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A Multicenter Prospective Controlled Study of Mobile Health for Maternal Health Management

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03748576
Recruitment Status : Completed
First Posted : November 21, 2018
Last Update Posted : November 21, 2018
Sponsor:
Collaborators:
Fu Xing Hospital, Capital Medical University
Beijing Pinggu District Hospital
Beijing Dongcheng First Maternal and Child Health Hospital
Beijing Haidian Maternal and Child Health Hospital
Pinggu Maternal&Child Health Hospital
Amcare Women's & Children's Hosipal
Information provided by (Responsible Party):
Liangkun Ma, Peking Union Medical College Hospital

Brief Summary:

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, the investigators 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.


Condition or disease Intervention/treatment Phase
Maternal Behavior Mobile Health Pregnancy Outcome Behavioral: Mobile technologies Not Applicable

Detailed Description:
Eligibility Criteria:1.20 to 45 year old healthy women 2.There are no major internal and surgical chronic diseases during pregnancy 3.Chinese or foreign Chinese people A single pregnant woman with health care in Beijing perinatal conditions is allowed to perform maternal and child care 4.Follow-up

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Multicenter Prospective Controlled Study of Mobile Health for Maternal Health Management
Actual Study Start Date : November 1, 2017
Actual Primary Completion Date : October 31, 2018
Actual Study Completion Date : November 1, 2018

Arm Intervention/treatment
Experimental: Mobile technologies group
  1. The assessment and counselling on diet was performed with a four to six week interval on mobile phones .Participants were encouraged to engage in 30 min of moderate-intensity physical activity on three additional days per week.
  2. Health management team develops a series of online prenatal education curriculums for participants in the intervention group by mobile techologies.
  3. participants receive periodic educational mobile messages about professional pregnancy .
  4. The study team organizes regular online salon with information on our trial and the value of regular exercise and healthy diet in pregnancy.
  5. The management team creates a WeChat group in which participants can discuss various issues with each other.
Behavioral: Mobile technologies
intervent diet and exercise during pregancy by mobile technologies

Placebo Comparator: control group
regular routine prenatal care following Chinese standard. Routine care includes advices on prenatal nutrition, physical activity
Behavioral: Mobile technologies
intervent diet and exercise during pregancy by mobile technologies




Primary Outcome Measures :
  1. Maternal outcome [ Time Frame: up to 40 weeks ]
    The qualified rate of gestational weight gain

  2. Child outcome [ Time Frame: up to 40 weeks ]
    The inciendence of macrosomia



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Healthy women aged 20 to 45 years old
  2. No major internal and surgical chronic diseases during pregnancy
  3. Chinese population or foreign Chinese population
  4. Single birth and have condition of follow-up for mother and baby.

Exclusion criteria:

(1) those pregnant women who are dissenting with participating in this topic


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03748576


Locations
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China, Beijing
Department of ob gyn, Peking Union Medical College Hospital
Beijing, Beijing, China, 100730
Sponsors and Collaborators
Peking Union Medical College Hospital
Fu Xing Hospital, Capital Medical University
Beijing Pinggu District Hospital
Beijing Dongcheng First Maternal and Child Health Hospital
Beijing Haidian Maternal and Child Health Hospital
Pinggu Maternal&Child Health Hospital
Amcare Women's & Children's Hosipal
Investigators
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Study Director: liangkun ma Peking union medical college hosiptal
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Responsible Party: Liangkun Ma, Obstetrics and Gynecology, Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT03748576    
Other Study ID Numbers: 03092013
First Posted: November 21, 2018    Key Record Dates
Last Update Posted: November 21, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No