Effects of Maternal Depressive Symptomatology on Pregnancy Outcomes and Newborn Development --- How is Paternal Psychopathology Involved?
Recruitment status was Active, not recruiting
|First Received Date ICMJE||January 19, 2011|
|Last Updated Date||January 19, 2011|
|Start Date ICMJE||August 2010|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||No Changes Posted|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Effects of Maternal Depressive Symptomatology on Pregnancy Outcomes and Newborn Development --- How is Paternal Psychopathology Involved?|
|Official Title ICMJE||Effects of Maternal Depressive Symptomatology on Pregnancy Outcomes and Newborn Development --- How is Paternal Psychopathology Involved?|
This study aims at investigating the effects of maternal depressive symptomatology on pregnancy outcomes and newborn development. How paternal psychopathology is involved in the association will also be explored.
This is a three-year prospective cohort study. Three versions of questionnaires (the mother, the father, and the infant) will be developed first. For parents, data on self-reported symptomatology such as depression, anxiety, and stress will be collected, while for infants, maternal report on newborn development will be measured. Then, two medical centers and two regional hospitals will be selected. All pregnant women who undergo a first-trimester prenatal visit, who plan to carry the baby till term, and whose spouse is also willing to participate will be invited to join the study. The investigators expect to recruit a total of 194 pairs of depressive mothers and her spouses and 278 pairs of non-depressive mothers and her spouses in the study.
After the informed consent is obtained, one baseline assessment (i.e., the first trimester) and four follow-up assessments (i.e., the second trimester, the third trimester, one month postnatal and six months postnatal) will be implemented. Basically, prenatal investigation (for both mothers and fathers) will be carried out at the outpatient prenatal visit. Postnatal investigation (for the mothers, fathers and infants) will be processed at the pediatric outpatient visit when the infants are schedule for an immunization injection. After data are collected, descriptive, analytic and longitudinal data analyses will be performed to investigate the association between parental psychopathology and pregnancy outcomes and newborn development.
This study will explore the effects of the developmental trajectories of parental psychopathology on newborn growth during the critical stage of pregnancy. It is hoped that evidence based data could be obtained, examined, and applied in future prevention-intervention program to promote parental and newborn health, both physically and psychologically.
|Detailed Description||Not Provided|
|Study Type ICMJE||Observational|
|Study Design ICMJE||Time Perspective: Prospective|
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Non-Probability Sample|
Pregnant women and their spouses
|Intervention ICMJE||Not Provided|
|Study Group/Cohort (s)||Not Provided|
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Active, not recruiting|
|Estimated Enrollment ICMJE||300|
|Estimated Completion Date||August 2013|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Ages||20 Years and older|
|Accepts Healthy Volunteers||Yes|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Location Countries ICMJE||Taiwan|
|NCT Number ICMJE||NCT01280474|
|Other Study ID Numbers ICMJE||99071|
|Has Data Monitoring Committee||No|
|Responsible Party||Yi-Hua Chen, School of Public Health, Taipei Medical University|
|Study Sponsor ICMJE||Taipei Medical University WanFang Hospital|
|Collaborators ICMJE||Not Provided|
|Information Provided By||Taipei Medical University WanFang Hospital|
|Verification Date||January 2011|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP