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STOP BLOQ: (Surveillance and Treatment to Prevent Fetal Atrioventricular Block Likely to Occur Quickly)

Primary Objective

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.

Study category: Pregnancy

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Description

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.

Details
Age

18 to years

Phase

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.

Type of Study

Treatment

Compensation

compensation not provided

Location

Childrens Hospital Colorado

Principal Investigator
Bettina Cuneo

Bettina Cuneo

Resources

Study ID

Protocol Number: 20-1310

More information available at ClinicalTrials.gov: NCT04474223

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