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OpenTrials
Completed

NCT Number: NCT04632420

Evaluation of Headache and Childbirth in a Chronic Pain Population

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.

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Key information

Conditions

Headache Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Stanford University

Stanford, California, 94305, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. Severity of headache

    Time frame: 10 minute questionnaire

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

  2. Frequency of worst headache

    Time frame: 10 minute questionnaire

    How many days per month did patients have worst headaches

  3. Age of onset of headache

    Time frame: 10 minute questionnaire

    Age of onset of headache

  4. Postpartum headache

    Time frame: 10 minute questionnaire

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

  5. Predictors for postpartum headache

    Time frame: 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

    Time frame: 10 minute questionnaire

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

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Nov 17, 2020
Registry last updated
Apr 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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