Clinical trial NCT00503672: Assessment of Activity in Pregnancy Using an Actigraph
Official title: Assessment of Activity in Pregnancy Using an Actigraph
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Motor Activity
Pregnancy
Keywords: Motor Activity
Pregnancy
Accelerometer
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
First posted: 2007-07-19
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant Women

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.

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

Primary outcomes:
measure: Actigraphy data points
timeFrame: The periods for wear have been selected such that they coincide with visits for routine prenatal screening.
Secondary outcomes:
Other outcomes:
Locations:
city: Long Beach
country: United States
facility: Long Beach Memorial Medical Center, Miller Children's Hospital
state: California
city: Orange
country: United States
facility: University of California, Irvine
state: California
Study officials:
affiliation: University of California, Irvine
name: Deborah A Wing, MD
role: PRINCIPAL_INVESTIGATOR
References: