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

Study Overview
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Brief Summary
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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.

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

Conditions
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Pregnancy-related Complications

Intervention / Treatment
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* Behavioral: cognitive behaviors
* Behavioral: Telephone consultation


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test Group<br>Telephone consultation effectiveness and cognitive behaviors | Behavioral: cognitive behaviors<br>* Telephone consultation effectiveness and cognitive behaviors<br>Behavioral: Telephone consultation<br>* Telephone consultation effectiveness and cognitive behaviors<br>|
| No Intervention: Comparison Group<br>Routine product inspection | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | one week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mental health, intervention, pregnancy-related complications