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Promoting Fetal Movement Monitoring: Improving Birth Outcomes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01844011
Recruitment Status : Completed
First Posted : May 1, 2013
Last Update Posted : December 13, 2019
Sponsor:
Collaborator:
First Candle Foundation
Information provided by (Responsible Party):
Michael Mullen, Mercy Medical Center

Study Description
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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.

Condition or disease Intervention/treatment Phase
Fetal Kick Counting Other: Daily electronic reminders Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Promoting Fetal Movement Monitoring: Improving Birth Outcomes
Study Start Date : March 2013
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013
Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Completion of Paper Chart [ Time Frame: 36 weeks pregnant-1 month status post delivery ]
    Completion of kick count charts at follow-up prenatal visits

  2. 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


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01844011


Locations
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United States, Maryland
Mercy Medical Center
Baltimore, Maryland, United States, 21202
Sponsors and Collaborators
Mercy Medical Center
First Candle Foundation
Investigators
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Principal Investigator: Kathy J Helzlsouer, MD Mercy Medical Center
Principal Investigator: Robert Atlas, MD Mercy Medical Center
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Michael Mullen, Administration, Mercy Medical Center
ClinicalTrials.gov Identifier: NCT01844011    
Other Study ID Numbers: MMC 2011-56
First Posted: May 1, 2013    Key Record Dates
Last Update Posted: December 13, 2019
Last Verified: December 2019
Keywords provided by Michael Mullen, Mercy Medical Center:
fetal movement
pregnancy