Chronic PainNCT03216044
Chronic Pain After Childbirth - Caesarean Section Compared to Vaginal Delivery and the Impact of Pre-existing Pain
An observational study of Chronic Pain, run by University Hospital Tuebingen.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Chronic Pain
- How many people
- 355 participants
- Where
- No sites listed yet
- Study dates
- Jan 2013to 27 Jun 2017
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: pregnant women living in the city of Tuebingen and Stuttgart or the area surrounding
Who may be able to join
- age of consent
- must be german-speaking
Who cannot join
- no written consent
About this study
Official title: 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.
Read the 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.
- Conditions
- Chronic Pain
- Keywords
- childbirth, caesarean delivery, vaginal delivery, chronic pain, painful sexual intercourse
- Medical subject headings
- Chronic Pain, Dyspareunia
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of new chronic pain disorder after vaginal delivery and after c-section
Surgery is often mentioned as cause of persistent postsurgical pain. C-section procedure could be related to the development of chronic pain after childbirth.
Measured: 3 months after delivery
Incidence of new chronic pain disorder after vaginal delivery and after c-section
Surgery is often mentioned as cause of persistent postsurgical pain. C-section procedure could be related to the development of chronic pain after childbirth.
Measured: 12 month after delivery
Secondary outcomes (1)
Quality of Life (SF 12) after 12 months of 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
Measured: 12 months after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2017
- Study startJan 2013
- Primary completion1 Jan 2017
- Study completion27 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by University Hospital TuebingenThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 355 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03216044
- Sponsor's protocol ID
- 451/2011BO2
- Status last verified
- Jan 2017
- First submitted
- 28 Jun 2017
- Last updated
- 12 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence and Predictors of Chronic Pain After Vaginal Childbirth and C-section - a Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT03216044
- Acronym / sponsor ID
- 451/2011BO2
- Conditions
- Chronic Pain
- Keywords
- childbirth, caesarean delivery, vaginal delivery, chronic pain, painful sexual intercourse
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 355 participants (actual)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Study start
- Jan 2013 (actual)
- Primary completion
- 1 Jan 2017 (actual)
- Study completion
- 27 Jun 2017 (actual)
- First posted
- 12 Jul 2017 (actual)
- 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.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- pregnant women living in the city of Tuebingen and Stuttgart or the area surrounding
Key inclusion criteria (2 listed)
- age of consent
- must be german-speaking
Key exclusion criteria (1 listed)
- no written consent
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
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.
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.
1 secondary outcome
Quality of Life (SF 12) after 12 months of delivery
Time frame: 12 months after delivery
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 12 Jul 2017.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Pain, run by University Hospital Tuebingen.
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 2 inclusion and 1 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 12 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Incidence of new chronic pain disorder after vaginal delivery and after c-section (time frame: 3 months after delivery). The study lists 2 primary outcomes in all. 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 12 Jul 2017.