NCT03216044

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
355

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2013

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 27, 2017

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

June 28, 2017

Completed
14 days until next milestone

First Posted

Study publicly available on registry

July 12, 2017

Completed
Last Updated

July 12, 2017

Status Verified

January 1, 2017

Enrollment Period

4 years

First QC Date

June 28, 2017

Last Update Submit

July 10, 2017

Conditions

Chronic Pain

Keywords

childbirthcaesarean deliveryvaginal deliverychronic painpainful sexual intercourse

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (1)

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

    12 months after delivery

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

pregnant women living in the city of Tuebingen and Stuttgart or the area surrounding

You may qualify if:

  • age of consent
  • must be german-speaking

You may not qualify if:

  • \- no written consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Chronic PainDyspareunia

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGenital Diseases, MaleSexual Dysfunction, PhysiologicalMale Urogenital DiseasesSexual Dysfunctions, PsychologicalMental Disorders

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 28, 2017

First Posted

July 12, 2017

Study Start

January 1, 2013

Primary Completion

January 1, 2017

Study Completion

June 27, 2017

Last Updated

July 12, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share