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

关于

简短的总结

Fetal complete (i.e., 第三个学位, 3°) atrioventricular block (AVB), identified in the 2nd trimester of pregnancy in an otherwise normally developing heart, is almost universally associated with maternal anti-Ro autoantibodies and results in death in a fifth of cases. To date treatment of 3° AVB has been ineffective in restoring normal rhythm (NR) which may be because current surveillance is limited to once- weekly fetal echocardiograms. It is hypothesized that there may be a vital transition period of several hours in which incomplete block (2° AVB) may be successfully treated avoiding fully advanced irreversible 3° AVB. To optimize the likelihood of timely detection of the transition period this study comprises three steps: 1) to risk stratify for high titer anti-Ro antibodies, which are necessary but not sufficient to develop fetal AVB; 2) to empower mothers to identify 2° AVB by using fetal heart rate and rhythm monitoring (FHRM) at home, and 3) to rapidly treat mothers who detect an abnormality by monitoring with an urgent echocardiogram that confirms 2° AVB with the hope of reversing 2° AVB before it becomes permanent (3° AVB). In addition, it will be determined if FHRM reduces the need for weekly echoes. Although mothers with low titer anti-Ro will not be continued in Step 2 and therefore not followed by FHRM, birth ECGs will be collected to confirm that low titer antibodies do not confer risk. It is anticipated that this study will provide an evidenced based surveillance strategy for those mothers at high risk of having a child with 3° AVB.

主要目的
治疗
研究类型
介入
阶段
第三阶段

资格

性别
Healthy Volunteers
No
最低年龄
18年
最高年龄
N/A

Inclusion Criteria:

  • Provision of signed and dated informed consent form
  • Stated willingness to comply with all study procedures and availability for the duration of the study
  • Be <18 weeks pregnant at the time of enrollment
  • Titer of anti-Ro 52 or 60 antibodies ≥1,000 EU
  • Any positive titer of anti-Ro if a history of a previously affected child
  • Ability to take oral medication and be willing to adhere to the dexamethasone and IVIG protocols.
  • Ability to perform Doppler fetal heart rate and rhythm monitoring in the ambulatory setting,
  • Ability to send an audiotext message by cell phone therefore the participant will be informed that they need a phone with texting capabilities. Located within 6 hours drive of the participating pediatric cardiology site
  • Be ≥18 years of age

Exclusion Criteria:

  • Multi-fetal pregnancy
  • Known allergic reactions to components of IVIG, or dexamethasone or maternal IgA deficiency
  • Fetal conduction system disease already present in the current pregnancy
  • Any women who in the opinion of the investigator cannot understand the consent form or be able to perform thrice daily home monitoring or recognize an abnormal fetal heart rate or rhythm
  • 女囚犯
  • 治疗 with >20 mg/prednisone q day or with any dose of fluorinated steroids at enrollment

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分享:
研究统计数据
协议没有.
20-002366
类别
怀孕
联系
玛格丽特·布拉德利
位置
  • 皇冠hga025大学洛杉矶分校韦斯特伍德
为供应商
英国没有.
NCT04474223
For detailed technical eligibility, visit 临床试验.政府.