Clinical trial NCT01844011: Promoting Fetal Movement Monitoring: Improving Birth Outcomes
Official title: Promoting Fetal Movement Monitoring: Improving Birth Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fetal Kick Counting
Keywords: fetal movement
pregnancy
Lead sponsor: Mercy Medical Center
Sponsor class: OTHER
Collaborators: name: First Candle Foundation
First posted: 2013-05-01
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Detailed description: Pregnant women coming to the Hoffman and Associates or the Center for Advanced Fetal Care at Mercy Medical Center for their prenatal care and delivery may join this study. You must be able to receive daily text messages on your cell phone or have access to a computer to check daily emails in order to take part in the study. It is expected that 80 pregnant women will take part in this study. The study will end within a month after the delivery of your baby.

There is some evidence in the published literature suggesting that maternal monitoring of fetal movement may improve fetal mortality rates and infant health. Kick counting is a specific strategy to monitor fetal movement. Kick counts are typically performed in a daily 10-minute increment or until a specified number of "kicks" has been counted. In general, keeping track of kick counts begins in the 28th week of pregnancy, or earlier for high-risk pregnancies. Keeping track of kick counts allows the mother to monitor her baby's normal activity pattern and to identify when the baby's movement may decrease.

This study will be conducted to examine whether daily electronic reminders, sent using either cell phone text messages or computer-based emails, delivered in conjunction with the use of a paper-based kick count chart, increases the likelihood of completion of the paper-based kick count chart as well as knowledge regarding use of kick count methods compared to the paper-based kick count chart alone.

Eligibility criteria: Inclusion Criteria:

* 24-28 weeks pregnant
* able to receive daily text messages or emails
* 18 years of age or older
* willing to sign informed consent

Exclusion Criteria:

-unable to sign informed consent

Primary outcomes:
measure: Completion of Paper Chart
timeFrame: 36 weeks pregnant-1 month status post delivery
measure: Knowledge of kick counting post delivery
timeFrame: 36 weeks pregnant-1 month status post delivery
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Mercy Medical Center
state: Maryland
Study officials:
affiliation: Mercy Medical Center
name: Kathy J Helzlsouer, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Mercy Medical Center
name: Robert Atlas, MD
role: PRINCIPAL_INVESTIGATOR
References: