Promoting Fetal Movement Monitoring: Improving Birth Outcomes
1 other identifier
interventional
40
1 country
1
Brief Summary
The purpose of the study is to find out the best way to help pregnant women keep track of their baby's movements. During pregnancy, feeling your baby's movements is normal. A decrease in movement can indicate potential problems with your baby's well-being. This study will see if daily electronic reminders and kick count charts help women to better track their baby's movements over the last weeks of pregnancy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2013
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2013
CompletedFirst Submitted
Initial submission to the registry
April 26, 2013
CompletedFirst Posted
Study publicly available on registry
May 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedDecember 13, 2019
December 1, 2019
9 months
April 26, 2013
December 11, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Completion of Paper Chart
Completion of kick count charts at follow-up prenatal visits
36 weeks pregnant-1 month status post delivery
Knowledge of kick counting post delivery
Baseline questionnaire, including knowledge questions regarding monitoring baby's movement and kick count methods can be compared to post-education kick count knowledge questionnaire, week 36 questionnaire and end of study questionnaire
36 weeks pregnant-1 month status post delivery
Study Arms (2)
Daily electronic reminders
EXPERIMENTALWomen in the intervention arm will be sent either daily text messages on the weekdays on their cell phone or emails on the weekdays reminding them to track kick counts on the chart.
Education only
NO INTERVENTIONAll women enrolled in the trial will receive a paper-based kick count chart, will be educated in the use of the kick count chart, and will be instructed to keep track of their fetal movements on a daily basis.
Interventions
Women in the intervention arm will be sent either daily text messages on the weekdays on their cell phone or emails on the weekdays reminding them to track kick counts on the chart
Eligibility Criteria
You may qualify if:
- weeks pregnant
- able to receive daily text messages or emails
- years of age or older
- willing to sign informed consent
You may not qualify if:
- unable to sign informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mercy Medical Centerlead
- First Candle Foundationcollaborator
Study Sites (1)
Mercy Medical Center
Baltimore, Maryland, 21202, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Kathy J Helzlsouer, MD
Mercy Medical Center
- PRINCIPAL INVESTIGATOR
Robert Atlas, MD
Mercy Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Administration
Study Record Dates
First Submitted
April 26, 2013
First Posted
May 1, 2013
Study Start
March 1, 2013
Primary Completion
December 1, 2013
Study Completion
December 1, 2013
Last Updated
December 13, 2019
Record last verified: 2019-12