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

Gestational Diabetes Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03726008
• Other study ID #: KMUHIRB-SV(I)-20160055
• Status: Terminated
• Phase: N/A
• Start date: January 22, 2018
• Est. completion date: July 31, 2020

Study information

• Verified date: April 2019
• Source: Kaohsiung Medical University Chung-Ho Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 120
• Est. completion date: July 31, 2020
• Est. primary completion date: July 31, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes, Gestational
• Gestational Diabetes

Intervention

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

Locations

Country	Name	City	State
Taiwan	Kaohsiung Medical University Chung-Ho Memorial Hospital	Kaohsiung City	Sanmin Dist

Sponsors (1)

Lead Sponsor	Collaborator
Kaohsiung Medical University Chung-Ho Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes of biological indicator	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	Changes of maternal body weight	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.
Secondary	Changes of maternal height	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.
Secondary	Changes of newborn body weight	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.
Secondary	Changes of newborn body length	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.
Secondary	Changes of newborn head circumference	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.
Secondary	Changes of newborn Apgar score	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.
Secondary	Health information of newborn	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.
Secondary	Changes of diabetes management self-efficacy Scale	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.
Secondary	Changes of postpartum stress	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.
Secondary	Changes of depression	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 a 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.
Secondary	Changes of health status	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 a 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.
Secondary	Changes of blood pressure	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.
Secondary	Changes of body mass index	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.
Secondary	Basic information of maternal	Women's age, education, occupation, family income, marriage, pregnancy and production history	women's six-month gestational age