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

April 18, 2018 updated by: National Taiwan University Hospital
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan, 10051
        • National Taiwan University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Test Group
Telephone consultation effectiveness and cognitive behaviors
Behavioral: cognitive behaviors
Telephone consultation effectiveness and cognitive behaviors
Behavioral: Telephone consultation
Telephone consultation effectiveness and cognitive behaviors
NO_INTERVENTION: Comparison Group
Routine product inspection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CES-D
Time Frame: one week
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.
one week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Investigators

  • Principal Investigator: Shiow-Ru Chang, PHD, PhD

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

April 23, 2018

Primary Completion (ANTICIPATED)

July 31, 2021

Study Completion (ANTICIPATED)

July 31, 2021

Study Registration Dates

First Submitted

March 28, 2018

First Submitted That Met QC Criteria

April 9, 2018

First Posted (ACTUAL)

April 17, 2018

Study Record Updates

Last Update Posted (ACTUAL)

April 20, 2018

Last Update Submitted That Met QC Criteria

April 18, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201801053RINB

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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