Pregnancy-related ComplicationsNCT03499925
Theory Construction and Effect of Intervention on Pregnant Women With Gestational Hypertension and Endocrine Disorders
A study testing cognitive behaviors and Telephone consultation in people with Pregnancy-related Complications, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy-related Complications
- What is being tested?
- cognitive behaviors and Telephone consultation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteTaiwan
- Study dates
- 23 Apr 2018to 31 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
National Taiwan University Hospital
Taipei, 10051
Shiow-Ru Chang, PHD, 02-2312-3456 ext. 88425, srchang@ntu.edu.tw
About this study
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.
- Conditions
- Pregnancy-related Complications
- Being tested
- cognitive behaviors, Telephone consultation
- Keywords
- mental health, intervention, pregnancy-related complications
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cognitive behaviorsBehavioural
Telephone consultation effectiveness and cognitive behaviors
Telephone consultationBehavioural
Telephone consultation effectiveness and cognitive behaviors
| Study group | Role | What they receive |
|---|---|---|
| Test Group | Experimental | Telephone consultation effectiveness and cognitive behaviors Receives: Behavioral: cognitive behaviors; Behavioral: Telephone consultation |
| Comparison Group | No intervention | Routine product inspection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2018
- Study start23 Apr 2018 (estimated)
- Primary completion31 Jul 2021 (estimated)
- Study completion31 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy-related ComplicationsStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shiow-Ru Chang, PHD, Principal investigator, PHD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03499925
- Sponsor's protocol ID
- 201801053RINB
- Status last verified
- Mar 2018
- First submitted
- 28 Mar 2018
- Last updated
- 20 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Theory Construction and Effect of Intervention on Pregnant Women With Gestational Hypertension and Endocrine Disorders
- ClinicalTrials.gov ID
- NCT03499925
- Acronym / sponsor ID
- 201801053RINB
- Conditions
- Pregnancy-related Complications
- Keywords
- mental health, intervention, pregnancy-related complications
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 23 Apr 2018 (estimated)
- Primary completion
- 31 Jul 2021 (estimated)
- Study completion
- 31 Jul 2021 (estimated)
- First posted
- 17 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test Group | Experimental | Behavioral: cognitive behaviors, Behavioral: Telephone consultationTelephone consultation effectiveness and cognitive behaviors |
| Comparison Group | No intervention | –Routine product inspection |
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cognitive behaviorsTelephone consultation effectiveness and cognitive behaviors | Behavioural | Test Group |
| Telephone consultationTelephone consultation effectiveness and cognitive behaviors | Behavioural | Test Group |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shiow-Ru Chang, PHD principal investigator
PHD
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cognitive behaviors and Telephone consultation in people with Pregnancy-related Complications, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shiow-Ru Chang (02-2312-3456 ext. 88425, srchang@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CES-D (time frame: one week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2018.