Weight Gain Recommendations for Chinese Women With Gestational Diabetes Mellitus

Gestational Weight Gain (GWG) Recommendations for Chinese Women With Gestational Diabetes Mellitus (GDM)

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.

Study Overview

• Status: Recruiting
• Conditions: Gestational Diabetes; Gestational Weight Gain
• Intervention / Treatment: Behavioral: prenatal care for women with GDM

Detailed Description

This project is a prospective cohort study designed to investigated the changes in blood glucose and body weight in women with gestational diabetes during pregnancy. The study aimed to enroll 4000 participants, using health management app in addition to routine prenatal care. Researchers screen subjects strictly according to the exclusion and inclusion criteria and those who interested sign the informed consent. participants completed baseline questionnaire and dietary questionnaire at app under the instruction of researchers. Pregnant women come back for follow up-visit every 2 weeks until delivery. If anyone doesn't upload the weight data for a week and doesn't respond to the phone call from the researchers, she will be regarded as lost follow-up,the number of lost follow-up cases are supplemented by increasing the enrollment. Data analysis and result output finally.

Besides, part of the study conducted in Beijing has some special points which don't exsit in large cohort study: participants equipment dynamic blood glucose monitor for glycemic control and their blood samples and stool samples will be collected at 24-28, 32 and 36 gestational weeks,respectively.

Based on the description of weight gain range of pregnant women with normal blood glucose, the influence of weight gain on adverse pregnancy outcome was analyzed, and the recommended weight gain value for women with gestational diabetes was proposed in combination with Delphi expert consultation method.

• Study Type: Observational
• Enrollment (Anticipated): 4050

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100730
      • Recruiting
      • Department of ob gyn, Peking Union Medical College Hospital
      • Contact: Liangkun Ma, MD; Phone Number: +8613021961166; Email: MaLiangKun@pumch.cn
      • Contact: Ying Tian; Phone Number: 15110790115; Email: 1220325578@qq.com

Participation Criteria

Eligibility Criteria

• 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

pregnancies with gestational diabetes mellitus

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; we conduct prenatal care for GDM pregnancies through both prenatal clinic and app.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
the value of gestational weight gain during third trimester	pregnant women with diabetes mellitus type 2,children with hypertension,obesity,diabetes,cardiovascular disease,etc.	from enrollment to delivery

Collaborators and Investigators

• Sponsor: Peking Union Medical College Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 24, 2020
• Primary Completion (ANTICIPATED): December 30, 2021
• Study Completion (ANTICIPATED): June 30, 2022

Study Registration Dates

• First Submitted: June 5, 2020
• First Submitted That Met QC Criteria: June 5, 2020
• First Posted (ACTUAL): June 9, 2020

Study Record Updates

• Last Update Posted (ACTUAL): October 21, 2021
• Last Update Submitted That Met QC Criteria: October 19, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: gestational diabetes mellitus; gestational weight gain; blood glucoes monitoring; health management; moblie health
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Pregnancy Complications; Body Weight Changes; Diabetes Mellitus; Body Weight; Weight Gain; Diabetes, Gestational; Gestational Weight Gain
• Other Study ID Numbers: JS-2333

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No