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Completed

NCT Number: NCT03216044

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • age of consent
  • must be german-speaking

Exclusion criteria

  • no written consent

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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

  1. 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

Sponsors and collaborators

Lead sponsor

University Hospital Tuebingen

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Jul 12, 2017
Registry last updated
Jul 12, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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