Registry Study for Pregnant Women With Iodine Overload

NCT ID: NCT03470597

Last Updated: 2018-03-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

195 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-04-01

Study Completion Date

2020-06-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Iodine Overload in Pregnancy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

dietary iodine restriction on subjects with iodine overload

Intervention Type OTHER

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Peking Union Medical College Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Rongrong Li

nutrition physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Rongrong Li

Role: CONTACT

+861069159088

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Liuyanping2

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Preventing Lack of Iodine During Pregnancy
NCT00379535 TERMINATED PHASE3