Recruiting NCT07125885
Gongji Pregnancy Endorine Cohort Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Gestatiaonl Diabetes Mellitus, Thyroid Disease Pregnancy, Hyperglycemia in Pregnant Diabetic Patients. Basic parameters: 18 years — 50 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Serological, Metabolomic, and Genomic Studies of Endocrine Disorders in Pregnancy
Overview
To explore the relationship between genetic factors, lifestyle, and drug interventions and the occurrence, development, adverse pregnancy outcomes, and postpartum maternal-infant outcomes of gestational endocrine diseases.
Detailed description
Time Perspective: Prospective and retrospective
Primary outcome measures
- Composite adverse maternal and neonatal outcomes associated with gestational endocrine disorders [Time frame: From delivery (Day 0) through the initial birth hospitalization, assessed up to 14 days postpartum.]
- Postpartum glucose metabolism outcomes in patients with endocrine disorders in pregnancy [Time frame: From 6 weeks postpartum through long-term follow-up, with assessments at 6 weeks and every 12 months thereafter, for ≥3 years and up to 40 years postpartum.]
- Postpartum thyroid disease outcomes in patients with endocrine disorders in pregnancy [Time frame: From 6 weeks postpartum through long-term follow-up, with assessments at 6 weeks and every 12 months thereafter, for ≥3 years and up to 40 years postpartum.]
Secondary outcome measures (4)
- Incidence of abnormal glucose metabolism in offspring of women with gestational endocrine diseases [Time frame: From 6 weeks postpartum through long-term follow-up, with assessments at 6 weeks and every 12 months thereafter, for ≥3 years and up to 40 years postpartum.]
- Incidence of thyroid disorders in offspring of women with gestational endocrine diseases [Time frame: From 6 weeks postpartum through long-term follow-up, with assessments at 6 weeks and every 12 months thereafter, for ≥3 years and up to 40 years postpartum.]
- Growth Abnormalities in Offspring of Women with Gestational Endocrine Diseases [Time frame: From 6 weeks postpartum through long-term follow-up, with assessments at 6 weeks and every 12 months thereafter, for ≥3 years and up to 40 years postpartum.]
- Developmental abnormalities in offspring of women with gestational endocrine diseases [Time frame: From 6 weeks postpartum through long-term follow-up, with assessments at 6 weeks and every 12 months thereafter, for ≥3 years and up to 40 years postpartum.]
Eligibility criteria
Inclusion criteria
- Women preparing for pregnancy or pregnant women or within 1 year after giving birth
- Age ≥ 18 years old
- Signed the informed consent form to voluntarily enroll in the management follow-up
Exclusion criteria
- Individuals who are unable to communicate normally and those who are unwilling to cooperate
- Pregnant women with severe organic diseases or mental illnesses
- Any condition deemed by the investigator to affect eligibility for the study
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Shanghai General Hospital, China — Shanghai
Identifiers
NCT: NCT07125885 · 2022SQ506