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

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ClinicalTrials.gov Identifier: NCT03499925
Recruitment Status : Not yet recruiting
First Posted : April 17, 2018
Last Update Posted : April 20, 2018
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital

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.

Condition or disease Intervention/treatment Phase
Pregnancy-related Complications Behavioral: cognitive behaviors Behavioral: Telephone consultation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: Theory Construction and Effect of Intervention on Pregnant Women With Gestational Hypertension and Endocrine Disorders
Estimated Study Start Date : April 23, 2018
Estimated Primary Completion Date : July 31, 2021
Estimated Study Completion Date : July 31, 2021

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03499925


Contacts
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Contact: Shiow-Ru Chang 02-2312-3456 ext 88425 srchang@ntu.edu.tw

Locations
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Taiwan
National Taiwan University Hospital Not yet recruiting
Taipei, Taiwan, 10051
Contact: Shiow-Ru Chang, PHD    02-2312-3456 ext 88425    srchang@ntu.edu.tw   
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
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Principal Investigator: Shiow-Ru Chang, PHD PHD

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Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT03499925     History of Changes
Other Study ID Numbers: 201801053RINB
First Posted: April 17, 2018    Key Record Dates
Last Update Posted: April 20, 2018
Last Verified: March 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by National Taiwan University Hospital:
mental health
intervention
pregnancy-related complications

Additional relevant MeSH terms:
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Hypertension
Endocrine System Diseases
Hypertension, Pregnancy-Induced
Vascular Diseases
Cardiovascular Diseases
Pregnancy Complications