Weight Gain Recommendations for Chinese Women With Gestational Diabetes Mellitus

NCT04421053 | Unknown

• 1 other identifier: JS-2333
• Study Type: observational
• Target: 4,050
• Locations: 1 country
• Sites: 1

Brief Summary

The 2009 IOM recommendation value for weight gain during pregnancy is widely used. Due to the unclear relationship between gestational diabetes mellitus and weight gain during pregnancy when formulating this recommendation value, pregnant women with gestational diabetes mellitus were excluded from the study population. Control of appropriate weight gain and control of blood glucose stability is an important part of GDM management in pregnant women. The incidence of GDM in China is about 15%-20%, and the number of pregnant women with GDM ranks first in the world. For the sake of the current and long-term health of maternal and infant, it is of great significance to explore the appropriate weight gain range and formulate the recommended value for GDM pregnant women as an independent population. This project intends to use prospective cohort study of combining the observation of pregnant women with gestational diabetes blood sugar and weight changes, through the comparison of normal pregnant women suitable scope of weight gain, analyzes its influence on adverse pregnancy outcomes, increased the weight of gestational diabetes women recommended value is put forward, and combined with the Delphi expert consultation method for evaluation.

Conditions

Gestational Diabetes; Gestational Weight Gain

Keywords

gestational diabetes mellitus; gestational weight gain; blood glucoes monitoring; health management; moblie health

Outcome Measures

Primary Outcomes (2)

• The incidence rate of pregnancy outcomes

  pregnancy outcomes including preeclampsia, gestational hypertension.

  delivery

• The incidence rate of infant outcomes

  infant outcomes including SGA,neonatal hypoglycemia.

  delivery

Secondary Outcomes (1)

• the value of gestational weight gain during third trimester

  from enrollment to delivery

Study Arms (1)

women with GDM

After participants enrollment, we conducted follow-up visit every two weeks. Blood glucose values, body weight, life style record and clinical information are collected. Blood samples and stool samples are collected from participants in Beijing.

Behavioral: prenatal care for women with GDM

Interventions

prenatal care for women with GDM BEHAVIORAL

we conduct prenatal care for GDM pregnancies through both prenatal clinic and app.

women with GDM

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

pregnancies with gestational diabetes mellitus

You may qualify if:

• Pregnant women who have regular labor inspection and delivery in the labor inspection hospital;
• Pregnant women with gestational diabetes diagnosed by OGTT at 24 to 28 weeks of pregnancy;
• Singleton pregnancy;
• Those who can skillfully use mobile phones and other electronic devices for scientific follow-up and voluntarily record their daily weight;
• Voluntary signing of informed consent.

You may not qualify if:

• Patients with pre-pregnancy diabetes mellitus or abnormal OGTT screening in early pregnancy;
• diabetic ketoacidosis,high blood sugar of high permeability anemia,leukemia, and lymphoma without clinical control.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Department of ob gyn, Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood samples and stool samples are collected from participants in Beijing.

MeSH Terms

Conditions

Diabetes, Gestational; Gestational Weight Gain

Interventions

Prenatal Care

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Weight Gain; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Maternal Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Liangkun Ma

  Chinese Academy of Medical Science & Peking Union Medical College Hospital

  STUDY CHAIR

Central Study Contacts

Liangkun Ma

CONTACT

13021961166; MaLiangKun@pumch.cn

Ying Tian

CONTACT

13121591988; 1220325578@qq.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2020
• First Posted: June 9, 2020
• Study Start: March 24, 2020
• Primary Completion: December 30, 2021
• Study Completion: June 30, 2022
• Last Updated: October 21, 2021

Record last verified: 2021-05

Locations

CN (1)