Effects of Maternal Depressive Symptomatology on Pregnancy Outcomes and Newborn Development --- How is Paternal Psychopathology Involved?

NCT ID: NCT01280474

Last Updated: 2011-01-20

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-08-31
• Study Completion Date: 2013-08-31

Brief Summary

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.

Conditions

Depression; Pregnancy

Study Design

• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• Women who are pregnant within the gestational week of 14 (the first trimester) and have a prenatal visit at the selected hospitals.
• Women who expect to carry the baby to term.
• Women who are willing to provide information on their spouse or partner. And their spouse or partner also expresses the willingness to participate.

Exclusion Criteria

• Pregnant women who are unable to provide information on their spouse or partner.
• Pregnant women's spouse or partner is unable to participate in this study.
• Pregnant women or their spouse or partner have difficulties in appropriately reading and completing a Chinese version questionnaire (e.g., illiteracy, not familiar with Chinese (e.g., foreign spouse), have major psychiatric illness, etc.)
• Women who are not appropriate to participate based upon doctoral or professional evaluation.

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Taipei Medical University WanFang Hospital

OTHER

Sponsor Role: lead

Responsible Party

School of Public Health, Taipei Medical University

Principal Investigators

Yi-Hua Chen

Role: PRINCIPAL_INVESTIGATOR

Taipei Medical University

Locations

Taipei Medical University

Taipei, , Taiwan

Countries

Taiwan

Other Identifiers

99071

Identifier Type: -

Identifier Source: org_study_id