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Clinical Trials/NCT03216044
NCT03216044
Completed
Not Applicable

Incidence and Predictors of Chronic Pain After Vaginal Childbirth and C-section - a Prospective Cohort Study

University Hospital Tuebingen0 sites355 target enrollmentJanuary 2013
ConditionsChronic Pain

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Pain
Sponsor
University Hospital Tuebingen
Enrollment
355
Primary Endpoint
Incidence of new chronic pain disorder after vaginal delivery and after c-section
Status
Completed
Last Updated
8 years ago

Overview

Brief 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 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.

Registry
clinicaltrials.gov
Start Date
January 2013
End Date
June 27, 2017
Last Updated
8 years ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • age of consent
  • must be german-speaking

Exclusion Criteria

  • no written consent

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Quality of Life (SF 12) after 12 months of delivery(12 months after delivery)

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