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The Effect of a Perinatal Health Promotion Program on the Different Levels of Gestational Hyperglycemic Women

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ClinicalTrials.gov Identifier: NCT03726008
Recruitment Status : Recruiting
First Posted : October 31, 2018
Last Update Posted : June 13, 2019
Sponsor:
Information provided by (Responsible Party):
Kaohsiung Medical University Chung-Ho Memorial Hospital

Brief Summary:
Taiwan National Health Insurance system was launched in 1995 and the diagnosis and treatment for gestational diabetes mellitus were reimbursed. However, controversy regarding treatment and prevention programs for the other different levels of gestational hyperglycemia continues. Moreover, long-term follow-up studies for the impact of different levels of gestational hyperglycemia on women's perinatal consequences were not found. Thus, the purpose of the study, is to explore the effect of a perinatal health promotion program on three different levels of gestational hyperglycemic women's bio-psycho-social features and their offspring's development.

Condition or disease Intervention/treatment Phase
Gestational Diabetes Behavioral: Perinatal health promotion program and regular prenatal care Not Applicable

Detailed Description:
The investigators will recruit 120 women with three different levels of gestational hyperglycemia and assign them to either experimental group (a total of 60 women of gestational hyperglycemia) or control group (a total of 60 women of gestational hyperglycemia). Data will be collected at the women's six-month gestation, hospitalization for childbirth, and six weeks, six months, and one year postpartum. The three-year study findings can demonstrate the consequences and risk factors for women with three different levels of gestational hyperglycemia to suffer from type 2 diabetes mellitus. In addition, the results can be taken as an evidence-based intervention for the perinatal health promotion program in preventing the gestational hyperglycemic women to suffer from type 2 diabetes mellitus and in decreasing the impact of gestational hyperglycemia on the development of the gestational hyperglycemic women's offspring.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: The Effect of a Perinatal Health Promotion Program on the Different Levels of Gestational Hyperglycemic Women's Bio-psycho-social Features and Child Growth
Actual Study Start Date : January 22, 2018
Estimated Primary Completion Date : July 31, 2019
Estimated Study Completion Date : July 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Experimental group
The experimental group will receive the perinatal health promotion program and regular prenatal care
Behavioral: Perinatal health promotion program and regular prenatal care
Regular prenatal care and perinatal health promotion program including health promotion during pregnant period, health promotion during the ritual of Tso-Yueh-Tzu, health promotion during postpartum period, newborn care

No Intervention: Control group
The control group will receive the regular perinatal care



Primary Outcome Measures :
  1. Changes of biological indicator [ Time Frame: women's six-month gestational age, about 2 days after hospitalization for childbirth, and six weeks after childbirth, six months after childbirth, and one year after childbirth. ]
    Fasting blood glucose test


Secondary Outcome Measures :
  1. Changes of maternal body weight [ Time Frame: women's six-month gestational age, about 2 days after hospitalization for childbirth, and six weeks after childbirth, six months after childbirth, and one year after childbirth. ]
    Maternal body weight(weight in kilograms)

  2. Changes of maternal height [ Time Frame: women's six-month gestational age, about 2 days after hospitalization for childbirth, and six weeks after childbirth, six months after childbirth, and one year after childbirth. ]
    Maternal height(height in meters)

  3. Changes of newborn body weight [ Time Frame: about 2 days after hospitalization for childbirth, and six weeks after childbirth, six months after childbirth, and one year after childbirth. ]
    Newborn body weight (weight in grams)

  4. Changes of newborn body length [ Time Frame: about 2 days after hospitalization for childbirth, and six weeks after childbirth, six months after childbirth, and one year after childbirth. ]
    Newborn body length (length in centimeter)

  5. Changes of newborn head circumference [ Time Frame: about 2 days after hospitalization for childbirth, and six weeks after childbirth, six months after childbirth, and one year after childbirth. ]
    Newborn head circumference (length in centimeter)

  6. Changes of newborn Apgar score [ Time Frame: about 2 days after hospitalization for childbirth, and six weeks after childbirth, six months after childbirth, and one year after childbirth. ]
    The newborn Apgar score in 1 and 5 minutes.The test is generally done at 1 and 5 minutes after birth and may be repeated later if the score is and remains low. Scores 7 and above are generally normal; 4 to 6, fairly low; and 3 and below are generally regarded as critically low and cause for immediate resuscitative efforts.

  7. Health information of newborn [ Time Frame: about 2 days after hospitalization for childbirth, and six weeks after childbirth, six months after childbirth, and one year after childbirth. ]
    The newborn's health status and complications.

