to red cell alloimmunisation, whether fetal middle cerebral artery (MCA) Doppler can be safely used to determine the timing of second and subsequent fetal blood transfusions, without increasing the risk of adverse fetal and neonatal health outcomes. Red cell alloimmunisation is estimated to affect 0.1 to 0.6% of all live births. Treatment of the resultant fetal anaemia with intrauterine fetal blood transfusion has been associated with survival rates in excess of 90%. However, intrauterine fetal blood sampling and transfusion is an invasive procedure, with recognised complications, which may result in the need for early birth, and rarely mortality. More recently, reports have emerged utilising Doppler ultrasound to measure the fetal middle cerebral artery (MCA) peak systolic velocity (PSV) to determine the presence of fetal anaemia.

Interventions

Middle Cerebral Artery (MCA) Doppler ultrasound The Middle Cerebral Artery (MCA) Doppler ultrasound will be used to determine the timing of second and subsequent fetal blood transfusions where one intrauterine fetal transfusion has been performed for anaemia due to red cell alloimmunisation. This is an ultrasound examination where the speed of blood flow in the fetal brain is assessed, and is performed during pregnancy. It is used to identify if the fetus is at risk of anaemia. The ultrasound examination takes approximately 10 minutes to perform. Because of the nature of red cell alloimmunisation it is often necessary to perform these ultrasound examinations several times over the course of a pregnancy. Women who participate in the study will be followed to four months after birth.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Diagnosis

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to 48 Years

Healthy volunteers

Inclusion criteria

Pregnant women whose fetus has anaemia secondary to red cell alloimmunisation (due to any red cell antibody alone or in combination) as indicated by the need to have performed a single intra-uterine fetal blood transfusion

Exclusion criteria

Women whose fetus has anaemia secondary to any other cause; known fetal chromosomal anomalies

Outcome results