Saccadic Reaction Time and Preterm Pre-eclampsia

NCT02613793 | Terminated

• 1 other identifier: a11496
• Study Type: observational
• Target: 9
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pre-eclampsia

Keywords

Preterm pre-eclampsia; Neurological dysfunction; Saccadic reaction time

Outcome Measures

Primary Outcomes (1)

• Saccadic reaction times in patients with preterm pre-eclampsia

  Attainment of 3000 saccades from women with preterm pre-eclampsia

  Baseline (Day 0)

Secondary Outcomes (3)

• Comparison of median latency of saccadic reaction time

  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

  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

  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

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

• Age ≥ 18 years
• Confirmed diagnosis of pre-eclampsia, as defined by the International Society for the Study of Hypertension in Pregnancy (ISSHP)
• Gestational age \< 35+0 weeks
• Participant is willing and able to give informed consent
• Age ≥ 18 years
• Absence of essential hypertension and pre-eclampsia or pregnancy-induced hypertension in current and previous pregnancies
• Gestational age \< 35+0 weeks
• Participant is willing and able to give informed consent

You may not qualify if:

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

Sponsors & Collaborators

• Oxford University Hospitals NHS Trust: lead
• University of Cambridge: collaborator

Study Sites (1)

Oxford University Hospitals

Oxford, United Kingdom

Location

Related Publications (14)

• 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

  BACKGROUND

• 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.

  PMID: 18499505 BACKGROUND

• Hogberg U. The World Health Report 2005: "make every mother and child count" - including Africans. Scand J Public Health. 2005;33(6):409-11. doi: 10.1080/14034940500217037. No abstract available.

  PMID: 16332605 BACKGROUND

• 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. doi: 10.1081/PRG-100104165. No abstract available.

  PMID: 12044323 BACKGROUND

• 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. doi: 10.1016/s0140-6736(02)08778-0.

  PMID: 12057549 BACKGROUND

• 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.

  PMID: 21962629 BACKGROUND

• 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

  BACKGROUND

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

  BACKGROUND

• 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. doi: 10.1152/jn.1983.49.5.1230. No abstract available.

  PMID: 6864248 BACKGROUND

• 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. doi: 10.1097/WNR.0b013e32821c560d.

  PMID: 17589313 BACKGROUND

• 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. doi: 10.1007/s00221-006-0412-z. Epub 2006 Mar 17.

  PMID: 16544135 BACKGROUND

• 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.

  PMID: 22492423 BACKGROUND

• 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. doi: 10.1136/bjsm.2007.036731. Epub 2007 May 11.

  PMID: 17496064 BACKGROUND

• 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. No abstract available.

  PMID: 26104417 BACKGROUND

MeSH Terms

Conditions

Pre-Eclampsia

Condition Hierarchy (Ancestors)

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

Study Officials

• Lucy Mackillop, BM BCh FRCP

  Oxford University Hospitals NHS Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Obstetric Physician

Study Record Dates

• First Submitted: September 2, 2015
• First Posted: November 25, 2015
• Study Start: January 1, 2016
• Primary Completion: May 30, 2019
• Study Completion: May 30, 2019
• Last Updated: June 3, 2019

Record last verified: 2019-05

Locations

GB (1)