Registry Study for Pregnant Women With Iodine Overload

March 18, 2018 updated by: Rongrong Li, Peking Union Medical College Hospital

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
195

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Pregnant women with excessive iodine exposure caused by pre-gestational ethiodized-oil HSG

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
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
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
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
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)
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
Time Frame: at the time of delivery
rate of cesarean section
at the time of delivery
comprehensive neonatal outcomes at delivery
Time Frame: at the time of delivery
Apgar scores of neonates
at the time of delivery
comprehensive neonatal outcomes_neonatal weight
Time Frame: at the time of delivery
birth weight of neonates
at the time of delivery
comprehensive neonatal outcomes_neonatal head circumference
Time Frame: at the time of delivery
head circumference of neonates
at the time of delivery
comprehensive neonatal outcomes_neonatal height
Time Frame: at the time of delivery
height of neonates
at the time of delivery
comprehensive neonatal outcomes_neonatal BMI
Time Frame: at the time of delivery
BMI of neonates
at the time of delivery
comprehensive neonatal outcomes_prevalence of macrosomia or underweight
Time Frame: at the time of delivery
prevalence of macrosomia or underweight
at the time of delivery
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)
from birth to age of 1 year old, assessed every 6 months
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
from birth to age of 1 year old, assessed every 6 months
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
from birth to age of 1 year old, assessed every 3-6 months
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
from birth to age of 1 year old, assessed every 3-6 months
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
from birth to age of 1 year old, assessed every 3-6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
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
prevalence of infants with urinary iodine concentration ≥200μg/L
within 1 week after birth of neonates

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Peking Union Medical College Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2018

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2020

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 6, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 18, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 20, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 20, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 18, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Liuyanping2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Iodine Overload in Pregnancy

Clinical Trials on dietary iodine restriction on subjects with iodine overload

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings