Detection of Epileptiform Activity in Severe Preeclampsia

NCT03494517 | Unknown

• 1 other identifier: DEpiPre2018
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

The primary aim of this pilot study is to prospectively quantify epileptiform activity in a cohort of preeclamptic patients before and after intravenous magnesium administration. Secondary aims will be the exploration of a potential association between epileptiform activity and the sFlt-1:PIGF ratio, as well as a correlation to clinical signs of preeclampsia. A positive finding may aid obstetricians to detect an increased convulsive risk by performing a simplified EEG early in the diagnostic path of preeclampsia. If confirmed in a larger trial positive correlations of an increased sFlt-1:PIGF ratio with epileptiform activity might be a risk marker for early severe preeclampsia, guiding obstetricians into clinical decision-making in regard to an increased maternal risk of eclampsia.

Conditions

Preeclampsia

Outcome Measures

Primary Outcomes (1)

• Epileptiform activity

  The primary aim of this pilot study is to prospectively quantify epileptiform activity in a cohort of preeclamptic patients before and after intravenous magnesium administration. Analysis of the EEG will include baseline spectral analysis (e.g. density spectral array), but the main focus will be the detection of epileptiform signals by absolute slope and ordinal pattern analysis.

  0-4h after Magnesium Sulfate administration

Secondary Outcomes (2)

• Biological correlates to epileptiform activity

  72h after inclusion

• Demographics of mother and infant

  72h after inclusion

Study Arms (1)

Preeclampsia

Women aged 18-45 years 1. Confirmed pregnancy \> 30 weeks of gestation 2. Singleton or multiple pregnancies 3. Admission in maternity of the Women's hospital with clinically suspected signs of severe preeclampsia: * Systolic blood pressure \>140 mmHg or diastolic pressure \> 90 mmHg and * Proteinuria \> 0.3 grams in a 24-hour urine or protein:creatinine ratio \>0.3 or * Signs of end-organ dysfunction (platelet count \< 100'000G/l, serum creatinine \>110 mg/l, or doubling of the serum creatinine, elevated serum transaminases to twice normal concentration)

Drug: Magnesium Sulfate

Interventions

Magnesium Sulfate DRUG

Baseline EEG measurement will be performed for 5 minutes before intravenous magnesium administration will start as defined by the administration scheme of the Women's Hospital of the Bern University Hospital. After completion of the bolus infusion and at the beginning of the maintenance infusion of magnesium the second EEG measure will be performed for another 5 minutes. After 4 hours of intravenous magnesium treatment the plasmatic magnesium concentration is expected to be at a steady-state. A third 5-minute measure will be performed at this time point.

Preeclampsia

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Preeclampsia in pregnant women

You may qualify if:

• Confirmed pregnancy \> 30 weeks of gestation
• Singleton or multiple pregnancies
• Admission in maternity of the Women's hospital with clinically suspected signs of severe preeclampsia:
• Systolic blood pressure \>140 mmHg or diastolic pressure \> 90 mmHg and
• Proteinuria \> 0.3 grams in a 24-hour urine or protein:creatinine ratio \>0.3 or
• Signs of end-organ dysfunction (platelet count \< 100'000G/l, serum creatinine \>110 mg/l, or doubling of the serum creatinine, elevated serum transaminases to twice normal concentration)

You may not qualify if:

• Lack of patient's informed consent
• Active labor
• Eclampsia
• Hypertensive crisis as defined by Systolic blood pressure \> 210 mmHg or diastolic pressure \> 120 mmHg
• Known epilepsy
• Posterior reversible encephalopathy syndrome
• Antiepileptic medication (except magnesium sulfate)
• Reported or admitted medication or substance abuse (street drugs, opiates, benzodiazepines, alcohol)
• Known neurologic condition with previously pathologic diagnostic imaging or EEG
• Severe fetal malformations (abdominal: gastroschisis \& omphalocele, tracheoesophageal fistula, cerebral: brain malformations included in the category of cephalic disorders, pulmonary: lung hypoplasia, cardiac: congenital heart disease)
• Preceding rupture of membranes
• Non-German and non-French speaking parturient

Sponsors & Collaborators

• Pascal Vuilleumier: lead

Study Sites (1)

Bern University Hospital

Bern, 3010, Switzerland

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

sFlt-1:PIGF ratio, LH, FSH, TSH, fT4, Oestradiol (E2), Progesterone. Magnesium levels after 4 hours of infusion (steady state), 48 and 72h.

MeSH Terms

Conditions

Pre-Eclampsia

Interventions

Magnesium Sulfate

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds

Study Officials

• Pascal H Vuilleumier, MD

  Bern University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pascal H Vuilleumier, MD

CONTACT

+41 31 632 82 39; pascal.vuilleumier@insel.ch

Heiko Kaiser, MD

CONTACT

+41 31 632 21 11; heiko.kaiser@insel.ch

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr. Med.

Study Record Dates

• First Submitted: April 3, 2018
• First Posted: April 11, 2018
• Study Start: January 1, 2019
• Primary Completion: December 20, 2019
• Study Completion: March 1, 2020
• Last Updated: January 24, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)