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

Completed

• Conditions: Chronic Pain

• Registration Number: NCT03216044
• Lead Sponsor: University Hospital Tuebingen

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.

Study Timeline

• Study Start: 2013-01
• Status Verified: 2017-01
• Primary Completion: 2017-01-01
• Study Completion: 2017-06-27
• Study First Submitted: 2017-06-28
• Study First Submitted QC: 2017-07-10
• Last Update Submitted: 2017-07-10
• Study First Posted: 2017-07-12
• Last Update Posted: 2017-07-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 355

Inclusion Criteria

• age of consent
• must be german-speaking

Exclusion Criteria

• no written consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of new chronic pain disorder after vaginal delivery and after c-section	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 Outcome Measures

Name	Time	Method
Quality of Life (SF 12) after 12 months of delivery	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