- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03216044
Chronic Pain After Childbirth - Caesarean Section Compared to Vaginal Delivery and the Impact of Pre-existing Pain
July 10, 2017 updated by: University Hospital Tuebingen
Incidence and Predictors of Chronic Pain After Vaginal Childbirth and C-section - a Prospective Cohort Study
There is no doubt, that surgery is very often the beginning of a chronic pain disorder.
C-section is a worldwide performed operation with increasing trend in the developed countries .This prospective cohort study evaluated the incidence of persistent pain after childbirth in respect of the pain status before childbirth and the modus of delivery.
Study Overview
Status
Completed
Conditions
Detailed Description
There are different variables that may influence the occurrence of chronic pain after childbirth.
One of these could be c- section , pain status before childbirth or other psychological factors like fear of birth, irrational cognitive beliefs about delivery and perinatal complications.
The pain status (intensity and location), demographic data, anesthesiological details and data about the circumstances of birth are evaluated by structured interview during pregnancy and 3 month and 12 moth after childbirth.
The pregnant women received an individual code for access to the survey on the website of the study.
The recruitment takes placed in doctors or midwifes office and by advertising.
The commuting area was the city of Tuebingen (Germany).
Women who feel uncomfortable with the media based survey supplied a written form.
Study population is planned with 500 participants.
The Institute for Clinical Epidemiology and Applied Biometry support the statistical analysis.
Study Type
Observational
Enrollment (Actual)
355
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 and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Probability Sample
Study Population
pregnant women living in the city of Tuebingen and Stuttgart or the area surrounding
Description
Inclusion Criteria:
- age of consent
- must be german-speaking
Exclusion Criteria:
- no written consent
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of new chronic pain disorder after vaginal delivery and after c-section
Time Frame: 3 months after delivery
|
Surgery is often mentioned as cause of persistent postsurgical pain.
C-section procedure could be related to the development of chronic pain after childbirth.
|
3 months after delivery
|
Incidence of new chronic pain disorder after vaginal delivery and after c-section
Time Frame: 12 month after delivery
|
Surgery is often mentioned as cause of persistent postsurgical pain.
C-section procedure could be related to the development of chronic pain after childbirth.
|
12 month after delivery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Quality of Life (SF 12) after 12 months of delivery
Time Frame: 12 months after delivery
|
The 12-Item Short Form Health Survey (SF-12) was developed for Medical Outcomes Study of patients with chronic conditions.
Analysis of SF 12 in woman with chronic pain and without chronic pain after delivery
|
12 months after delivery
|
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 (Actual)
January 1, 2013
Primary Completion (Actual)
January 1, 2017
Study Completion (Actual)
June 27, 2017
Study Registration Dates
First Submitted
June 28, 2017
First Submitted That Met QC Criteria
July 10, 2017
First Posted (Actual)
July 12, 2017
Study Record Updates
Last Update Posted (Actual)
July 12, 2017
Last Update Submitted That Met QC Criteria
July 10, 2017
Last Verified
January 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 451/2011BO2
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
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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