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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-22

Study Completion Date

2020-07-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Gestational Diabetes

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Experimental group

The experimental group will receive the perinatal health promotion program and regular prenatal care

Group Type EXPERIMENTAL

Perinatal health promotion program and regular prenatal care

Intervention Type BEHAVIORAL

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

Control group

The control group will receive the regular perinatal care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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.