Saccadic Reaction Time and Preterm Pre-eclampsia

Pre-eclampsia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02613793
• Other study ID #: a11496
• Status: Terminated
• Start date: January 2016
• Est. completion date: May 30, 2019

Study information

• Verified date: May 2019
• Source: Oxford University Hospitals NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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].

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 9
• Est. completion date: May 30, 2019
• Est. primary completion date: May 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Eclampsia
• Pre-Eclampsia

Locations

Country	Name	City	State
United Kingdom	Oxford University Hospitals	Oxford

Sponsors (2)

Lead Sponsor	Collaborator
Oxford University Hospitals NHS Trust	University of Cambridge

Country where clinical trial is conducted

United Kingdom, 

References & Publications (14)

Altman D, Carroli G, Duley L, Farrell B, Moodley J, Neilson J, Smith D; Magpie Trial Collaboration Group. Do women with pre-eclampsia, and their babies, benefit from magnesium sulphate? The Magpie Trial: a randomised placebo-controlled trial. Lancet. 2002 Jun 1;359(9321):1877-90. — View Citation

Antoniades CA, Altham PM, Mason SL, Barker RA, Carpenter R. Saccadometry: a new tool for evaluating presymptomatic Huntington patients. Neuroreport. 2007 Jul 16;18(11):1133-6. — View Citation

Brown MA, Lindheimer MD, de Swiet M, Van Assche A, Moutquin JM. The classification and diagnosis of the hypertensive disorders of pregnancy: statement from the International Society for the Study of Hypertension in Pregnancy (ISSHP). Hypertens Pregnancy. 2001;20(1):IX-XIV. Review. — View Citation

Carpenter RHS. The saccadic system: a neurological microcosm. Advances in Clinical Neuroscience and Rehabilitation. 2004;4:6-8

Chandna A, Chandrasekharan DP, Ramesh AV, Carpenter RH. Altered interictal saccadic reaction time in migraine: a cross-sectional study. Cephalalgia. 2012 Apr;32(6):473-80. doi: 10.1177/0333102412441089. Epub 2012 Apr 5. — View Citation

Hikosaka O, Wurtz RH. Visual and oculomotor functions of monkey substantia nigra pars reticulata. I. Relation of visual and auditory responses to saccades. J Neurophysiol. 1983 May;49(5):1230-53. — View Citation

Irminger-Finger I, Jastrow N, Irion O. Preeclampsia: a danger growing in disguise. Int J Biochem Cell Biol. 2008;40(10):1979-83. doi: 10.1016/j.biocel.2008.04.006. Epub 2008 Apr 11. Review. — View Citation

Liddell E and Sherrington C, Reflexes in Response to Stretch (Myotatic Reflexes. Proceedings of the Royal Society of London. Series B, Containing Papers of a Biological Character, Vol. 96, No. 675 (May 1, 1924), pp. 212-242

Michell AW, Xu Z, Fritz D, Lewis SJ, Foltynie T, Williams-Gray CH, Robbins TW, Carpenter RH, Barker RA. Saccadic latency distributions in Parkinson's disease and the effects of L-dopa. Exp Brain Res. 2006 Sep;174(1):7-18. Epub 2006 Mar 17. — View Citation

Pearson BC, Armitage KR, Horner CW, Carpenter RH. Saccadometry: the possible application of latency distribution measurement for monitoring concussion. Br J Sports Med. 2007 Sep;41(9):610-2. Epub 2007 May 11. — View Citation

Sibai BM. Management of late preterm and early-term pregnancies complicated by mild gestational hypertension/pre-eclampsia. Semin Perinatol. 2011 Oct;35(5):292-6. doi: 10.1053/j.semperi.2011.05.010. Review. — View Citation

The world health report 2005 - Make every mother and child count. World Health Organization, Geneva (2005)

Tranquilli AL, Dekker G, Magee L, Roberts J, Sibai BM, Steyn W, Zeeman GG, Brown MA. The classification, diagnosis and management of the hypertensive disorders of pregnancy: A revised statement from the ISSHP. Pregnancy Hypertens. 2014 Apr;4(2):97-104. doi: 10.1016/j.preghy.2014.02.001. Epub 2014 Feb 15. — View Citation

Tuffnell, DJ, Shennan, AH, Waugh, JJS, and Walker, JJ. The management of severe pre-eclampsia/eclampsia, guideline number 10(A). Royal College of Obstetricians and Gynaecologists, London; 2006

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Saccadic reaction times in patients with preterm pre-eclampsia	Attainment of 3000 saccades from women with preterm pre-eclampsia	Baseline (Day 0)
Secondary	Comparison of median latency of saccadic reaction time	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
Secondary	Comparison of standard deviation of saccadic reaction time median latency	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
Secondary	Comparison of standard deviation of early saccadic reaction time median latency	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

External Links

•   The LATER model: Linear Approach to Threshold with Ergodic Rate