NCT03726008

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 26, 2017

Completed
27 days until next milestone

Study Start

First participant enrolled

January 22, 2018

Completed
9 months until next milestone

First Posted

Study publicly available on registry

October 31, 2018

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2020

Completed
Last Updated

March 4, 2021

Status Verified

April 1, 2019

Enrollment Period

2.5 years

First QC Date

December 26, 2017

Last Update Submit

March 2, 2021

Conditions

Gestational Diabetes

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (14)

  • Changes of maternal body weight

    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

    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

    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

    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

    about 2 days after hospitalization for childbirth, and six weeks after childbirth, six months after childbirth, and one year after childbirth.

  • +9 more secondary outcomes

Study Arms (2)

Experimental group

EXPERIMENTAL

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

Behavioral: Perinatal health promotion program and regular prenatal care

Control group

NO INTERVENTION

The control group will receive the regular perinatal care

Interventions

Perinatal health promotion program and regular prenatal careBEHAVIORAL

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

Experimental group

Eligibility Criteria

Age20 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailspregnant wemon
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Is immigrant.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, Sanmin Dist, 807, Taiwan

Location

MeSH Terms

Conditions

Diabetes, Gestational

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Hsiang-Chi Yu, Master

    Kaohsiung Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 26, 2017

First Posted

October 31, 2018

Study Start

January 22, 2018

Primary Completion

July 31, 2020

Study Completion

July 31, 2020

Last Updated

March 4, 2021

Record last verified: 2019-04

Locations

TW(1)