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

K

Kaohsiung Medical University

Status

Terminated

Conditions

Gestational Diabetes

Treatments

Behavioral: Perinatal health promotion program and regular prenatal care

Study type

Interventional

Funder types

Other

Identifiers

NCT03726008
KMUHIRB-SV(I)-20160055

Details and patient eligibility

About

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.

Full 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.

Enrollment

120 patients

Sex

Female

Ages

20+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose

Prevention

Allocation

Non-Randomized

Interventional model

Sequential Assignment

Masking

None (Open label)

120 participants in 2 patient groups

Experimental group
Experimental group
Description:
The experimental group will receive the perinatal health promotion program and regular prenatal care
Treatment:
Behavioral: Perinatal health promotion program and regular prenatal care
Control group
No Intervention group
Description:
The control group will receive the regular perinatal care

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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