The PERFORM study: Pre-Eclampsia and other Risk FactORs in relation to Migraine
- Conditions
- Migraine, pre-eclampsia
- Registration Number
- NL-OMON24250
- Lead Sponsor
- Erasmus Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 600
Postpartum normotensive women or women with uncomplicated preexisting hypertension (group 1):
- Postpartum female adults aged =18 years;
- Women should either be normotensive or suffer from uncomplicated preexisting hypertension;
- Capable of understanding the purpose of the study, fully informed and given written informed consent (signed Informed Consent Form has been obtained).
A subset of group 1 will be asked to participate in the second part of the PERFORM study, which comprises the objective and subjective assessment of cognitive functioning and decline at the Erasmus MC. This subset of participants should include women who have had an uncomplicated and natural, non-assisted vaginal delivery (with a healthy baby born between 37 and 41 weeks). These women should also have had no complications during pregnancy and delivery, including hypertension or ruptures, which might have affected their mental state.
Postpartum women with (severe) pre-eclampsia, gestational hypertension, or superimposed hypertension/pre-eclampsia (group 2):
- Postpartum female adults aged =18 years;
- Postpartum women who have experienced a severe form of pre-eclampsia during pregnancy, or gestational hypertension, or superimposed hypertension/pre-eclampsia;
- Capable of understanding the purpose of the study, fully informed and given written informed consent (signed Informed Consent Form has been obtained).
All subjects of group 2 will be asked to participate in the second part of the PERFORM study, which comprises of the objective and subjective assessment of cognitive functioning and decline.
A (new) pregnancy within the first year after inclusion for the PERFOM study.
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The one-year (period) prevalence and incidence of migraine (both, migraine with aura and migraine without aura) among postpartum women who suffered from hypertensive disorders in pregnancy compared to the one-year (period) prevalence and incidence of migraine in (healthy) women – relative to prior pregnancy.
- Secondary Outcome Measures
Name Time Method 1. Trends (and changes) in migraine frequency and severity over time before, during and after pregnancy in women who suffered from severe pre-eclampsia compared to (healthy) women with an uncomplicated labor until one-year postpartum.<br>2. The (possible) association between cognitive functioning/impairment within the first year postpartum and hypertensive disorders as well as migraine.<br>3. Correlations between migraine prevalence, incidence and severity and the cardiovascular risk factors in women who have suffered from severe pre-eclampsia during pregnancy until one-year postpartum.<br>4. The impact of migraine and pre-eclampsia onset and trends on the mental wellbeing.