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The PERFORM study: Pre-Eclampsia and other Risk FactORs in relation to Migraine

Pre-Eclampsia and other Risk FactORs in relation to Migraine

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON24250
Enrollment
600
Registered
2021-05-12
Start date
2021-03-06
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Migraine, pre-eclampsia

Interventions

None listed

Sponsors

Erasmus Medical Center
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: A (new) pregnancy within the first year after inclusion for the PERFOM study.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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. 2. The (possible) association between cognitive functioning/impairment within the first year postpartum and hypertensive disorders as well as migraine. 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. 4. The impact of migraine and pre-eclampsia onset and trends on the mental wellbeing.

Contacts

Public ContactLinda Al-Hassany

Erasmus Medical Center

l.alhassany@erasmusmc.nl0684142771

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)