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Assessment of Activity in Pregnancy Using an Actigraph

This study has been withdrawn prior to enrollment.
(Data from the Actigraph devices could no longer be read/analyzed)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00503672
First Posted: July 19, 2007
Last Update Posted: November 8, 2017
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.
Information provided by (Responsible Party):
Deborah A. Wing, University of California, Irvine
  Purpose
We would like to quantify the amount and type of activity a typical pregnant woman engages in and then compare the pregnancy outcomes of women with varying activity levels. To do this, we will have women wear a device known as an accelerometer (that records activity by measuring changes in voltage levels) at certain times in their pregnancies.

Condition
Motor Activity Pregnancy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Assessment of Activity in Pregnancy Using an Actigraph

Further study details as provided by Deborah A. Wing, University of California, Irvine:

Primary Outcome Measures:
  • Actigraphy data points [ Time Frame: The periods for wear have been selected such that they coincide with visits for routine prenatal screening. ]
    This is an observational study whose primary objective is to obtain an estimate of the amount of activity that patients engage in during a pregnancy, divided among low, moderate, and high intensity levels.


Enrollment: 0
Actual Study Start Date: July 2007
Study Completion Date: September 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Detailed Description:

General findings that have consistently been demonstrated in the literature are that activity tends to decreased during pregnancy from pre-pregnancy levels and that activity in the third trimester is less than in the first trimester. In non-pregnant patients, increase in physical activity and exercise has been associated with improved mood and self-esteem. Although the data in pregnancy is limited, available studies do suggest that inactivity is associated with worse mood. Regular physical activity is not detrimental in low-risk patients and in fact may be beneficial.

Bed rest or activity restrictions are commonly employed interventions for women with a variety of obstetric complications such as preterm contractions, vaginal bleeding, and fetal growth restriction. There is no compelling data to support bed rest as an effective therapeutic modality. There has been some data that occupational work can increase the risk of preterm birth, but other studies have not demonstrated an effect.5 Furthermore, prolonged bedrest can have detrimental effects such as muscle weakness and increased thromboembolic risk, as well as negatively impact familial relations.

The use of the accelerometer is an attempt to objectively quantify physical activity in pregnancy. The accelerometer assesses activity by measuring voltages, and can thus provide information on the intensity of activity. An additional advantage is that it can be worn on the wrist or ankle, whereas pedometers need to be worn on the waist for maximal accuracy which limits their use in pregnant women. This novel study would contribute to the existing literature on pregnancy activity that consists primarily of survey/subjective data to determine what correlation, if any, exists between activity and pregnancy outcome. Secondarily, the study will survey its participants to see if we can corroborate previous studies that have demonstrated a relationship between activity level and patients' moods.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Pregnant Women
Criteria

Inclusion Criteria:

  • Nulliparous
  • First trimester (11-14w)
  • No medical contraindications to normal activity

Exclusion Criteria:

  • Chronic medical conditions that require restricted activity (cardiac disease, severe asthma, etc)
  • Known fetal anomalies
  • Morbid obesity (BMI > 39)
  • Maternal age less than 18 years
  • Inability to comply with instructions
  Contacts and Locations
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): NCT00503672


Locations
United States, California
Long Beach Memorial Medical Center, Miller Children's Hospital
Long Beach, California, United States, 90806
University of California, Irvine
Orange, California, United States, 92868
Sponsors and Collaborators
University of California, Irvine
Investigators
Principal Investigator: Deborah A Wing, MD University of California, Irvine
  More Information

Responsible Party: Deborah A. Wing, Director of Maternal Fetal Medicine, University of California, Irvine
ClinicalTrials.gov Identifier: NCT00503672     History of Changes
Other Study ID Numbers: 2006-5343
First Submitted: July 18, 2007
First Posted: July 19, 2007
Last Update Posted: November 8, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Deborah A. Wing, University of California, Irvine:
Motor Activity
Pregnancy
Accelerometer