Saccadic Reaction Time and Preterm Pre-eclampsia

May 30, 2019 updated by: Lucy MacKillop, Oxford University Hospitals NHS Trust

A Prospective Case Control Feasibility Study to Investigate the Utility of Saccadometry in the Diagnosis and Monitoring of Preterm Pre-eclampsia

This study is recruiting two groups of women over the age of 18; those who are pregnant and who have pre-eclampsia; and those who are pregnant but do not have pre-eclampsia. The aim is to test a new method of diagnosing and monitoring pre-eclampsia and thus prevent the long-term damage it can cause to the baby's health. Untreated, pre-eclampsia can lead to seizures in pregnancy (eclampsia) and may prove fatal for mother and child.

Currently the only effective treatment for pre-eclampsia is control of the mother's blood pressure until it is safe to deliver the baby. The timing of delivery is kept under constant review by the medical team, who must balance the risk to the mother of developing eclampsia against the risk to the baby of being born too early (premature).

If pre-eclampsia can be diagnosed early, there is a greater chance of being able to treat it effectively. We know that women with pre-eclampsia often have exaggerated reflexes in their limbs (hyperreflexia) and that this may be linked to the risk of seizures. Measuring these reflexes might therefore be a useful way to diagnose and monitor pre-eclampsia, but doing this is not easy, so we want to assess whether measuring other reaction times might similarly help assess the risk of seizures. One possibility is by measuring the reaction time as we flick our eyes to follow a moving target, using an instrument called a saccadometer, which is worn on a head-band, a little like a head-torch.

By comparing the results between these groups and the non-pregnant women, we will be able to see if reaction times from the saccadometer are altered in women with pre-eclampsia, and, if so, whether saccadometry might be useful in helping doctors decide the best time for safe delivery.

Study Overview

Status

Terminated

Conditions

Detailed Description

Prospective feasibility study with two arms; (i) case-control comparisons of saccadic reaction time distributions between patients with preterm pre-eclampsia, age- and gestation-matched pregnant controls and age-matched female non-pregnant controls [cross-sectional analysis]; (ii) intra-individual comparisons of antenatal and postnatal saccadic reaction time distributions of patients with preterm pre-eclampsia [longitudinal analysis].

Study Type

Observational

Enrollment (Actual)

9

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Pregnant patients with preterm pre-eclampsia diagnosed earlier than 35 weeks gestation (cases) and healthy age- and gestation-matched pregnant patients (controls)

Description

Inclusion criteria for cases:

  1. Age ≥ 18 years
  2. Confirmed diagnosis of pre-eclampsia, as defined by the International Society for the Study of Hypertension in Pregnancy (ISSHP)
  3. Gestational age < 35+0 weeks
  4. Participant is willing and able to give informed consent

Inclusion criteria for controls:

  1. Age ≥ 18 years
  2. Absence of essential hypertension and pre-eclampsia or pregnancy-induced hypertension in current and previous pregnancies
  3. Gestational age < 35+0 weeks
  4. Participant is willing and able to give informed consent

Exclusion Criteria:

  1. Maternal neurological or psychiatric disorder (e.g. epilepsy, migraine, multiple sclerosis, depression, etc.)
  2. Use of medication (other than vitamin supplements [cases and controls] and those for treatment or prevention of pre-eclampsia [cases]) during pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Preterm pre-eclampsia (cases)
Pregnant patients diagnosed with pre-eclampsia prior to 35 weeks gestation
Pregnant patients (controls)
Age- and gestation-matched pregnant patients who are not suffering with pre-eclampsia, hypertensive disease or any other neuropsychiatric condition

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Saccadic reaction times in patients with preterm pre-eclampsia
Time Frame: Baseline (Day 0)
Attainment of 3000 saccades from women with preterm pre-eclampsia
Baseline (Day 0)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of median latency of saccadic reaction time
Time Frame: Baseline (Day 0), twice per week from Day 0 for the duration of hospital stay (which is anticipated to be a maximum 10 weeks from Day 0), and then at Day 1, 5 and 42 postpartum
Intra-individual and case control comparisons of saccadic reaction time median latency
Baseline (Day 0), twice per week from Day 0 for the duration of hospital stay (which is anticipated to be a maximum 10 weeks from Day 0), and then at Day 1, 5 and 42 postpartum
Comparison of standard deviation of saccadic reaction time median latency
Time Frame: Baseline (Day 0), twice per week from Day 0 for the duration of hospital stay (which is anticipated to be a maximum 10 weeks from Day 0), and then at Day 1, 5 and 42 postpartum
Intra-individual and case control comparisons of standard deviation of saccadic reaction time median latency
Baseline (Day 0), twice per week from Day 0 for the duration of hospital stay (which is anticipated to be a maximum 10 weeks from Day 0), and then at Day 1, 5 and 42 postpartum
Comparison of standard deviation of early saccadic reaction time median latency
Time Frame: Baseline (Day 0), twice per week from Day 0 for the duration of hospital stay (which is anticipated to be a maximum 10 weeks from Day 0), and then at Day 1, 5 and 42 postpartum
Intra-individual and case control comparisons of standard deviation of early saccadic reaction time median latency
Baseline (Day 0), twice per week from Day 0 for the duration of hospital stay (which is anticipated to be a maximum 10 weeks from Day 0), and then at Day 1, 5 and 42 postpartum

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oxford University Hospitals NHS Trust

Collaborators

University of Cambridge

Investigators

  • Principal Investigator: Lucy Mackillop, BM BCh FRCP, Oxford University Hospitals NHS Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (Actual)

May 30, 2019

Study Completion (Actual)

May 30, 2019

Study Registration Dates

First Submitted

September 2, 2015

First Submitted That Met QC Criteria

November 22, 2015

First Posted (Estimate)

November 25, 2015

Study Record Updates

Last Update Posted (Actual)

June 3, 2019

Last Update Submitted That Met QC Criteria

May 30, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • a11496

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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