ClinicalTrials.gg
Status unknownNCT03499925Updated Apr 20, 2018

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

An interventional study of cognitive behaviors and Telephone consultation in Pregnancy-related Complications, sponsored by National Taiwan University Hospital. Status unknown at 1 site in Taiwan. Open to female participants aged 20 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-04-20.

Sponsored by National Taiwan University Hospital · Not applicable, Interventional, and Supportive care

The sponsor has not verified this record recently (last verified Mar 2018), so the status shown — last known as Not yet recruiting — may be out of date.

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Phase
Not applicable
Study type
Interventional
Enrollment
300
Allocation
Randomized
Ages
20 Years and older
Sex
Female
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 45 studies in Psychological Well-Being with a site in Taiwan — 17 open to participants now, 18 under way, none of them phase 3. Psychological Well-Being · Taiwan.

Planned enrollment
6th of 40
300 · median 94
Started
2018
with 1 other
No phase
40 of 45
13 open now
Registered
1st of 45
by date
Lead sponsor
7 of 45
National Taiwan University Hospital

Among the 45 studies in Psychological Well-Being with a site in Taiwan, this one is the 6th largest by planned enrollment of the 40 interventional ones that give a count, is one of 2 that started in 2018, is one of 40 with no phase, and was the 1st registered.

Psychological Well-Being

2,195 studies on the registry are indexed under Psychological Well-Being; 728 are open to participants now.

Browse Psychological Well-Being studies →

Open to participants now

17 of the 45 studies in Psychological Well-Being with a site in Taiwan are open now. Recruiting first, the newest first:

12 more — sign in →

All 17 open studies →

A study can be open while its sites in Taiwan have not opened yet or have stopped. Only those recruiting at a site in Taiwan →

Who these studies take

Of the 401 Psychological Well-Being studies recruiting now, 218 (54%) set no upper age limit and 157 (39%) stop at 75 or younger; 120 take children under 18; 204 take healthy volunteers.

This study: 20 Years and older · female · healthy volunteers too.

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02

Study 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.

03

Conditions studied

  • Pregnancy-related Complications

Keywords

  • mental health
  • intervention
  • pregnancy-related complications
04

Who can participate

Ages eligible
20 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
300 participants (estimated)

Study arms

  • Experimental
    Test Group

    Telephone consultation effectiveness and cognitive behaviors

    Behavioral: cognitive behaviors · Behavioral: Telephone consultation

  • No intervention
    Comparison Group

    Routine product inspection

Interventions

  • Behavioralcognitive behaviors

    Telephone consultation effectiveness and cognitive behaviors

  • BehavioralTelephone consultation

    Telephone consultation effectiveness and cognitive behaviors

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: one week

07

Study locations

1 site
  • National Taiwan University Hospital
    Taipei, 10051, Taiwan
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Apr 2018; primary completion for Jul 2021, 39 months later.

Of 1,261 non-industry interventional studies with no phase under Psychological Well-Being, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 34. This study's planned 39 months is above that.

Counting every sponsor, half of 1,304 studies reached it within 16 months; a quarter within 7 and three quarters within 34.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 28, 2018
First posted
Apr 17, 2018
StartEst.
Apr 23, 2018
Primary completionEst.
Jul 31, 2021
CompletionEst.
Jul 31, 2021
Last update
Apr 20, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 20, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03499925
Responsible party
Sponsor
First posted
Apr 17, 2018
Start date
Apr 23, 2018 (estimated)
Primary completion
Jul 31, 2021 (estimated)
Completion
Jul 31, 2021 (estimated)
Last update
Apr 20, 2018

Study contacts

Shiow-Ru Chang
Contact
srchang@ntu.edu.tw
02-2312-3456 ext. 88425
Shiow-Ru Chang, PHD
principal investigator · PHD

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.

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