Chronic Pain After Childbirth - Caesarean Section Compared to Vaginal Delivery and the Impact of Pre-existing Pain

Chronic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03216044
• Other study ID #: 451/2011BO2
• Status: Completed
• Phase: N/A
• First received: June 28, 2017
• Last updated: July 10, 2017
• Start date: January 2013
• Est. completion date: June 27, 2017

Study information

• Verified date: January 2017
• Source: University Hospital Tuebingen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 childbirth and the modus of delivery.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 355
• Est. completion date: June 27, 2017
• Est. primary completion date: January 1, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• age of consent

• must be german-speaking

Exclusion Criteria:

• no written consent

Related Conditions & MeSH terms

• Chronic Pain

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Tuebingen

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3 months after delivery
Primary	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.	12 month after delivery
Secondary	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	12 months after delivery