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Registry Study for Pregnant Women With Iodine Overload

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03470597
Recruitment Status : Unknown
Verified March 2018 by Rongrong Li, Peking Union Medical College Hospital.
Recruitment status was:  Not yet recruiting
First Posted : March 20, 2018
Last Update Posted : March 20, 2018
Sponsor:
Information provided by (Responsible Party):
Rongrong Li, Peking Union Medical College Hospital

Study Description
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Brief Summary:
Pre-gestational performance of hysterosalpingography (HSG) using an oil-soluble iodinated contrast medium has been demonstrated to be the main cause of excessive iodine exposure for pregnant women. However, its long-term health effects on the mothers and offsprings have not been adequately elucidated. A case registry study is designed to follow up all the pregnant women with pre-gestational history of ethiodized-oil HSG examination and try to keep track of maternal and fetal outcomes.

Condition or disease Intervention/treatment
Iodine Overload in Pregnancy Other: dietary iodine restriction on subjects with iodine overload

Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 195 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
Official Title: Registry Study on Effect of Excessive Iodine Exposure on Maternal and Fetal Outcomes
Estimated Study Start Date : April 1, 2018
Estimated Primary Completion Date : March 1, 2020
Estimated Study Completion Date : June 1, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Iodine

Groups and Cohorts
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Group/Cohort Intervention/treatment
Pregnant women with pre-gestational HSG history
All enrolled pregnant women with pre-gestational ethiodized-oil HSG will be followed up without grouping and be kept track for maternal and offspring's health outcomes in this case registry study.
 Other: dietary iodine restriction on subjects with iodine overload
In this case registry study (observational study),all intervention will be performed not for research purposes, but only part of routine treatment, which will be recorded in database of the registry study.


Outcome Measures
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Primary Outcome Measures :
  1. comprehensive pregnant outcomes_prevalence of gestational diabetes [ Time Frame: during the whole pregnancy, from date of verification of pregnancy until the date of termination of pregnancy, assessed up to 10 months ]
    prevalence of gestational diabetes

  2. comprehensive pregnant outcomes_prevalence of gestational hypertension [ Time Frame: during the whole pregnancy, from date of verification of pregnancy until the date of termination of pregnancy, assessed up to 10 months ]
    prevalence of gestational hypertension

  3. comprehensive pregnant outcomes_prevalence of abnormal pregnancy [ Time Frame: during the whole pregnancy, from date of verification of pregnancy until the date of termination of pregnancy, assessed up to 10 months ]
    prevalence of abnormal pregnancy (stillbirth, abortion, premature delivery)

  4. comprehensive pregnant outcomes_rate of cesarean section [ Time Frame: at the time of delivery ]
    rate of cesarean section

  5. comprehensive neonatal outcomes at delivery [ Time Frame: at the time of delivery ]
    Apgar scores of neonates

  6. comprehensive neonatal outcomes_neonatal weight [ Time Frame: at the time of delivery ]
    birth weight of neonates

  7. comprehensive neonatal outcomes_neonatal head circumference [ Time Frame: at the time of delivery ]
    head circumference of neonates

  8. comprehensive neonatal outcomes_neonatal height [ Time Frame: at the time of delivery ]
    height of neonates

  9. comprehensive neonatal outcomes_neonatal BMI [ Time Frame: at the time of delivery ]
    BMI of neonates

  10. comprehensive neonatal outcomes_prevalence of macrosomia or underweight [ Time Frame: at the time of delivery ]
    prevalence of macrosomia or underweight

  11. offspring outcomes_prevalence of thyroid dysfunction [ Time Frame: from birth to age of 1 year old, assessed every 6 months ]
    prevalence of thyroid dysfunction (hyperthyroidism or hypothyroidism)

  12. offspring outcomes_neurodevelopment evaluation in long term [ Time Frame: from birth to age of 1 year old, assessed every 6 months ]
    Norwegian version of the Ages and Stages Questionnaire (ASQ) scores for evaluation of infant neurodevelopment

  13. comprehensive offspring outcomes in long term - weight evaluation [ Time Frame: from birth to age of 1 year old, assessed every 3-6 months ]
    weight of offsprings

  14. comprehensive offspring outcomes in long term - height evaluation [ Time Frame: from birth to age of 1 year old, assessed every 3-6 months ]
    height of offsprings

  15. comprehensive offspring outcomes in long term - BMI evaluation [ Time Frame: from birth to age of 1 year old, assessed every 3-6 months ]
    BMI of offsprings


Secondary Outcome Measures :
  1. prevalence of thyroid dysfunction in pregnancy [ Time Frame: during the whole pregnancy, from date of verification of pregnancy until the date of termination of pregnancy, assessed up to 10 months ]
    evaluation of maternal TSH, T3, T4, FT3, FT4, TRAb,Tg-Ab, TPO-Ab

  2. prevalence of iodine overload in neonates [ Time Frame: within 1 week after birth of neonates ]
    prevalence of infants with urinary iodine concentration ≥200μg/L


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Pregnant women with excessive iodine exposure caused by pre-gestational ethiodized-oil HSG
Criteria

Inclusion Criteria:

Must be pregnant when enrolled in this study. Must have undergone examination of ethiodized-oil HSG before this pregnancy. Clinical diagnosis of iodine excess (with the mean urine iodine concentration ≥250μg/L and the serum iodine concentration >92μg/L).

Exclusion Criteria:

Having past history of partial or total resection of thyroid glands. Having medical history of thyroid dysfunction before ethiodized-oil HSG examination.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03470597


Contacts
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Contact: Rongrong Li +861069159088 lirongrong0331@163.com

Sponsors and Collaborators
Peking Union Medical College Hospital
More Information
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Additional Information:

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Responsible Party: Rongrong Li, nutrition physician, Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT03470597    
Other Study ID Numbers: Liuyanping2
First Posted: March 20, 2018    Key Record Dates
Last Update Posted: March 20, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Iodine
Anti-Infective Agents, Local
Anti-Infective Agents
 Trace Elements
Micronutrients
Physiological Effects of Drugs