- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02577471
The Function of Gastrointestinal Tract During Pregnancy (umpiraskaus)
October 15, 2015 updated by: Merja Kokki, Kuopio University Hospital
The Function of Gastrointestinal Tract During Pregnancy and After Delivery
In this prospective study the function of gastrointestinal tract was assessed using constipation questionnaire (Rome criteria and bowel function index).
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
1000
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Northern savo
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Kuopio, Northern savo, Finland, 70029
- Kuopio University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Probability Sample
Study Population
400 pregnant ladies, 400 ladies who had delivered within three weeks and 200 control ladies who were not pregnant
Description
Inclusion Criteria:
- informed consent obtained
- pregnancy, delivery
- female non pregnant
Exclusion Criteria:
- no informed consent
- male
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
|---|
|
During pregnancy
Pregnant ladies filled bowel function questionnaires
|
|
After delivery
ladies within three weeks of delivery filled bowel function questionnaires
|
|
Controls
Non pregnant ladies filled bowel function questionnaires
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Bowel function
Time Frame: one week
|
participants filled bowel function questionnaires
|
one week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2012
Primary Completion (Actual)
October 1, 2012
Study Completion (Actual)
October 1, 2012
Study Registration Dates
First Submitted
October 14, 2015
First Submitted That Met QC Criteria
October 15, 2015
First Posted (Estimate)
October 16, 2015
Study Record Updates
Last Update Posted (Estimate)
October 16, 2015
Last Update Submitted That Met QC Criteria
October 15, 2015
Last Verified
October 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- KUH01062012
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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