  8. Changes of diabetes management self-efficacy Scale [ Time Frame: women's six-month gestational age, about 2 days after hospitalization for childbirth, and six weeks after childbirth, six months after childbirth, and one year after childbirth. ]

    The Diabetes Management Self-efficacy Scale(DMSES) measures the individual's efficacy expectations for engaging in 20 type 2 diabetes self-management activities (Bijl et al., 1999).

    The scale is scored according to a 1-5 point numerical scale indicating the level of efficacy expectation the respondent has for each item with higher scores indicating greater levels of self-efficacy.


  9. Changes of postpartum stress [ Time Frame: about 2 days after hospitalization for childbirth, and six weeks after childbirth, six months after childbirth, and one year after childbirth. ]

    The 62-item Hung Postpartum Stress Scale (Hung PSS) is a valid and reliable tool for assessing women's postpartum stress during the 42-day postpartum period.

    Exploratory factor analysis indicated three components of postpartum stress: concerns about maternal role attainment, body changes and lack of social support (Hung, 2007) The Cronbach's alpha of the Hung PSS was 0.95. On a five-point Likert scale rating from 1 (not at all) - 5 (always), women rated each item on how often stress was perceived during the postpartum period. The score for postpartum stress was derived by summing all ratings, resulting in potential scores between 62-310. Higher values indicated a higher level of stress.


  10. Changes of depression [ Time Frame: women's six-month gestational age, about 2 days after hospitalization for childbirth, and six weeks after childbirth, six months after childbirth, and one year after childbirth. ]
    The 18-item Taiwanese Depression Questionnaire(TDQ) is widely used to screen for depression in Taiwan. The TDQ is a culture-specific, self-administered questionnaire; its sensitivity and specificity have been measured as 0.89 and 0.92, respectively (Lee, Yang, Lai, Chiu, & Chau, 2000). Using a 4-point Likert scale (i.e., 0-3), participants indicated whether and how often they experienced each item. Total scores ranged from 0 to 54; higher scores indicated more severe depression symptoms. The values of Cronbach's α at the five time points were .82 to .90.

  11. Changes of health status [ Time Frame: women's six-month gestational age, about 2 days after hospitalization for childbirth, and six weeks after childbirth, six months after childbirth, and one year after childbirth. ]
    We used the 12 items Chinese Health Questionnaire(CHQ) to measure perinatal women's health status (developed by Cheng (1985) and verified by Chong and Wilkinson (1989). Responses used a 4-point Likert scale (1 = not at all; 4 = most of the time). Responses of 1 or 2 were recoded as "0," responses of 3 or 4 were recoded as "1," and a total score ranging from 0 to 12 was calculated by summing the ratings (Chong & Wilkinson, 1989). The CHQ's sensitivity and specificity have been measured as 91.9% and 66.7%, respectively (Chong & Wilkinson, 1989); in this study, values of Cronbach's α ranged from .64 to .75 at the five time points.

  12. Changes of blood pressure [ Time Frame: women's six-month gestational age, about 2 days after hospitalization for childbirth, and six weeks after childbirth, six months after childbirth, and one year after childbirth. ]
    Blood pressure(with systolic, and diastolic)

  13. Changes of body mass index [ Time Frame: women's six-month gestational age, about 2 days after hospitalization for childbirth, and six weeks after childbirth, six months after childbirth, and one year after childbirth. ]
    Body mass index (kg/m^2)

  14. Basic information of maternal [ Time Frame: women's six-month gestational age ]
    Women's age, education, occupation, family income, marriage, pregnancy and production history



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   pregnant wemon
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:The woman who

  • Is 20 years old or above.
  • Has a positive test for gestational diabetes mellifluous with the 75% oral glucose tolerance test during 24~28 gestation.
  • Has junior high or above educational level.
  • Can speak Mandarin Chinese.
  • Is Taiwanese residence.
  • Plans to give a childbirth at the medical center.

Exclusion Criteria:The woman who

-Is immigrant.


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): NCT03726008


Contacts
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Contact: Chich-Hsiu Hung, PhD 07-3121107 ext 2601 chhung@kmu.edu.tw

Locations
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Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital Recruiting
Kaohsiung City, Sanmin Dist, Taiwan, 807
Contact: Chich-Hsiu Hung, PhD    07-3121101 ext 2601    chhung@kmu.edu.tw   
Principal Investigator: Hsiang-Chi Yu, Master         
Sponsors and Collaborators
Kaohsiung Medical University Chung-Ho Memorial Hospital
Investigators
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Principal Investigator: Hsiang-Chi Yu, Master Kaohsiung Medical University

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Responsible Party: Kaohsiung Medical University Chung-Ho Memorial Hospital
ClinicalTrials.gov Identifier: NCT03726008     History of Changes
Other Study ID Numbers: KMUHIRB-SV(I)-20160055
First Posted: October 31, 2018    Key Record Dates
Last Update Posted: June 13, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes, Gestational
Pregnancy Complications
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases