ConstipationumpiraskausNCT02577471
The Function of Gastrointestinal Tract During Pregnancy
An observational study of Constipation, run by Kuopio University Hospital at 1 site in Finland.
Trial summary
In this prospective study the function of gastrointestinal tract was assessed using constipation questionnaire (Rome criteria and bowel function index). Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Constipation
- How many people
- 1,000 participants
- Where
- 1 siteFinland
- Study dates
- Jul 2012to Oct 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: 400 pregnant ladies, 400 ladies who had delivered within three weeks and 200 control ladies who were not pregnant
Who may be able to join
- informed consent obtained
- pregnancy, delivery
- female non pregnant
Who cannot join
- no informed consent
- male
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
- Conditions
- Constipation
- Keywords
- Constipation, pregnancy, delivery
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Bowel function
participants filled bowel function questionnaires
Measured: one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2015 (estimated)
- Study startJul 2012
- Primary completionOct 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ConstipationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kuopio University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Merja Kokki, Kuopio University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02577471
- Sponsor's protocol ID
- KUH01062012
- Acronym
- umpiraskaus
- Status last verified
- Oct 2015
- First submitted
- 14 Oct 2015
- Last updated
- 16 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Function of Gastrointestinal Tract During Pregnancy and After Delivery
- ClinicalTrials.gov ID
- NCT02577471
- Acronym / sponsor ID
- umpiraskaus / KUH01062012
- Conditions
- Constipation
- Keywords
- Constipation, pregnancy, delivery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Kuopio University HospitalUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 16 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this prospective study the function of gastrointestinal tract was assessed using constipation questionnaire (Rome criteria and bowel function index).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- 400 pregnant ladies, 400 ladies who had delivered within three weeks and 200 control ladies who were not pregnant
Key inclusion criteria (3 listed)
- informed consent obtained
- pregnancy, delivery
- female non pregnant
Key exclusion criteria (2 listed)
- no informed consent
- male
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Bowel function
Time frame: one week
participants filled bowel function questionnaires
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2015.
Related trials for Constipation
Recruiting
Outcome Research in Bowel Irrigation Techniques for the Treatment of Chronic Constipation and/or Faecal Incontinence
Faecal Incontinence, Chronic Constipation
Active, not recruitingPhase 2
This is a Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel-group Study of the Efficacy and Safety of 2 Weight-based Treatment Groups of Plecanatide Versus Placebo in Children and Adolescent Participants 6 to Less Than 18 Years of Age With FC
Functional Constipation (FC)
Not yet recruiting
Acupuncture Combined With Transcutaneous Electrical Acupoint Stimulation for Constipation-Predominant Irritable Bowel Syndrome With Anxiety State
IBS, Constipation Predominant, Anxiety State
Not yet recruitingPhase 3
Rifaximin Treatment in Bloating Predominant Functional Bowel Disorders
Bloating, Rifaximin
Recruiting
Effects of Connective Tissue Massage Plus Biofeedback for Dyssynergic Defecation
Dyssynergic Defecation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Constipation, run by Kuopio University Hospital at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bowel function (time frame: one week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2015.