Prenatal Education Video Study

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

Breastfeeding

Clinical Trial Details

NCT number	NCT01623128
Study type	Interventional
Source	University of Virginia
Contact
Status	Completed
Phase	N/A
Start date	March 2010
Completion date	July 2013

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT00579605` - Motivational Interviewing to Promote Sustained Breastfeeding	N/A
Completed	`NCT05655364` - Development of a Breastfeeding Supportive Mobile Application	N/A
Completed	`NCT03853850` - Using Mobile Phone Text Messaging System to Improve Exclusive Breastfeeding Rate in a Resource-poor Caribbean Island	N/A
Completed	`NCT03957941` - FamilyLink and Breastfeeding	N/A
Withdrawn	`NCT03709004` - Pacifiers and Breastfeeding Among Mothers at Risk for Postpartum Depression	N/A
Completed	`NCT02958475` - Mother's Milk Messaging: Evaluation of a Bilingual Application (APP) to Support Initiation and Exclusive Breastfeeding in New Mothers	N/A
Active, not recruiting	`NCT05503069` - Community Interventions to Improve Breastfeeding	N/A
Not yet recruiting	`NCT02233439` - Double-blind, Placebocontrolled A Randomized Trial on the Efficacy of Herbal Galactogogues	N/A
Completed	`NCT01893736` - Professional Breastfeeding Support Intervention	N/A
Completed	`NCT02738957` - Effect of Prenatal Counseling on Breastfeeding Rates in Twins	N/A
Completed	`NCT00527956` - Facilitation and Barriers to Breastfeeding in the NICU	N/A
Completed	`NCT03655314` - Using the Electronic Health Record to Guide Management of Newborn Weight Loss	N/A
Completed	`NCT05562245` - Motivational Interviewing-Based Breastfeeding Education	N/A
Completed	`NCT05106634` - Evaluation of Breastfeeding Success and Self-Efficacy in Mothers Giving Birth Via Vaginal Delivery or Cesarean Section
Completed	`NCT05992753` - Mothers' Breast Milk Expression Experiences, Infant Feeding Attitudes and Perceived Social Support Levels
Recruiting	`NCT05213975` - Kinesio Taping Application After Cesarean Section	N/A
Recruiting	`NCT05250219` - Microchimeric Cell Tranfer From Mother to Child - Pilo Study
Recruiting	`NCT05371106` - Mycotoxins in Mothers Milk in Israel
Completed	`NCT03332108` - Novel Approach To Improving Lactation Support With Mobile Health Technology	N/A
Completed	`NCT02901665` - Impact of Increased Parent Presence in the Neonatal Intensive Care Unit on Parent & Infant Outcomes	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Prenatal Education Video Study — PEVS

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms