NCT04632420

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.

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

Study Start

First participant enrolled

September 13, 2019

Completed
6 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
8 months until next milestone

First Submitted

Initial submission to the registry

October 30, 2020

Completed
18 days until next milestone

First Posted

Study publicly available on registry

November 17, 2020

Completed
Last Updated

April 11, 2023

Status Verified

April 1, 2023

Enrollment Period

6 months

First QC Date

October 30, 2020

Last Update Submit

April 10, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Prevalence of chronic headache

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

    10 minute questionnaire

Secondary Outcomes (6)

  • Severity of headache

    10 minute questionnaire

  • Frequency of worst headache

    10 minute questionnaire

  • Age of onset of headache

    10 minute questionnaire

  • Postpartum headache

    10 minute questionnaire

  • Predictors for postpartum headache

    10 minute questionnaire

  • +1 more secondary outcomes

Study Arms (2)

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

Eligibility Criteria

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

Women who went to the pain clinic and fulfill the inclusion and exclusion criteria.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Headache

Condition Hierarchy (Ancestors)

PainNeurologic 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

October 30, 2020

First Posted

November 17, 2020

Study Start

September 13, 2019

Primary Completion

February 26, 2020

Study Completion

February 26, 2020

Last Updated

April 11, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations