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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2011 by Taipei Medical University WanFang Hospital.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01280474
First Posted: January 20, 2011
Last Update Posted: January 20, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Taipei Medical University WanFang Hospital
  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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Yi-Hua Chen, School of Public Health, Taipei Medical University
ClinicalTrials.gov Identifier: NCT01280474     History of Changes
Other Study ID Numbers: 99071
First Submitted: January 19, 2011
First Posted: January 20, 2011
Last Update Posted: January 20, 2011
Last Verified: January 2011

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

Additional relevant MeSH terms:
Depression
Behavioral Symptoms