MedTrace Logo

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

NCT03499925 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2018-04-20

No results posted yet for this 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.

Conditions

  • Pregnancy-related Complications

Interventions

BEHAVIORAL

cognitive behaviors

Telephone consultation effectiveness and cognitive behaviors

BEHAVIORAL

Telephone consultation

Telephone consultation effectiveness and cognitive behaviors

Sponsors & Collaborators

  • National Taiwan University Hospital

    lead OTHER

Principal Investigators

  • Shiow-Ru Chang, PHD · PHD

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-04-23
Primary Completion
2021-07-31
Completion
2021-07-31

Countries

  • Taiwan

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03499925 on ClinicalTrials.gov