Epidemiology of Gallbladder Sludge and Stones in Pregnancy
2 other identifiers
interventional
1,196
1 country
1
Brief Summary
The specific objective of this project is to study the impact exercise has on gallstone formation during pregnancy when women are at increased risk due to biochemical and physiological alterations.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2003
Longer than P75 for not_applicable
1 active site
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
May 1, 2003
CompletedFirst Submitted
Initial submission to the registry
August 16, 2005
CompletedFirst Posted
Study publicly available on registry
August 17, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2009
CompletedOctober 6, 2017
October 1, 2017
5.5 years
August 16, 2005
October 5, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Development of gall bladder sludge or gallstones
Gallbladder sludge was defined as the presence of low amplitude echoes within the gallbladder without postacoustic shadowing, which could layer with positioning of the patient. Gallstones were defined as high amplitude echoes with postacoustic shadowing.
18 and 36 weeks gestation
Secondary Outcomes (3)
Insulin
18 and 36 weeks gestation
Leptin
18 and 36 weeks gestation
Adiponectin
18 and 36 weeks gestation
Study Arms (2)
Exercise
EXPERIMENTALThe intervention was an exercise program of moderate to vigorous intensity. The intervention started with 30-minute sessions three times per week, with the ultimate goal to have participants exercise four to five times per week for 45 to 60 minutes per session.
Control
NO INTERVENTIONWomen in the control group did not attend instructional sessions with the exercise interventionist and did not receive the motivational mailings
Interventions
Eligibility Criteria
You may qualify if:
- Pregnant
- Over 18 years of age
- Eligible for care at Madigan Army Medical Center
You may not qualify if:
- Prior gallbladder surgery
- Non-English speaking
- Medical reason not to exercise during pregnancy
- Moving from area within 3 months
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Madigan Army Medical Center
Tacoma, Washington, 98431, United States
Related Publications (1)
Ko CW, Napolitano PG, Lee SP, Schulte SD, Ciol MA, Beresford SA. Physical activity, maternal metabolic measures, and the incidence of gallbladder sludge or stones during pregnancy: a randomized trial. Am J Perinatol. 2014 Jan;31(1):39-48. doi: 10.1055/s-0033-1334455. Epub 2013 Mar 1.
PMID: 23456902RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sum P Lee, MD, PhD
University of Washington
- STUDY DIRECTOR
Shirley Beresford, PhD
University of Washington School of Public Health and Community Medicine
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 16, 2005
First Posted
August 17, 2005
Study Start
May 1, 2003
Primary Completion
November 1, 2008
Study Completion
December 1, 2009
Last Updated
October 6, 2017
Record last verified: 2017-10