Assessment of Activity in Pregnancy Using an Actigraph

NCT ID: NCT00503672

Last Updated: 2017-11-08

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2007-07-31
• Study Completion Date: 2010-09-30

Brief Summary

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.

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.

Conditions

Motor Activity; Pregnancy

Keywords

Motor Activity; Pregnancy; Accelerometer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of California, Irvine

OTHER

Sponsor Role: lead

Responsible Party

Deborah A. Wing

Director of Maternal Fetal Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Deborah A Wing, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, Irvine

Locations

Long Beach Memorial Medical Center, Miller Children's Hospital

Long Beach, California, United States

University of California, Irvine

Orange, California, United States

Countries

United States

Other Identifiers

2006-5343

Identifier Type: -

Identifier Source: org_study_id