Evaluation of Headache and Childbirth in a Chronic Pain Population

Sponsor
Stanford University (Other)
Overall Status
Completed
CT.gov ID
NCT04632420
Collaborator
(none)
1,112
1
5.5
203.9

Study Details

Study Description

Brief Summary

Headache and backache are common symptoms following childbirth. The incidence of these symptoms have been shown to increase during the postpartum period between 5 to 12 months following delivery. By 12 months postpartum up to 45% and 65% of women experience headache and backache, respectively. While studies have reported headache and backache as frequently persistent symptoms beyond the first year postpartum, few studies have specifically interrogated women seeking specialist pain physician input or identified predisposing risk factors. Finally there is little known about typically described pain characteristics of women who suffer with chronic postpartum headache and backache. We aim to compare the prevalence of chronic headache in women that have versus have not experienced childbirth.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    1112 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Evaluation of Headache and Childbirth in a Chronic Pain Population
    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
    Women with child birth

    Women attending chronic pain clinic who have previously experienced childbirth

    Women without childbirth

    Women attending chronic pain clinic who have not previously experienced childbirth

    Outcome Measures

    Primary Outcome Measures

    1. Prevalence of chronic headache [10 minute questionnaire]

      Percentage of patients with chronic headache in women who have given birth and who have not given birth

    Secondary Outcome Measures

    1. Severity of headache [10 minute questionnaire]

      1 to 10 scale. 1 is almost no pain, 10 is worst pain imaginable

    2. Frequency of worst headache [10 minute questionnaire]

      How many days per month did patients have worst headaches

    3. Age of onset of headache [10 minute questionnaire]

      Age of onset of headache

    4. Postpartum headache [10 minute questionnaire]

      Percentage of headache in the postpartum period in women who have given birth

    5. Predictors for postpartum headache [10 minute questionnaire]

      Association between demographics/headache characteristics/predisposing risk factors and postpartum headache

    6. Risk factors for developing acute or acutely worsened headache within 5 days of delivery [10 minute questionnaire]

      Association between demographic, obstetric or anesthesia related factors and acute or acutely worsened headache within 5 days of delivery

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Women greater than 18 years old

    • Agreeing to be contacted for research purposes.

    • Able to read and understand English who have had agreed to be contacted with a valid email address

    Exclusion Criteria:
    • Self identified as non-female

    • Age <18 years old.

    • Women without computer or electronic device access or valid email address and women who did not respond

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Stanford University Stanford 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:
    NCT04632420
    Other Study ID Numbers:
    • 52732b
    First Posted:
    Nov 17, 2020
    Last Update Posted:
    Sep 21, 2021
    Last Verified:
    Sep 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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 21, 2021