Association Between Chronic Headache and Back Pain With Childbirth

Sponsor
Stanford University (Other)
Overall Status
Completed
CT.gov ID
NCT04091321
Collaborator
(none)
1,112
1
5.5
203.9

Study Details

Study Description

Brief Summary

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

Detailed Description

Chronic headache and back pain have an excess prevalence in women as compared to men. This study uses a single survey that uses logic to assess for association between childbirth and chronic headache and between childbirth and chronic back pain using screening questions. The questions are, "Do you suffer from chronic headaches" and "Do you suffer from chronic back pain". Depending on the answer to the screening question, the subject will be given further questions only related to the syndrome that they endorsed.

Arm 1) There is an association between chronic headache and childbirth over and above raising children. Secondary outcomes are temporal association between onset or worsening of headache and childbirth, association between migraine headache and childbirth, association between chronic headache and anesthetic complications.

Arm 2) There is an association between chronic back pain and childbirth over and above raising children. Secondary outcomes are temporal association between onset or worsening of back pain and childbirth, association between chronic headache and anesthesia.

Study Design

Study Type:
Observational
Actual Enrollment :
1112 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Association Between Chronic Headache and Back Pain With Childbirth
Actual Study Start Date :
Sep 13, 2019
Actual Primary Completion Date :
Feb 26, 2020
Actual Study Completion Date :
Feb 26, 2020

Arms and Interventions

Arm Intervention/Treatment
Chronic Headache

Women who endorse chronic headache

Chronic Back Pain

Women who endorse chronic back pain

Outcome Measures

Primary Outcome Measures

  1. Chronic headache [10 minute questionnaire]

    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

  2. Chronic back pain [10 minute questionnaire]

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

Secondary Outcome Measures

  1. Migraine [10 minute questionnaire]

    Percent of patients with migraine who gave birth to children/Percent of patients with migraine who did not gave birth

  2. Temporal coincidence of headache and childbirth [10 minute questionnaire]

    Women who developed or had worse headache within one year of delivery compared to one year of starting to raise a child not delivered

  3. Temporal coincidence of headache and dural puncture [10 minute questionnaire]

    Women who developed or had worse headache within one year of dural puncture compared to those who did not have a dural puncture

Other Outcome Measures

  1. Temporal coincidence of back pain and regional anesthesia [10 minute questionnaire]

    Women who developed or had worse back pain within one year of regional anesthesia compared to those who did not have regional anesthesia

Eligibility Criteria

Criteria

Ages Eligible for Study:
10 Years and Older
Sexes Eligible for Study:
Female
Inclusion Criteria:
  • Female representation
Exclusion Criteria:
  • None

Contacts and Locations

Locations

Site City State Country Postal Code
1 Lucille Packard Children's Hospital Palo Alto California United States 94305

Sponsors and Collaborators

  • Stanford University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Pamela Flood, Professor, Stanford University
ClinicalTrials.gov Identifier:
NCT04091321
Other Study ID Numbers:
  • 52732
First Posted:
Sep 16, 2019
Last Update Posted:
Sep 24, 2021
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 24, 2021