This study has three purposes. The first is to find out if you have a high level of these anti-Ro/SSA antibodies in your blood which puts you at greater risk of having a baby with a heart problem. The second purpose is to find out if listening to your fetus’s heartbeat using a small Doppler device 3x/day at your home, can identify an abnormal fetal heartbeat (a slow heart rate or an irregular heart rhythm). The third purpose is to find out if urgent treatment of an abnormal fetal heartbeat can restore normal rhythm, if this abnormal heart- beat is found to be 2° heart block.
While in this study you will be asked You will be asked to participate (if eligible) in three STEPS:
STEP 1 – a screening step to evaluate the level of antibodies to Ro52 and Ro60 (proteins in your blood);
STEP 2 – This step occurs if you are found to have high amounts of anti-Ro60 or Ro52 antibodies and involves every-other-week echos and listening to your baby’s heart beat 3x/day.
The listening to the heart is called Fetal Heart Rate Monitoring (FHRM);
STEP 3 – a treatment step consisting of dexamethasone and IVIG if heart block develops.
Main Procedures Involved: - Blood draw (to evaluate anti-Ro/SSA levels) - Fetal Heart Rate Monitoring (at-home, using a commercially available doppler) - Fetal echocardiogram - Infant ECG
Duration of Participation: This study will last up to 2 years and will involve about 10 visits.
18 to years
III - Research Studies that gather more information about a drug's safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. These studies typically involve more participants.
compensation not provided
Childrens Hospital Colorado
Protocol Number: 20-1310
More information available at ClinicalTrials.gov: NCT04474223
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