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Clinical Trials/NCT03499925
NCT03499925
Unknown
Not Applicable

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

National Taiwan University Hospital1 site in 1 country300 target enrollmentApril 23, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pregnancy-related Complications
Sponsor
National Taiwan University Hospital
Enrollment
300
Locations
1
Primary Endpoint
CES-D
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 23, 2018
End Date
July 31, 2021
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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.

Study Sites (1)

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