Prenatal Education Video Study



Status:Completed
Conditions:Healthy Studies
Therapuetic Areas:Other
Healthy:No
Age Range:15 - Any
Updated:11/30/2013
Start Date:March 2010
End Date:May 2013
Contact:Ann Kellams, MD
Email:alk9c@virginia.edu
Phone:(434) 924-5899

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A randomized, controlled trial will be conducted during which pregnant women will be
randomized to receive the intervention - viewing a prenatal education video about how to
breastfeed an infant - or the sham intervention - viewing a prenatal education video about
maternal nutrition and physical activity during pregnancy. Participants will be interviewed
via telephone at one, three, and six months post-partum to determine how they feed their
infants at each of these time frames.


Research assistants will screen potential candidates at the University of Virginia Health
System and Virginia Commonwealth University Primary Care Center and approach potential
participants during a standard clinic visit. The charts of the day's patients will be
screened prior to approaching women to invite them to enroll in the study.

Following administration of the enrollment questionnaire, the patient will be randomized to
the intervention or sham intervention arm of the study. The research assistant will open
the study packet with the corresponding study identification number containing the
intervention assignment. The research assistant will then load the assigned video into the
DVD player and ask the patient to view the video. The participants will be blinded to which
video is the true intervention.

Following delivery, research assistants will abstract the medical records of the woman and
infant. Data regarding complications for both the mother and baby will be recorded and the
length of stay for mother and baby as well as information about the way in which the baby
was fed during the hospital stay.

Participants will be administered a one-month follow-up questionnaire by telephone.
Follow-up questionnaires will be administered by research staff that did not enroll the
participant such that the research assistant administering the telephone questionnaire will
be blinded to the patient's assigned intervention group. The three-month questionnaire will
be administered by telephone in the same fashion as the one-month. The six-month
questionnaire will be administered by telephone. This questionnaire will conclude the
study. A current address will be obtained at this time, and a children's book will be
mailed to the participant thanking her for completing the study. For subjects lost to
follow-up, we will contact the baby's pediatrician to retrieve the information on the
questionnaires.

Inclusion Criteria:

- Receiving prenatal care at the Primary Care Center, University Physicians for Women
at Northridge, the University of Virginia Teen Health Center

- WIC-eligible 185% Federal poverty Enrolled in Medicaid, TANF, food stamps

- Pregnant, 24 - 41 weeks gestation

- Singleton gestation

- Access to a telephone

- Plan to deliver at UVa

- Primary language is English or Spanish

Exclusion Criteria:

- Multiple gestation

- Known contraindication to breastfeeding Illicit drug use HIV + Recipient of
chemotherapy

- Primary language other than English or Spanish
We found this trial at
2
sites
Richmond, Virginia 23298
(804) 828-0100
Virginia Commonwealth University Since our founding as a medical school in 1838, Virginia Commonwealth University...
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1215 Lee St
Charlottesville, Virginia 22903
(434) 924-0211
University of Virginia Health System UVA Health System includes a 604-bed hospital, level I trauma...
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