Promoting Fetal Movement Monitoring: Improving Birth Outcomes

• ClinicalTrials.gov Identifier: NCT01844011
• Recruitment Status: Completed
• First Posted: May 1, 2013
• Last Update Posted: December 13, 2019
• Sponsor: Mercy Medical Center
• Collaborator: First Candle Foundation
• Information provided by (Responsible Party): Michael Mullen, Mercy Medical Center

Tracking Information

• First Submitted Date: April 26, 2013
• First Posted Date: May 1, 2013
• Last Update Posted Date: December 13, 2019
• Study Start Date: March 2013
• Actual Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 26, 2013)

• Completion of Paper Chart [ Time Frame: 36 weeks pregnant-1 month status post delivery ]
  Completion of kick count charts at follow-up prenatal visits
• Knowledge of kick counting post delivery [ Time Frame: 36 weeks pregnant-1 month status 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

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Promoting Fetal Movement Monitoring: Improving Birth Outcomes
• Official Title: Promoting Fetal Movement Monitoring: Improving Birth Outcomes
• 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.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Prevention
• Condition: Fetal Kick Counting

Intervention

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

Study Arms

• 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.
  Intervention: Other: Daily electronic reminders
• 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.

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: January 6, 2014): 40
• Original Estimated Enrollment (submitted: April 26, 2013): 80
• Actual Study Completion Date: December 2013
• Actual Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01844011
• Other Study ID Numbers: MMC 2011-56
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Michael Mullen, Mercy Medical Center
• Original Responsible Party: Mercy Medical Center
• Current Study Sponsor: Mercy Medical Center
• Original Study Sponsor: Same as current
• Collaborators: First Candle Foundation

Investigators

• Principal Investigator: Kathy J Helzlsouer, MD; Mercy Medical Center
• Principal Investigator: Robert Atlas, MD; Mercy Medical Center

• PRS Account: Mercy Medical Center
• Verification Date: December 2019