Promoting Fetal Movement Monitoring: Improving Birth Outcomes

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.

Study Overview

• Status: Completed
• Conditions: Fetal Kick Counting
• Intervention / Treatment: Other: Daily electronic reminders

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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21202
      • Mercy Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Daily electronic reminders; 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.	Other: Daily electronic reminders; 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
No Intervention: Education only; All 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Mercy Medical Center
• Collaborators: First Candle Foundation
• Investigators: Principal Investigator: Kathy J Helzlsouer, MD, Mercy Medical Center; Principal Investigator: Robert Atlas, MD, Mercy Medical Center

Study record dates

Study Major Dates

• Study Start: March 1, 2013
• Primary Completion (Actual): December 1, 2013
• Study Completion (Actual): December 1, 2013

Study Registration Dates

• First Submitted: April 26, 2013
• First Submitted That Met QC Criteria: April 26, 2013
• First Posted (Estimate): May 1, 2013

Study Record Updates

• Last Update Posted (Actual): December 13, 2019
• Last Update Submitted That Met QC Criteria: December 11, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Keywords: pregnancy; fetal movement
• Other Study ID Numbers: MMC 2011-56