NCT04091321

Brief Summary

This study uses a single questionnaire to evaluate two separate primary outcomes:

  1. 1.To identify association between chronic headache in women who have given birth to children as compared to a control group of women who have raised children but have not given birth to them
  2. 2.To identify association between chronic back pain in women who have given birth to children as compared to a control group of women who have raised children but have not given birth to them

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,112

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 12, 2019

Completed
1 day until next milestone

Study Start

First participant enrolled

September 13, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 16, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 26, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 26, 2020

Completed
Last Updated

September 24, 2021

Status Verified

September 1, 2021

Enrollment Period

6 months

First QC Date

September 12, 2019

Last Update Submit

September 18, 2021

Conditions

Headache Disorders, SecondaryPost-Dural Puncture HeadacheMigraine DisordersBack PainAnesthesia

Outcome Measures

Primary Outcomes (2)

  • Chronic headache

    Percent of patients with chronic headache who gave birth to children/Percent of patients with chronic headache who raised children but did not gave birth

    10 minute questionnaire

  • Chronic back pain

    Percent of patients with chronic back pain who gave birth to children/Percent of patients with chronic back pain who did not gave birth

    10 minute questionnaire

Secondary Outcomes (3)

  • Migraine

    10 minute questionnaire

  • Temporal coincidence of headache and childbirth

    10 minute questionnaire

  • Temporal coincidence of headache and dural puncture

    10 minute questionnaire

Other Outcomes (1)

  • Temporal coincidence of back pain and regional anesthesia

    10 minute questionnaire

Study Arms (2)

Chronic Headache

Women who endorse chronic headache

Chronic Back Pain

Women who endorse chronic back pain

Eligibility Criteria

Age10 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Chronic pain patients who have elected to be contacted for research studies

You may qualify if:

  • Female representation

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lucille Packard Children's Hospital

Palo Alto, California, 94305, United States

Location

Related Publications (1)

  • Zhang M, Cooley C, Ziadni MS, Mackey I, Flood P. Association between history of childbirth and chronic, functionally significant back pain in later life. BMC Womens Health. 2023 Jan 3;23(1):4. doi: 10.1186/s12905-022-02023-2.

    PMID: 36597120DERIVED

MeSH Terms

Conditions

Headache Disorders, SecondaryPost-Dural Puncture HeadacheMigraine DisordersBack Pain

Condition Hierarchy (Ancestors)

Headache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesHeadache Disorders, PrimaryPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 12, 2019

First Posted

September 16, 2019

Study Start

September 13, 2019

Primary Completion

February 26, 2020

Study Completion

February 26, 2020

Last Updated

September 24, 2021

Record last verified: 2021-09

Locations

US(1)