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Theory Construction and Effect of Intervention on Pregnant Women With Gestational Hypertension and Endocrine Disorders

Primary Purpose

Pregnancy-related Complications

Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
cognitive behaviors
Telephone consultation
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Pregnancy-related Complications focused on measuring mental health, intervention, pregnancy-related complications

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion criteria

  1. age less than or equal to 20
  2. pregnancy less than 35 weeks
  3. CES-D questionnaire score greater than or equal to 16 points or State-Trait Anxiety Inventory-State(STAI-S) questionnaire score greater than 40 points
  4. Ability to speak Chinese or Taiwanese, or willing to use translation services to help complete questionnaires and interventions
  5. Ability to complete follow-up visits and electronic surveys
  6. Agree to participate in the study and sign the consent form

Exclusion criteria

  1. People with chronic diseases or congenital diseases before pregnancy.
  2. Women who are not scheduled to continue to undergo probation or production at the study site.
  3. Those who have major mental illnesses and are unable to complete self-administered questionnaires.

Sites / Locations

  • National Taiwan University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Test Group

Comparison Group

Arm Description

Telephone consultation effectiveness and cognitive behaviors

Routine product inspection

Outcomes

Primary Outcome Measures

CES-D
The Center for Epidemiological Studies-Depression (CES-D) scale asked the subject how often depressive symptoms had occurred in the past week. There were four frequencies: no, very few (less than one day per week), sometimes (every Monday to two days), and frequent (three to seven days per week). Options To assess each symptom, score 0 to 3 for each question. After the forward question is scored backwards, the total score for the 20 questions is between 0 and 60. Radloff Radloff suggested that the results should be explained by the total score of the scale. The total score is suggested to be interpreted by the total score of the scale. The total score is recommended to be explained by the total score of the scale, and the total score is recommended to be explained by the total score of the scale. The higher the total score, the more severe the depressive symptoms.

Secondary Outcome Measures

Full Information

First Posted
March 28, 2018
Last Updated
April 18, 2018
Sponsor
National Taiwan University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03499925
Brief Title
Theory Construction and Effect of Intervention on Pregnant Women With Gestational Hypertension and Endocrine Disorders
Official Title
Theory Construction and Effect of Intervention on Pregnant Women With Gestational Hypertension and Endocrine Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Unknown status
Study Start Date
April 23, 2018 (Anticipated)
Primary Completion Date
July 31, 2021 (Anticipated)
Study Completion Date
July 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Few reports have addressed mental health for women with pregnancy complication over a prolonged time period. Meanwhile, the caring model with intervention for women who have pregnancy complication needs to be developed. The aims of this study are to (1) describe and compare the differences in health indicators during pre-pregnancy, pregnancy and 1 year postpartum; (2) develop the theoretical framework of relationship among health indicators during perinatal period; (3) develop a telephone follow-up and consultation program and examine its effect on women's resilience, depression, anxiety and quality of life. In the first stage, a prospective longitudinal investigation will be performed in women at pregnancy and postpartum. Women with pregnancy-related complications will be recruited. All participants will complete questionnaires that assess demographic characteristics, obstetric and birth history, depression, anxiety, resilience and quality of life. Participants who are in early, middle, late pregnancy, 3-5 days, 1st, 3rd, and 6th month and 1 year postpartum will be contacted to complete the questionnaires by mail or at study site clinics. The sample size was estimated by drop rates and power calculation. Approximately 380 women in early pregnancy will be recruited at a medical center in northern Taiwan. The first stage of this study will be conducted over a 3-year period. In the second stage, randomized control trial with single blind will be used to recruit eligible subjects from women in the waiting room for prenatal examination at a medical center in Taipei. The eligible subjects will be randomized into a control or experimental group. The women in the control group will receive usual care and those in the experimental group will receive four instances of telephone follow-up or face-to-face consultation. Two groups will receive 3 times measurements of depressive symptom, anxiety, resilience and quality of life. Meanwhile, Investigators will assess the health indicators of women's newborn. Data will be analyzed by independent t-test and generalized estimating equations. Forty-eight subjects will be recruited in each group. Totally, 300 subjects will be approached in terms of including a 30% dropout rate. The second stage of this study will be conducted over a 2-year period.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pregnancy-related Complications
Keywords
mental health, intervention, pregnancy-related complications

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Test Group
Arm Type
Experimental
Arm Description
Telephone consultation effectiveness and cognitive behaviors
Arm Title
Comparison Group
Arm Type
No Intervention
Arm Description
Routine product inspection
Intervention Type
Behavioral
Intervention Name(s)
cognitive behaviors
Intervention Description
Telephone consultation effectiveness and cognitive behaviors
Intervention Type
Behavioral
Intervention Name(s)
Telephone consultation
Intervention Description
Telephone consultation effectiveness and cognitive behaviors
Primary Outcome Measure Information:
Title
CES-D
Description
The Center for Epidemiological Studies-Depression (CES-D) scale asked the subject how often depressive symptoms had occurred in the past week. There were four frequencies: no, very few (less than one day per week), sometimes (every Monday to two days), and frequent (three to seven days per week). Options To assess each symptom, score 0 to 3 for each question. After the forward question is scored backwards, the total score for the 20 questions is between 0 and 60. Radloff Radloff suggested that the results should be explained by the total score of the scale. The total score is suggested to be interpreted by the total score of the scale. The total score is recommended to be explained by the total score of the scale, and the total score is recommended to be explained by the total score of the scale. The higher the total score, the more severe the depressive symptoms.
Time Frame
one week

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion criteria age less than or equal to 20 pregnancy less than 35 weeks CES-D questionnaire score greater than or equal to 16 points or State-Trait Anxiety Inventory-State(STAI-S) questionnaire score greater than 40 points Ability to speak Chinese or Taiwanese, or willing to use translation services to help complete questionnaires and interventions Ability to complete follow-up visits and electronic surveys Agree to participate in the study and sign the consent form Exclusion criteria People with chronic diseases or congenital diseases before pregnancy. Women who are not scheduled to continue to undergo probation or production at the study site. Those who have major mental illnesses and are unable to complete self-administered questionnaires.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shiow-Ru Chang
Phone
02-2312-3456
Ext
88425
Email
srchang@ntu.edu.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shiow-Ru Chang, PHD
Organizational Affiliation
PHD
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
10051
Country
Taiwan
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shiow-Ru Chang, PHD
Phone
02-2312-3456
Ext
88425
Email
srchang@ntu.edu.tw

12. IPD Sharing Statement

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Theory Construction and Effect of Intervention on Pregnant Women With Gestational Hypertension and Endocrine Disorders

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