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

Diet Habit Clinical Trial

Official title:

Clinical Research on Mobile Medical Used for the Management of Pregnant Women: a Randomized Control Trail

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03748576
• Other study ID #: JS-1012
• Status: Completed
• Phase: N/A
• Start date: November 1, 2017
• Est. completion date: May 31, 2020

Study information

• Verified date: October 2018
• Source: Peking Union Medical College Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 640
• Est. completion date: May 31, 2020
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• telemedicine: management through WeChat group chat
Patients in intervention group received additional WeChat group management when conducted standard clinic prenatal care

Locations

Country	Name	City	State
China	Department of ob gyn, Peking Union Medical College Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	weight gain during pregnancy	Participants record their body weight twice a month. Weight gain from third-trimester and the whole pregnancy period are calculated.	up to 40 gestatinal weeks
Primary	Glycemic qualification rate in women with GDM	Glycemic qualification rate was calculated by the number of BG within the control range /30*100%. BG control range were fasting BG (fasting and before-sleep BG)#95 mg/dL (5.3 mmol/L) and two-hour postprandial BG (post-breakfast, post-lunch, post-dinner BG)#120 mg/dL (6.7 mmol/L)	From enrollment to 42 days postpartum
Secondary	The incidence rate of specific pregnant outcomes in both normal pregnant women and women with GDM	pregnancy outcomes include delivery mode, premature rupture of the membranes, preterm birth, SGA, LGA and postpartum hemorrhage	at delivery