Assessment of Activity in Pregnancy Using an Actigraph

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.

Study Overview

• Status: Withdrawn
• Conditions: Pregnancy; Motor Activity

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.

• Study Type: Observational

Contacts and Locations

Study Locations

• United States
  • California
    • Long Beach, California, United States, 90806
      • Long Beach Memorial Medical Center, Miller Children's Hospital
    • Orange, California, United States, 92868
      • University of California, Irvine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Pregnant Women

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Actigraphy data points	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.	The periods for wear have been selected such that they coincide with visits for routine prenatal screening.

Collaborators and Investigators

• Sponsor: University of California, Irvine
• Investigators: Principal Investigator: Deborah A Wing, MD, University of California, Irvine

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2007
• Primary Completion (Actual): August 1, 2010
• Study Completion (Actual): September 1, 2010

Study Registration Dates

• First Submitted: July 18, 2007
• First Submitted That Met QC Criteria: July 18, 2007
• First Posted (Estimate): July 19, 2007

Study Record Updates

• Last Update Posted (Actual): November 8, 2017
• Last Update Submitted That Met QC Criteria: November 6, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: Pregnancy; Motor Activity; Accelerometer
• Other Study ID Numbers: 2006-5343

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO