Clinical trial NCT03726008: The Effect of a Perinatal Health Promotion Program on the Different Levels of Gestational Hyperglycemic Women
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Gestational Diabetes
Lead sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital
Sponsor class: OTHER
First posted: 2018-10-31
Enrollment: 120
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: PREVENTION

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.

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.

Eligibility 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.

Primary outcomes:
measure: Changes of biological indicator
timeFrame: 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 outcomes:
measure: Changes of maternal body weight
timeFrame: 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.
measure: Changes of maternal height
timeFrame: 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.
measure: Changes of newborn body weight
timeFrame: about 2 days after hospitalization for childbirth, and six weeks after childbirth, six months after childbirth, and one year after childbirth.
measure: Changes of newborn body length
timeFrame: about 2 days after hospitalization for childbirth, and six weeks after childbirth, six months after childbirth, and one year after childbirth.
measure: Changes of newborn head circumference
timeFrame: about 2 days after hospitalization for childbirth, and six weeks after childbirth, six months after childbirth, and one year after childbirth.
measure: Changes of newborn Apgar score
timeFrame: about 2 days after hospitalization for childbirth, and six weeks after childbirth, six months after childbirth, and one year after childbirth.
measure: Health information of newborn
timeFrame: about 2 days after hospitalization for childbirth, and six weeks after childbirth, six months after childbirth, and one year after childbirth.
measure: Changes of diabetes management self-efficacy Scale
timeFrame: 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.
measure: Changes of postpartum stress
timeFrame: about 2 days after hospitalization for childbirth, and six weeks after childbirth, six months after childbirth, and one year after childbirth.
measure: Changes of depression
timeFrame: 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.
measure: Changes of health status
timeFrame: 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.
measure: Changes of blood pressure
timeFrame: 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.
measure: Changes of body mass index
timeFrame: 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.
measure: Basic information of maternal
timeFrame: women's six-month gestational age
Other outcomes:
Locations:
city: Kaohsiung City
country: Taiwan
facility: Kaohsiung Medical University Chung-Ho Memorial Hospital
state: Sanmin Dist
Study officials:
affiliation: Kaohsiung Medical University
name: Hsiang-Chi Yu, Master
role: PRINCIPAL_INVESTIGATOR
References: