Evaluation of Headache and Childbirth in a Chronic Pain Population

Headache Clinical Trial

Official title:

Evaluation of Headache and Childbirth in a Chronic Pain Population

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04632420
• Other study ID #: 52732b
• Status: Completed
• Start date: September 13, 2019
• Est. completion date: February 26, 2020

Study information

• Verified date: April 2023
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1112
• Est. completion date: February 26, 2020
• Est. primary completion date: February 26, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain
• Headache

Locations

Country	Name	City	State
United States	Stanford University	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Severity of headache	1 to 10 scale. 1 is almost no pain, 10 is worst pain imaginable	10 minute questionnaire
Secondary	Frequency of worst headache	How many days per month did patients have worst headaches	10 minute questionnaire
Secondary	Age of onset of headache	Age of onset of headache	10 minute questionnaire
Secondary	Postpartum headache	Percentage of headache in the postpartum period in women who have given birth	10 minute questionnaire
Secondary	Predictors for postpartum headache	Association between demographics/headache characteristics/predisposing risk factors and postpartum headache	10 minute questionnaire
Secondary	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	10 minute questionnaire