NCT00503672

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jul 2007

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2007

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

July 18, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 19, 2007

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
Last Updated

November 8, 2017

Status Verified

November 1, 2017

Enrollment Period

3.1 years

First QC Date

July 18, 2007

Last Update Submit

November 6, 2017

Conditions

Motor ActivityPregnancy

Keywords

Motor ActivityPregnancyAccelerometer

Outcome Measures

Primary Outcomes (1)

  • 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.

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Pregnant Women

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Long Beach Memorial Medical Center, Miller Children's Hospital

Long Beach, California, 90806, United States

Location

University of California, Irvine

Orange, California, 92868, United States

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Deborah A Wing, MD

    University of California, Irvine

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Maternal Fetal Medicine

Study Record Dates

First Submitted

July 18, 2007

First Posted

July 19, 2007

Study Start

July 1, 2007

Primary Completion

August 1, 2010

Study Completion

September 1, 2010

Last Updated

November 8, 2017

Record last verified: 2017-11

Data Sharing

IPD Sharing
Will not share

Locations

US(2)