Excessive Iodine StatusNCT03422406
Research on Excessive Iodine Status in Pregnancy
An observational study of Excessive Iodine Status and Thyroid Dysfunction, Antepartum, run by Peking Union Medical College Hospital.
Trial summary
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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Excessive Iodine Status, Thyroid Dysfunction, Antepartum, Pregnancy Related
- What is being tested?
- Dietary iodine intake restriction
- How many people
- 18 participants
- Where
- No sites listed yet
- Study dates
- Jan 2016to Mar 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: 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.
Who may be able to join
- Pregnant women with apparently elevated urinary iodine concentration (UIC ≥250μg/L) and serum iodine concentration (SIC>90μg/L) were enrolled in this study.
Who cannot join
- Subject who did not sign the informed consent or whose clinical date was not intact was excluded in our study.
About this study
Official title: A Prospective Observational Study on Health Effect of Excessive Iodine Exposure in Pregnancy
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.
Read the detailed description
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.
- Conditions
- Excessive Iodine Status, Thyroid Dysfunction, Antepartum, Pregnancy Related, Neonatal Disorder
- Being tested
- Dietary iodine intake restriction
- Keywords
- Iodine excess, Cause, Pregnancy, Urinary iodine concentration, Serum iodine concentration, Breast milk iodine concentration
- Medical subject headings
- Infant, Newborn, Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary iodine intake restrictionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| HH group | Group (participants) with pre-gestational history of undergoing hysterosalpingography (HSG) using an oil-soluble iodinated contrast medium Receives: Other: Dietary iodine intake restriction | |
| Non-HH group | Group (participants) without pre-gestational history of undergoing hysterosalpingography (HSG) Receives: Other: Dietary iodine intake restriction |
What is being measured
The primary outcome is the main question the study is designed to answer.
prevalence of adverse pregnancy outcome
prevalence of stillbirth, abortion and other adverse pregnancy outcome
Measured: 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
Measured: 6-9 months post identification of maternal iodine excess
Secondary outcomes (2)
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.
Measured: 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.
Measured: within 1 week after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2018
- Study startJan 2016
- Primary completionJan 2017
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Excessive Iodine StatusStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xuan Zhang, MD, Study chair, Department of academic research,Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03422406
- Sponsor's protocol ID
- Liuyanping
- Status last verified
- Jan 2018
- First submitted
- 24 Jan 2018
- Last updated
- 6 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sun D, Codling K, Chang S, Zhang S, Shen H, Su X, Chen Z, Scherpbier RW, Yan J. Eliminating Iodine Deficiency in China: Achievements, Challenges and Global Implications. Nutrients. 2017 Apr 5;9(4):361. doi: 10.3390/nu9040361.
PubMed 28379180Alexander EK, Pearce EN, Brent GA, Brown RS, Chen H, Dosiou C, Grobman WA, Laurberg P, Lazarus JH, Mandel SJ, Peeters RP, Sullivan S. 2017 Guidelines of the American Thyroid Association for the Diagnosis and Management of Thyroid Disease During Pregnancy and the Postpartum. Thyroid. 2017 Mar;27(3):315-389. doi: 10.1089/thy.2016.0457.
PubMed 28056690Xiao Y, Sun H, Li C, Li Y, Peng S, Fan C, Teng W, Shan Z. Effect of Iodine Nutrition on Pregnancy Outcomes in an Iodine-Sufficient Area in China. Biol Trace Elem Res. 2018 Apr;182(2):231-237. doi: 10.1007/s12011-017-1101-4. Epub 2017 Aug 2.
PubMed 28770411So S, Yamaguchi W, Tajima H, Nakayama T, Tamura N, Kanayama N, Tawara F. The effect of oil and water-soluble contrast medium in hysterosalpingography on thyroid function. Gynecol Endocrinol. 2017 Sep;33(9):682-685. doi: 10.1080/09513590.2017.1307960. Epub 2017 Apr 17.
PubMed 28412871Kaneshige T, Arata N, Harada S, Ohashi T, Sato S, Umehara N, Saito T, Saito H, Murashima A, Sago H. Changes in serum iodine concentration, urinary iodine excretion and thyroid function after hysterosalpingography using an oil-soluble iodinated contrast medium (lipiodol). J Clin Endocrinol Metab. 2015 Mar;100(3):E469-72. doi: 10.1210/jc.2014-2731. Epub 2014 Dec 29.
PubMed 25546154Satoh M, Aso K, Katagiri Y. Thyroid Dysfunction in Neonates Born to Mothers Who Have Undergone Hysterosalpingography Involving an Oil-Soluble Iodinated Contrast Medium. Horm Res Paediatr. 2015;84(6):370-5. doi: 10.1159/000439381. Epub 2015 Sep 25.
PubMed 26402613Mekaru K, Kamiyama S, Masamoto H, Sakumoto K, Aoki Y. Thyroid function after hysterosalpingography using an oil-soluble iodinated contrast medium. Gynecol Endocrinol. 2008 Sep;24(9):498-501. doi: 10.1080/09513590802246364.
PubMed 18958768Omoto A, Kurimoto C, Minagawa M, Shozu M. A case of fetal goiter that resolved spontaneously after birth. J Clin Endocrinol Metab. 2013 Oct;98(10):3910-1. doi: 10.1210/jc.2013-1066. Epub 2013 Aug 26. No abstract available.
PubMed 23979952
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Observational Study on Health Effect of Excessive Iodine Exposure in Pregnancy
- ClinicalTrials.gov ID
- NCT03422406
- Acronym / sponsor ID
- Liuyanping
- Conditions
- Excessive Iodine Status, Thyroid Dysfunction, Antepartum, Pregnancy Related, Neonatal Disorder
- Keywords
- Iodine excess, Cause, Pregnancy, Urinary iodine concentration, Serum iodine concentration, Breast milk iodine concentration
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- Jan 2016 (actual)
- Primary completion
- Jan 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 5 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HH group | – | Other: Dietary iodine intake restrictionGroup (participants) with pre-gestational history of undergoing hysterosalpingography (HSG) using an oil-soluble iodinated contrast medium |
| Non-HH group | – | Other: Dietary iodine intake restrictionGroup (participants) without pre-gestational history of undergoing hysterosalpingography (HSG) |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 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.
Key inclusion criteria (1 listed)
- Pregnant women with apparently elevated urinary iodine concentration (UIC ≥250μg/L) and serum iodine concentration (SIC>90μg/L) were enrolled in this study.
Key exclusion criteria (1 listed)
- Subject who did not sign the informed consent or whose clinical date was not intact was excluded in our study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dietary iodine intake restrictionAll 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. | Other | HH group, Non-HH group |
Primary outcome
prevalence of adverse pregnancy outcome
Time frame: 6-9 months post identification of maternal iodine excess
prevalence of stillbirth, abortion and other adverse pregnancy outcome
composite neonatal outcome
Time frame: 6-9 months post identification of maternal iodine excess
Apgar scores, birth weight of the neonates,and prevalence of thyroid dysfunction in neonates
2 secondary outcomes
prevalence of maternal thyroid dysfunction in pregnancy
Time frame: through study completion, about 6-9 months post identification of maternal iodine excess
prevalence of neonatal iodine excess
Time frame: within 1 week after birth
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2018.
- Results publication: PubMed 28379180Sun D, Codling K, Chang S, Zhang S, Shen H, Su X, Chen Z, Scherpbier RW, Yan J. Eliminating Iodine Deficiency in China: Achievements, Challenges and Global Implications. Nutrients. 2017 Apr 5;9(4):361. doi: 10.3390/nu9040361.
- Results publication: PubMed 28056690Alexander EK, Pearce EN, Brent GA, Brown RS, Chen H, Dosiou C, Grobman WA, Laurberg P, Lazarus JH, Mandel SJ, Peeters RP, Sullivan S. 2017 Guidelines of the American Thyroid Association for the Diagnosis and Management of Thyroid Disease During Pregnancy and the Postpartum. Thyroid. 2017 Mar;27(3):315-389. doi: 10.1089/thy.2016.0457.
- Results publication: PubMed 28770411Xiao Y, Sun H, Li C, Li Y, Peng S, Fan C, Teng W, Shan Z. Effect of Iodine Nutrition on Pregnancy Outcomes in an Iodine-Sufficient Area in China. Biol Trace Elem Res. 2018 Apr;182(2):231-237. doi: 10.1007/s12011-017-1101-4. Epub 2017 Aug 2.
- Results publication: PubMed 28412871So S, Yamaguchi W, Tajima H, Nakayama T, Tamura N, Kanayama N, Tawara F. The effect of oil and water-soluble contrast medium in hysterosalpingography on thyroid function. Gynecol Endocrinol. 2017 Sep;33(9):682-685. doi: 10.1080/09513590.2017.1307960. Epub 2017 Apr 17.
- Results publication: PubMed 25546154Kaneshige T, Arata N, Harada S, Ohashi T, Sato S, Umehara N, Saito T, Saito H, Murashima A, Sago H. Changes in serum iodine concentration, urinary iodine excretion and thyroid function after hysterosalpingography using an oil-soluble iodinated contrast medium (lipiodol). J Clin Endocrinol Metab. 2015 Mar;100(3):E469-72. doi: 10.1210/jc.2014-2731. Epub 2014 Dec 29.
- Results publication: PubMed 26402613Satoh M, Aso K, Katagiri Y. Thyroid Dysfunction in Neonates Born to Mothers Who Have Undergone Hysterosalpingography Involving an Oil-Soluble Iodinated Contrast Medium. Horm Res Paediatr. 2015;84(6):370-5. doi: 10.1159/000439381. Epub 2015 Sep 25.
- Results publication: PubMed 18958768Mekaru K, Kamiyama S, Masamoto H, Sakumoto K, Aoki Y. Thyroid function after hysterosalpingography using an oil-soluble iodinated contrast medium. Gynecol Endocrinol. 2008 Sep;24(9):498-501. doi: 10.1080/09513590802246364.
- Results publication: PubMed 23979952Omoto A, Kurimoto C, Minagawa M, Shozu M. A case of fetal goiter that resolved spontaneously after birth. J Clin Endocrinol Metab. 2013 Oct;98(10):3910-1. doi: 10.1210/jc.2013-1066. Epub 2013 Aug 26. No abstract available.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xuan Zhang, MD study chair
Department of academic research,Peking Union Medical College Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Excessive Iodine Status and Thyroid Dysfunction, Antepartum, run by Peking Union Medical College Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
prevalence of adverse pregnancy outcome (time frame: 6-9 months post identification of maternal iodine excess). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03422406, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2018.