Iodine Overload in PregnancyNCT03470597
Registry Study for Pregnant Women With Iodine Overload
An observational study of Iodine Overload in Pregnancy, run by Peking Union Medical College Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Iodine Overload in Pregnancy
- What is being tested?
- dietary iodine restriction on subjects with iodine overload
- How many people
- 195 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2018to 1 Jun 2020
- How long will I take part?
- 2 Years
- 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 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Study population: Pregnant women with excessive iodine exposure caused by pre-gestational ethiodized-oil HSG
Who may be able to join
- 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).
Who cannot join
- Having past history of partial or total resection of thyroid glands. Having medical history of thyroid dysfunction before ethiodized-oil HSG examination.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Registry Study on Effect of Excessive Iodine Exposure on Maternal and Fetal Outcomes
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.
- Conditions
- Iodine Overload in Pregnancy
- Being tested
- dietary iodine restriction on subjects with iodine overload
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dietary iodine restriction on subjects with iodine overloadOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: dietary iodine restriction on subjects with iodine overload |
What is being measured
The primary outcome is the main question the study is designed to answer.
comprehensive pregnant outcomes_prevalence of gestational diabetes
prevalence of gestational diabetes
Measured: during the whole pregnancy, from date of verification of pregnancy until the date of termination of pregnancy, assessed up to 10 months
comprehensive pregnant outcomes_prevalence of gestational hypertension
prevalence of gestational hypertension
Measured: during the whole pregnancy, from date of verification of pregnancy until the date of termination of pregnancy, assessed up to 10 months
comprehensive pregnant outcomes_prevalence of abnormal pregnancy
prevalence of abnormal pregnancy (stillbirth, abortion, premature delivery)
Measured: during the whole pregnancy, from date of verification of pregnancy until the date of termination of pregnancy, assessed up to 10 months
comprehensive pregnant outcomes_rate of cesarean section
rate of cesarean section
Measured: at the time of delivery
comprehensive neonatal outcomes at delivery
Apgar scores of neonates
Measured: at the time of delivery
comprehensive neonatal outcomes_neonatal weight
birth weight of neonates
Measured: at the time of delivery
comprehensive neonatal outcomes_neonatal head circumference
head circumference of neonates
Measured: at the time of delivery
comprehensive neonatal outcomes_neonatal height
height of neonates
Measured: at the time of delivery
comprehensive neonatal outcomes_neonatal BMI
BMI of neonates
Measured: at the time of delivery
comprehensive neonatal outcomes_prevalence of macrosomia or underweight
prevalence of macrosomia or underweight
Measured: at the time of delivery
offspring outcomes_prevalence of thyroid dysfunction
prevalence of thyroid dysfunction (hyperthyroidism or hypothyroidism)
Measured: from birth to age of 1 year old, assessed every 6 months
offspring outcomes_neurodevelopment evaluation in long term
Norwegian version of the Ages and Stages Questionnaire (ASQ) scores for evaluation of infant neurodevelopment
Measured: from birth to age of 1 year old, assessed every 6 months
comprehensive offspring outcomes in long term - weight evaluation
weight of offsprings
Measured: from birth to age of 1 year old, assessed every 3-6 months
comprehensive offspring outcomes in long term - height evaluation
height of offsprings
Measured: from birth to age of 1 year old, assessed every 3-6 months
comprehensive offspring outcomes in long term - BMI evaluation
BMI of offsprings
Measured: from birth to age of 1 year old, assessed every 3-6 months
Secondary outcomes (2)
prevalence of thyroid dysfunction in pregnancy
evaluation of maternal TSH, T3, T4, FT3, FT4, TRAb,Tg-Ab, TPO-Ab
Measured: during the whole pregnancy, from date of verification of pregnancy until the date of termination of pregnancy, assessed up to 10 months
prevalence of iodine overload in neonates
prevalence of infants with urinary iodine concentration ≥200μg/L
Measured: within 1 week after birth of neonates
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2018
- Study start1 Apr 2018 (estimated)
- Primary completion1 Mar 2020 (estimated)
- Study completion1 Jun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Iodine Overload in PregnancyStudies 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
- 195 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rongrong Li, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03470597
- Sponsor's protocol ID
- Liuyanping2
- Status last verified
- Mar 2018
- First submitted
- 6 Feb 2018
- Last updated
- 20 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Registry Study on Effect of Excessive Iodine Exposure on Maternal and Fetal Outcomes
- ClinicalTrials.gov ID
- NCT03470597
- Acronym / sponsor ID
- Liuyanping2
- Conditions
- Iodine Overload in Pregnancy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 195 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 1 Apr 2018 (estimated)
- Primary completion
- 1 Mar 2020 (estimated)
- Study completion
- 1 Jun 2020 (estimated)
- First posted
- 20 Mar 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.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pregnant women with pre-gestational HSG history | – | Other: dietary iodine restriction on subjects with iodine overloadAll 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Pregnant women with excessive iodine exposure caused by pre-gestational ethiodized-oil HSG
Key inclusion criteria (1 listed)
- 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).
Key exclusion criteria (1 listed)
- Having past history of partial or total resection of thyroid glands. Having medical history of thyroid dysfunction before ethiodized-oil HSG examination.
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 restriction on subjects with iodine overloadIn 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. | Other | Pregnant women with pre-gestational HSG history |
Primary outcome
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
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
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)
comprehensive pregnant outcomes_rate of cesarean section
Time frame: at the time of delivery
rate of cesarean section
comprehensive neonatal outcomes at delivery
Time frame: at the time of delivery
Apgar scores of neonates
comprehensive neonatal outcomes_neonatal weight
Time frame: at the time of delivery
birth weight of neonates
comprehensive neonatal outcomes_neonatal head circumference
Time frame: at the time of delivery
head circumference of neonates
comprehensive neonatal outcomes_neonatal height
Time frame: at the time of delivery
height of neonates
comprehensive neonatal outcomes_neonatal BMI
Time frame: at the time of delivery
BMI of neonates
comprehensive neonatal outcomes_prevalence of macrosomia or underweight
Time frame: at the time of delivery
prevalence of macrosomia or underweight
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)
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
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
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
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
2 secondary outcomes
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
prevalence of iodine overload in neonates
Time frame: within 1 week after birth of neonates
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2018.
- 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.
Questions about this trial
What is this clinical trial studying?
An observational study of Iodine Overload in Pregnancy, 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: status not confirmed, as of the sponsor's last update on 20 Mar 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rongrong Li (+861069159088, lirongrong0331@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Mar 2018.