Skip to main content
OpenTrials
Completed

NCT Number: NCT03748576

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Department of ob gyn, Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

About this study

  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

telemedicine: management through WeChat group chat

Behavioral

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

Primary outcomes

  1. weight gain during pregnancy

    Time frame: up to 40 gestatinal weeks

    Participants record their body weight twice a month. Weight gain from third-trimester and the whole pregnancy period are calculated.

  2. Glycemic qualification rate in women with GDM

    Time frame: From enrollment to 42 days postpartum

    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)

Secondary outcomes

  1. The incidence rate of specific pregnant outcomes in both normal pregnant women and women with GDM

    Time frame: at delivery

    pregnancy outcomes include delivery mode, premature rupture of the membranes, preterm birth, SGA, LGA and postpartum hemorrhage

Sponsors and collaborators

Lead sponsor

Peking Union Medical College Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2020
First posted
Nov 21, 2018
Registry last updated
Jul 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.