HeadacheNCT04632420
Evaluation of Headache and Childbirth in a Chronic Pain Population
An observational study of Headache, run by Stanford University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Headache
- How many people
- 1,112 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Sep 2019to 26 Feb 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Women who went to the pain clinic and fulfill the inclusion and exclusion criteria.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Headache
- Medical subject headings
- Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of chronic headache
Percentage of patients with chronic headache in women who have given birth and who have not given birth
Measured: 10 minute questionnaire
Secondary outcomes (6)
Severity of headache
1 to 10 scale. 1 is almost no pain, 10 is worst pain imaginable
Measured: 10 minute questionnaire
Frequency of worst headache
How many days per month did patients have worst headaches
Measured: 10 minute questionnaire
Age of onset of headache
Age of onset of headache
Measured: 10 minute questionnaire
Postpartum headache
Percentage of headache in the postpartum period in women who have given birth
Measured: 10 minute questionnaire
Predictors for postpartum headache
Association between demographics/headache characteristics/predisposing risk factors and postpartum headache
Measured: 10 minute questionnaire
Risk factors for developing acute or acutely worsened headache within 5 days of delivery
Association between demographic, obstetric or anesthesia related factors and acute or acutely worsened headache within 5 days of delivery
Measured: 10 minute questionnaire
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2020
- Study start13 Sep 2019
- Primary completion26 Feb 2020
- Study completion26 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HeadacheStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pamela Flood, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04632420
- Sponsor's protocol ID
- 52732b
- Status last verified
- Apr 2023
- First submitted
- 30 Oct 2020
- Last updated
- 11 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Headache and Childbirth in a Chronic Pain Population
- ClinicalTrials.gov ID
- NCT04632420
- Acronym / sponsor ID
- 52732b
- Conditions
- Headache
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,112 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 13 Sep 2019 (actual)
- Primary completion
- 26 Feb 2020 (actual)
- Study completion
- 26 Feb 2020 (actual)
- First posted
- 17 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Women who went to the pain clinic and fulfill the inclusion and exclusion criteria.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence of chronic headache
Time frame: 10 minute questionnaire
Percentage of patients with chronic headache in women who have given birth and who have not given birth
6 secondary outcomes
Severity of headache
Time frame: 10 minute questionnaire
Frequency of worst headache
Time frame: 10 minute questionnaire
Age of onset of headache
Time frame: 10 minute questionnaire
Postpartum headache
Time frame: 10 minute questionnaire
Predictors for postpartum headache
Time frame: 10 minute questionnaire
Risk factors for developing acute or acutely worsened headache within 5 days of delivery
Time frame: 10 minute questionnaire
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Headache, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of chronic headache (time frame: 10 minute questionnaire). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2023.