An observational study in Excessive Iodine Status, Thyroid Dysfunction, Antepartum and Pregnancy Related, sponsored by Peking Union Medical College Hospital. Completed. Open to female participants. Per ClinicalTrials.gov, last updated 2018-02-06.
Sponsored by Peking Union Medical College Hospital · Observational
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To explore main cause and health impact of iodine excess during pregnancy, we performed iodine evaluation for 390 consecutive pregnant women from January 1st, 2016 to December 31st, 2016. Among them, 18 women (4.62%) with apparently elevated urinary iodine concentration (UIC) were enrolled onto this study for subsequent follow-up. History of high iodine exposure was collected from all participants. Parameters about iodine status were monitors until termination of pregnancy, and dietary iodine intake condition and thyroid function were also evaluated.
A prospective follow-up was arranged for the 18 pregnant women with excessive iodine status. History of iodine exposure (including hysterosalpingography (HSG) using an oil-soluble iodinated contrast medium, examination by computed tomography scan with contrast, administration of amiodarone, history of receiving radioiodine therapy, etc.) was collected from all participants. Evaluation of dietary iodine intake was performed through a 72-hour dietary recall.The serum iodine concentration (SIC) and urinary iodine concentration (UIC) were monitored continuously in the whole course of pregnancy. All subjects with excessive iodine load were recommended by nutritionists to have their dietary iodine intake restricted, and resume iodine-containing supplements and foods until the UIC\<250 μg/L and SIC≤90 μg/L. After delivery, maternal colostrum iodine concentration and neonatal iodine status (including neonatal UIC, condition of congenital hypothyroidism screening tests, and thyroid physical examination) were also assessed.
140 studies on the registry are indexed under Infant, Newborn, Diseases; 29 are open to participants now.
This study's enrollment of 18 is below the median of 100 across 49 observational studies indexed under Infant, Newborn, Diseases.
Browse Infant, Newborn, Diseases studies →Peking Union Medical College Hospital is the lead sponsor of 1,155 studies on the registry; 475 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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All enrolled pregnant women will be from urban area of Beijing, whose dietary iodine intake and pre-gestational history of iodine exposure will be reviewd in detail.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Group (participants) with pre-gestational history of undergoing hysterosalpingography (HSG) using an oil-soluble iodinated contrast medium
Other: Dietary iodine intake restriction
Group (participants) without pre-gestational history of undergoing hysterosalpingography (HSG)
Other: Dietary iodine intake restriction
All subjects with excessive iodine load were recommended by nutritionists to restrict dietary iodine intake, and resume iodine-containing supplements and foods until their iodine status return to normal. However, in this observational study, the intervention was a regular management in prenatal care, and not assigned by investigator of the study.
prevalence of adverse pregnancy outcome
prevalence of stillbirth, abortion and other adverse pregnancy outcome
Time frame: 6-9 months post identification of maternal iodine excess
composite neonatal outcome
Apgar scores, birth weight of the neonates,and prevalence of thyroid dysfunction in neonates
Time frame: 6-9 months post identification of maternal iodine excess
prevalence of maternal thyroid dysfunction in pregnancy
Laboratory reference ranges of TSH during pregnancy were 0.1\~2.5 mIU/L for the first trimester, 0.2\~3.0 mIU/L for the second trimester and 0.3\~3.0 mIU/L for the third trimester.Prevalence of TSH elevation during pregnancy will be summarized.
Time frame: through study completion, about 6-9 months post identification of maternal iodine excess
prevalence of neonatal iodine excess
urinary iodine concentration will be examined for all neonates born to women with iodine excess in pregnancy, and prevalence of neonatal urinary iodine concentration ≥ 200μg/L will be summarized.
Time frame: within 1 week after birth
No study locations are listed for this record.
Plan to share: No
Ran from Jan 2016 to primary completion in Jan 2017, 12 months.
Of 32 observational studies under Infant, Newborn, Diseases, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 39. This study's 12 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.
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