Headache Disorders, SecondaryNCT04091321
Association Between Chronic Headache and Back Pain With Childbirth
An observational study of Headache Disorders, Secondary and Post-Dural Puncture Headache, run by Stanford University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 years and older, women only
- Conditions the study is for
- Headache Disorders, Secondary, Post-Dural Puncture Headache, Migraine Disorders
- 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 10 years and older
- Women only
- Child, Adult, Older adult
Study population: Chronic pain patients who have elected to be contacted for research studies
Who may be able to join
- Female representation
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
Lucille Packard Children's Hospital
Palo Alto, California, 94305
About this study
This study uses a single questionnaire to evaluate two separate primary outcomes:
- 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
- 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
Read the 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.
- Conditions
- Headache Disorders, Secondary, Post-Dural Puncture Headache, Migraine Disorders, Back Pain, Anesthesia
- Medical subject headings
- Headache Disorders, Secondary, Post-Dural Puncture Headache, Migraine Disorders, Back Pain
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 |
|---|---|---|
| Chronic Headache | Women who endorse chronic headache | |
| Chronic Back Pain | Women who endorse chronic back pain |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 10 minute questionnaire
Secondary outcomes (3)
Migraine
Percent of patients with migraine who gave birth to children/Percent of patients with migraine who did not gave birth
Measured: 10 minute questionnaire
Temporal coincidence of headache and childbirth
Women who developed or had worse headache within one year of delivery compared to one year of starting to raise a child not delivered
Measured: 10 minute questionnaire
Temporal coincidence of headache and dural puncture
Women who developed or had worse headache within one year of dural puncture compared to those who did not have a dural puncture
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 posted16 Sep 2019
- 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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Headache Disorders, SecondaryStudies 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
- NCT04091321
- Sponsor's protocol ID
- 52732
- Status last verified
- Sep 2021
- First submitted
- 12 Sep 2019
- Last updated
- 24 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Depending on agreement. De identified data only
Publications
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.
PubMed 36597120
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Chronic Headache and Back Pain With Childbirth
- ClinicalTrials.gov ID
- NCT04091321
- Acronym / sponsor ID
- 52732
- Conditions
- Headache Disorders, Secondary, Post-Dural Puncture Headache, Migraine Disorders, Back Pain, Anesthesia
- 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
- 16 Sep 2019 (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.
This study uses a single questionnaire to evaluate two separate primary outcomes:
- 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
- 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
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chronic Headache | – | –Women who endorse chronic headache |
| Chronic Back Pain | – | –Women who endorse chronic back pain |
Who may qualify
- Ages
- 10 years and older
- Sex
- Female only
- Age groups
- Child, Adult, Older adult
- Study population
- Chronic pain patients who have elected to be contacted for research studies
Key inclusion criteria (1 listed)
- Female representation
Key exclusion criteria (1 listed)
- None
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
Chronic headache
Time frame: 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
Chronic back pain
Time frame: 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
3 secondary outcomes
Migraine
Time frame: 10 minute questionnaire
Temporal coincidence of headache and childbirth
Time frame: 10 minute questionnaire
Temporal coincidence of headache and dural puncture
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 24 Sep 2021.
- Derived from this study: PubMed 36597120Zhang 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.
- Individual participant dataSharing planned: Undecided. Depending on agreement. De identified data only
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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 Disorders, Secondary and Post-Dural Puncture 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 1 inclusion and 1 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 24 Sep 2021. 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?
Chronic headache (time frame: 10 minute questionnaire). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04091321, which also lists 1 linked publication.
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 24 Sep 2021.