Gongji Pregnancy Endorine Cohort Study

NCT07125885 | Recruiting

• 1 other identifier: 2022SQ506
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Gestatiaonl Diabetes Mellitus; Thyroid Disease Pregnancy; Hyperglycemia in Pregnant Diabetic Patients

Outcome Measures

Primary Outcomes (3)

• Composite adverse maternal and neonatal outcomes associated with gestational endocrine disorders

  Unit of Measure: Percentage of pregnancies with ≥ 1 event (%) Description: The composite will be coded as Yes/No. An event is counted if any of the following occurs: preeclampsia, cesarean delivery, premature rupture of membranes, placental abruption, preterm birth, congenital malformations, macrosomia, large for gestational age, small for gestational age, neonatal hypoglycemia, neonatal hyperbilirubinemia, neonatal respiratory distress syndrome, neonatal intensive care unit admission, obstetric trauma or still birth. Data abstracted from electronic medical records.

  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

  Percentage of patients with diabetes mellitus (%) Postpartum glucose metabolism will be assessed using an oral glucose tolerance test (OGTT) to determine the incidence of diabetes mellitus. Data will be collected from blood tests and medical records.

  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

  Unit of Measure: Changes in serum thyroid-stimulating hormone (TSH), free triiodothyronine (FT3), and free thyroxine (FT4) levels (mU/L, pg/mL) Postpartum thyroid disease outcomes will be evaluated by measuring serum thyroid-stimulating hormone (TSH), free triiodothyronine (FT3), and free thyroxine (FT4) levels. Changes in these biomarkers will be used to assess thyroid function recovery or progression of thyroid dysfunction (e.g., hypothyroidism or hyperthyroidism) postpartum. These levels will be compared to baseline values, which include both pre-pregnancy and pregnancy-associated measurements. Data will be obtained from blood tests and medical records.

  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 Outcomes (4)

• Incidence of abnormal glucose metabolism in offspring of women with gestational endocrine diseases

  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

  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

  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

  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

• Age: 18 Years - 50 Years
• Sex: female
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

The study will include patients who receive routine prenatal care, delivery, and postpartum endocrinology follow-up at Shanghai General Hospital

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai General Hospital, China: lead

Study Sites (1)

Shanghai General Hospital, China

Shanghai, Shanghai Municipality, 200080, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Stool, Serum/Plasma, Urine, Placenta

Central Study Contacts

Yufan Wang, PhD

CONTACT

(+86) 021-63240090; yyffwang@sina.com

Na Li, PhD

CONTACT

+8613636352801; lena0113@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician, Professor

Study Record Dates

• First Submitted: July 12, 2025
• First Posted: August 15, 2025
• Study Start: May 5, 2023
• Primary Completion (Estimated): December 31, 2043
• Study Completion (Estimated): December 31, 2043
• Last Updated: August 15, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Time Frame: Data will be uploaded to Zenodo and shared, starting 9 months and ending 36 months following article publication

Locations

CN (1)