- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03726008
The Effect of a Perinatal Health Promotion Program on the Different Levels of Gestational Hyperglycemic Women
The Effect of a Perinatal Health Promotion Program on the Different Levels of Gestational Hyperglycemic Women's Bio-psycho-social Features and Child Growth
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Sanmin Dist
-
Kaohsiung City, Sanmin Dist, Taiwan, 807
- Kaohsiung Medical University Chung-Ho Memorial Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Experimental group
The experimental group will receive the 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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
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.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
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.
|
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)
|
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.
|
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)
|
about 2 days after hospitalization for childbirth, and six weeks after childbirth, six months after childbirth, and one year after childbirth.
|
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)
|
about 2 days after hospitalization for childbirth, and six weeks after childbirth, six months after childbirth, and one year after childbirth.
|
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)
|
about 2 days after hospitalization for childbirth, and six weeks after childbirth, six months after childbirth, and one year after childbirth.
|
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.
|
about 2 days after hospitalization for childbirth, and six weeks after childbirth, six months after childbirth, and one year after childbirth.
|
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.
|
about 2 days after hospitalization for childbirth, and six weeks after childbirth, six months after childbirth, and one year after childbirth.
|
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. |
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.
|
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. |
about 2 days after hospitalization for childbirth, and six weeks after childbirth, six months after childbirth, and one year after childbirth.
|
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.
|
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.
|
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.
|
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.
|
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)
|
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.
|
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)
|
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.
|
Basic information of maternal
Time Frame: women's six-month gestational age
|
Women's age, education, occupation, family income, marriage, pregnancy and production history
|
women's six-month gestational age
|
Collaborators and Investigators
Investigators
- Principal Investigator: Hsiang-Chi Yu, Master, Kaohsiung Medical University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KMUHIRB-SV(I)-20160055
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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