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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by Taipei Medical University WanFang Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Taipei Medical University WanFang Hospital
ClinicalTrials.gov Identifier:
NCT01280474
First received: January 19, 2011
Last updated: NA
Last verified: January 2011
History: No changes posted
  Purpose

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.


Condition
Depression
Pregnancy

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Effects of Maternal Depressive Symptomatology on Pregnancy Outcomes and Newborn Development --- How is Paternal Psychopathology Involved?

Further study details as provided by Taipei Medical University WanFang Hospital:

Estimated Enrollment: 300
Study Start Date: August 2010
Estimated Study Completion Date: August 2013
  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Pregnant women and their spouses

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01280474

Locations
Taiwan
Taipei Medical University
Taipei, Taiwan
Sponsors and Collaborators
Taipei Medical University WanFang Hospital
Investigators
Principal Investigator: Yi-Hua Chen Taipei Medical University
  More Information

No publications provided

Responsible Party: Yi-Hua Chen, School of Public Health, Taipei Medical University
ClinicalTrials.gov Identifier: NCT01280474     History of Changes
Other Study ID Numbers: 99071
Study First Received: January 19, 2011
Last Updated: January 19, 2011
Health Authority: Taiwan: Department of Health

Keywords provided by Taipei Medical University WanFang Hospital:
depression during pregnancy
postpartum depression
pregnancy outcomes
newborn development
paternal psychopathology

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 22, 2014