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

NCT ID: NCT03748576

Last Updated: 2020-07-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 640 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-01
• Study Completion Date: 2020-05-31

Brief Summary

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.

Detailed Description

1. 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.

2. 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.

Conditions

Maternal Behavior; Mobile Health; Pregnancy Outcome; GDM; Blood Glucose; Diet Habit; Compliance, Patient

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Mobile technologies group

m-health group (Intervention Group) participants were managed continuously through WeChat group chat during prenatal clinic interval.

Group Type: EXPERIMENTAL

telemedicine: management through WeChat group chat

Intervention Type: BEHAVIORAL

Patients in intervention group received additional WeChat group management when conducted standard clinic prenatal care

control group

Standard Clinic Prenatal Care (Control Group): regular routine prenatal care following Chinese standard.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

telemedicine: management through WeChat group chat

Patients in intervention group received additional WeChat group management when conducted standard clinic prenatal care

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Pregnancies with diagnosed chronic disease
• Pregnancies with other pregnancy complications except GDM
• Pregnancies had recent trauma and treatment of glucocorticoids

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Peking Union Medical College Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

liangkun ma

Role: STUDY_DIRECTOR

Peking union medical college hosiptal

Locations

Department of ob gyn, Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Countries

China

References

Tian Y, Zhang S, Huang F, Ma L. Comparing the Efficacies of Telemedicine and Standard Prenatal Care on Blood Glucose Control in Women With Gestational Diabetes Mellitus: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2021 May 25;9(5):e22881. doi: 10.2196/22881.

Reference Type: DERIVED

PMID: 33783365 (View on PubMed)

Huang F, Zhang S, Tian Y, Li L, Li Y, Chen X, Sun X, Fan Y, Ma W, Liu C, Gao L, Xue X, Ma L. Effect of mobile health based peripartum management of gestational diabetes mellitus on postpartum diabetes: A randomized controlled trial. Diabetes Res Clin Pract. 2021 May;175:108775. doi: 10.1016/j.diabres.2021.108775. Epub 2021 Mar 23.

Reference Type: DERIVED

PMID: 33771645 (View on PubMed)

Other Identifiers

JS-1012

Identifier Type: -

Identifier Source: org_study_id