A Prospective Randomized Controlled Trial of Mobile Medical Used for Management of Pregnant Women

Chinese Academy of Medical Sciences & Peking Union Medical College

Status

Completed

Conditions

Blood Glucose

Mobile Health

GDM

Diet Habit

Maternal Behavior

Pregnancy Outcome

Compliance, Patient

Treatments

Behavioral: telemedicine: management through WeChat group chat

Study type

Interventional

Funder types

Other

Identifiers

NCT03748576

JS-1012

Details and patient eligibility

About

A multicenter, randomized controlled trial was conducted to investigate whether health education and life style management through WeChat group chat was: 1. more effective in improving pregnancy outcomes in normal pregnant women. 2. more effective in controlling blood glucose (BG) than standard clinic prenatal care in women with GDM.

Full description

Mobile technology and equipment based on Internet and communications technology have revolutionized the content and manner of social interaction and services. Mobile medical care has just started, the relevant platform and service is still immature, not standardized, poor satisfaction, low efficiency, its value and effectiveness of health management lack of clear theoretical support and data description. In this study, based on the multi-center prospective randomized controlled study, we constructed a large-scale maternal health service platform and a systematic standardized maternal health management model to carry out personalized maternal health management and mobile health services. Mobile medical effects validation, and further improve the mobile medical platform.

This study will verify the value of mobile health care for maternal health management, to establish a standardized standard mobile medical model, to further improve the level of domestic maternal health management and improve the quality of maternal and child health management.
Most gestational diabetes mellitus (GDM) can be well controlled by health education and life style management, expecting a better pregnancy outcome. But standard clinic prenatal care which consist of clinic visit every two weeks may not give full play to the effects of GDM management. Telemedicine shows its potential to fill this gap. A multicenter, randomized controlled trial was designed to investigate whether health education and life style management through WeChat group chat was more effective in controlling blood glucose (BG) than standard clinic prenatal care in women with GDM. Women with GDM diagnosed by oral glucose tolerance test between 23-30+6 gestational weeks were randomized to a WeChat group chat-based blood glucose management group or routine clinic prenatal care. In PUMCH, investigators also equip CGM for m-health group allowing a more detailed BG information. The primary outcome was change of glycemic qualification rate during follow up period in both groups. The second outcome was pregnancy outcomes. Also, a case control study is designed to compare the glucose control status between rice-richen meal and wheaten-richen meal, and all other macronutrients and micronutrients are all calculated and same between two groups, which may provide more clues for type of carbohydrate recommendation for Chinese women with GDM.

Enrollment

640 patients

Sex

Female

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Aged between 18 and 45 years.
With singleton pregnancy
Diagnosed or not diagnosed as GDM by 75g oral glucose tolerance test (OGTT) and insulin treatment is not required assessed by multi-disciplinary consultation.
Be able to use smart phone for chatting, read and write basic Chinese.
Volunteer for research.

Exclusion criteria